BHS Connect https://bhsconnect.net Fri, 17 Jan 2020 18:00:33 +0000 en-US hourly 1 https://wordpress.org/?v=5.3.2 https://bhsconnect.net/wp-content/uploads/2018/08/bhs-logo-111x111-100x100.png BHS Connect https://bhsconnect.net 32 32 Red Blood Cells Made Into Drug Delivery Devices https://bhsconnect.net/red-blood-cells-made-into-drug-delivery-devices/ Fri, 17 Jan 2020 18:00:33 +0000 https://bhsconnect.net/red-blood-cells-made-into-drug-delivery-devices/ January 17th, 2020 Medgadget Editors Medicine Many of the existing diseases that strike us are poorly treated not because effective drugs don’t exist, but because there’s no reliable way of delivering the drugs to their intended destinations. Anyone following this publication will be familiar with the dozens of types of synthetic vessel that scientists have...

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Many of the existing diseases that strike us are poorly treated not because effective drugs don’t exist, but because there’s no reliable way of delivering the drugs to their intended destinations. Anyone following this publication will be familiar with the dozens of types of synthetic vessel that scientists have created to ferry drugs to tumors, infections, and other disease sites. These tend to be suspicious to the immune system and often end up not functioning inside the body as expected.

Now, researchers at McMaster University in Canada have developed a way of emptying red blood cells, filling them with drugs, attaching a homing mechanism, and sending them out to find specific targets. “We call these super-human red blood cells,” said Maikel Rheinstädter, a senior advisor on the study, in a press release. “We think that they could work as the perfect stealth drug carriers which can outsmart our immune system.”

To make this possible, the team modified the surface of red blood cells to make them attracted and stick to certain tissues, organs, or bacteria. In the process, they were able to replace the molecular insides of the red blood cells with drug compounds and to reconstruct the cell membranes so they again seem like normal blood cells. These modified cell constructs can then be injected into the body without triggering an immune response.

“We have combined synthetic material with biological material and created a new structure, which has never been done before in this way,” said Sebastian Himbert, lead author of the study.

Here’s a McMaster University video describing the research:

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Study in journal Advanced Biosystems: Hybrid Erythrocyte Liposomes: Functionalized Red Blood Cell Membranes for Molecule Encapsulation

Via: McMaster University

Medgadget Editors

Medical technologies transform the world! Join us and see the progress in real time. At Medgadget, we report the latest technology news, interview leaders in the field, and file dispatches from medical events around the world since 2004.

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FDA Clears Morph DNA Catheter to Guide Cell Delivery into Heart Tissue https://bhsconnect.net/fda-clears-morph-dna-catheter-to-guide-cell-delivery-into-heart-tissue/ Fri, 17 Jan 2020 17:20:44 +0000 https://bhsconnect.net/fda-clears-morph-dna-catheter-to-guide-cell-delivery-into-heart-tissue/ BioCardia, a Silicon Valley firm, won FDA clearance for its Morph DNA catheter, a device developed to help with delivery of the company’s CardiAMP cell therapy into the heart. CardiAMP involves depositing a patient’s own bone marrow cells into heart tissue, with the intention of jump starting the body’s natural healing processes to reverse previous...

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BioCardia, a Silicon Valley firm, won FDA clearance for its Morph DNA catheter, a device developed to help with delivery of the company’s CardiAMP cell therapy into the heart. CardiAMP involves depositing a patient’s own bone marrow cells into heart tissue, with the intention of jump starting the body’s natural healing processes to reverse previous damage that has occurred in the heart.

The Morph DNA deflectable catheter is used to guide the Helix delivery system toward multiple targets inside the heart. The Helix injects cell therapy agents directly into cardiac tissue, potentially resulting in significant benefits to patients.

The Morph DNA features bidirectional deflection, a low tendency for torque build up and whip lash, better visibility under the fluoroscope, and an ergonomic design, according to the company. The new catheter uses pull wires that are braided into a helix, similar to DNA strands, an arrangement that gives the device its name. This configuration helps to reduce whips when navigating around curvy vasculature and when inside the heart.

“The Morph DNA deflectable guide enables navigation within the cardiac chambers without building up torque. This is hugely beneficial for controlling the delivery of therapeutic catheters, such as Helix. The ergonomic features simplify the handling and can reduce procedural delays,” said Gerald Koenig, MD, PhD, cardiologist and principal investigator of the CardiAMP Heart Failure Trial at Henry Ford Health System, in a press release.

“Our investigational Helix delivery system using the original Morph technology has shown a great safety profile and has been shown to be dramatically more efficient in helping the heart retain cell therapy when compared to other leading delivery approaches,” added BioCardia CEO Peter Altman, PhD. “The new Morph DNA device is an elegant product intended to further enhance the performance of our biotherapeutic delivery capabilities, and through these, our CardiAMP and CardiALLO cell therapy programs.”

Here’s a Biocardia video describing the Helix delivery system:

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Product page: Helix Biotherapeutic Delivery System

Flashbacks: BioCardia’s Intramyocardial Stem Cell Delivery Catheter System Gets European Approval;

Related studies: Improvement of Local Cell Delivery Using Helix Transendocardial Delivery Catheter in a Porcine Heart; Not All Stem Cells Are Created Equal

Via: Biocardia

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Fluorescent Tags That Can’t Be Copied to Verify Authentic Drugs https://bhsconnect.net/fluorescent-tags-that-cant-be-copied-to-verify-authentic-drugs/ Fri, 17 Jan 2020 15:23:16 +0000 https://bhsconnect.net/fluorescent-tags-that-cant-be-copied-to-verify-authentic-drugs/ January 17th, 2020 Medgadget Editors Informatics, Materials, Medicine Sales of counterfeit drugs are disturbingly common around the world. Some patients end up not receiving necessary treatments, while others are harmed by ingesting whatever substances are inside the fake pills. Researchers at Purdue University have now come up with a way to tag medications so that...

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Sales of counterfeit drugs are disturbingly common around the world. Some patients end up not receiving necessary treatments, while others are harmed by ingesting whatever substances are inside the fake pills. Researchers at Purdue University have now come up with a way to tag medications so that forgers can’t do the same to their fakes.

The researchers created tiny digestible films, made of proteins, that can be stuck to pills and tablets, and which have fluorescent particles that display digital signatures that are extremely difficult to copy. These so-called “edible unclonable functions” are a variation on physical unclonable functions (PUFs) that have been developed for hardware security and to verify data source authenticity.

Fluorescent silk microparticles arrange into patterns that would be extremely difficult for drug counterfeiters to duplicate. The patterns act as a fingerprint that pharmacies and consumers could use to verify that a drug is authentic. (Purdue University photo/Jung Woo Leem)

Made of silk protein and one of a number of various colored fluorescent proteins, the tags fluoresce when exposed to an LED light source. Each time they’re activated they produce a different pattern, which makes them very hard to copy. Even the original maker of the tag will find it nearly impossible to recreate it. The various patterns that the tags make have a digital security key embedded within them that can be verified using an appropriate computer vision algorithm. This can be built into a smartphone app, and if the phone has the right kind of light source that can activate the tag, it can be used to check the validity of the drug the tag is attached to.

Along with the security key, the fluorescence pattern can also encode other information such as the drug expiry date, who manufactured it, and other relevant data that may be important to patients, regulators, and drug makers.

Here’s a Purdue University video with the researchers showing off and describing their technology:

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Study in Nature Communications: Edible unclonable functions

Flashbacks: Chronoprints: A Computer Vision Way to Test for Counterfeit Drugs; Eliminating Counterfeit Drugs from the Pharmaceutical Supply Chain: Interview with FarmaTrust CEO; Paper Test to Detect Fake Medications; Simple Musical Instrument to Catch Fake Medicine

Via: Purdue

Medgadget Editors

Medical technologies transform the world! Join us and see the progress in real time. At Medgadget, we report the latest technology news, interview leaders in the field, and file dispatches from medical events around the world since 2004.

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PENTAX Releases IMAGINA LED Powered Endoscopy System https://bhsconnect.net/pentax-releases-imagina-led-powered-endoscopy-system/ Thu, 16 Jan 2020 16:42:16 +0000 https://bhsconnect.net/pentax-releases-imagina-led-powered-endoscopy-system/ January 16th, 2020 Medgadget Editors GI PENTAX is releasing its IMAGINA Endoscopy System in the U.S., having just received FDA clearance for the GI imaging platform. The endoscope sports two powerful and long lasting LEDs at the tip that do not require regular replacement, unlike traditional bulbs that can be costly to regularly swap for...

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PENTAX is releasing its IMAGINA Endoscopy System in the U.S., having just received FDA clearance for the GI imaging platform.

The endoscope sports two powerful and long lasting LEDs at the tip that do not require regular replacement, unlike traditional bulbs that can be costly to regularly swap for new ones. Given enough procedures, a clinic can end up saving significant amounts by using the IMAGINA over a system containing conventional bulbs. The system also features a HD+ CMOS light sensor and a touchscreen display on the control unit with 1080p resolution.

A combination of high end illumination with high resolution imaging allows for viewing of tissue texture, blood vessels, and targets of interest. “What I really like about the IMAGINA is that it’s not just a small improvement to what we already have,” said Dr. Stepan Suchanek, Centre for Gastrointestinal Endoscopy, Prague, Czech Republic, in a PENTAX press release. “It’s a completely new concept in endoscopy, featuring new technology that delivers superior visualization with an attractive cost model. Overall, it helps us provide efficient and effective treatment while reducing financial burdens to the health system.”

“We feel that today’s ASC market is underserved,” said David Woods, President and CEO of PENTAX Medical, Americas. “These practices are often limited to used or previous-generation equipment to stay within budget. The launch of the IMAGINA allows us to best serve the needs of the core GI market and our system provides maximum cost predictability without compromising on the standard of care delivered to patients. IMAGINA eliminates the costliest components of a premium GI endoscopy system and still adheres to the highest imaging standards in the industry: a true testament to our commitment to better patient outcomes, improved patient experience and a lower overall cost of care.”

Product page: IMAGINA Endoscopy System

Flashback: PENTAX Medical’s DEC HD Partially Disposable Duodenoscope FDA Cleared

Medgadget Editors

Medical technologies transform the world! Join us and see the progress in real time. At Medgadget, we report the latest technology news, interview leaders in the field, and file dispatches from medical events around the world since 2004.

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IoT Cybersecurity Regulations and Embedded Protection from Sternum (Interview) https://bhsconnect.net/iot-cybersecurity-regulations-and-embedded-protection-from-sternum-interview/ Wed, 15 Jan 2020 19:26:07 +0000 https://bhsconnect.net/iot-cybersecurity-regulations-and-embedded-protection-from-sternum-interview/ By 2025, an estimated 75 billion internet of things (IoT) devices are predicted to be in use worldwide. This includes the growing number of connected medical devices, such as pacemakers, that patients rely on to sustain life. While some regulation related to securing healthcare data exists, governance related to protecting the devices themselves is inadequate...

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By 2025, an estimated 75 billion internet of things (IoT) devices are predicted to be in use worldwide. This includes the growing number of connected medical devices, such as pacemakers, that patients rely on to sustain life. While some regulation related to securing healthcare data exists, governance related to protecting the devices themselves is inadequate despite the increasing risk of malicious attacks on these digitally-accessible medical technologies.

Medgadget has previously spoken with emerging cybersecurity companies who recognize the risks of compromised medical technology and are building solutions to address the challenge. To learn more about the regulatory landscape surrounding IoT, Medgadget spoke with Natali Tshuva, CEO of Sternum, an Israeli startup offering multilayered cybersecurity for embedded IoT protection. We also had a chance to hear more about Sternum’s IoT cybersecurity solutions which currently serve healthcare as well as other industries where connected devices are becoming increasingly prevalent.

See Sternum’s commentary on the FDA’s Content of Premarket Submissions for Management of Cybersecurity in Medical Devices draft guidance here.

Medgadget: The dialogue around healthcare security usually
includes references to HIPAA compliance and HITRUST certification. Can you give
us some grounding in how those standards apply to IoT device security and what
it means for an IoT technology company to claim that it has achieved either
standard? Are there other regulatory standards to which IoT device companies
currently must adhere?

Natalie Tshuva, CEO, Sternum

Natali Tshuva: To understand the relevance of these regulations in medical IoT, it’s essential to differentiate between health technology security as it pertains to protected health information (PHI) and the security of medical IoT devices themselves. HIPAA addresses PHI and HITRUST addresses information security risk management and privacy, but neither address the security of actual IoT devices. Additionally, neither address on-device security, hardening devices against cyber attacks, reporting cyber incidents, or preventing malicious code from running on a device. This does not mean, however, that the standards set out by these regulations are not important, and we hope these regulations evolve to include guidance for IoT device cybersecurity.

That said, there are other regulatory standards concerning IoT device security, for example, standards by the FDA and NIST in the US, and ENISA in the EU. While these standards do touch on important points such as real-time monitoring, none are mandatory and most are still in the process of being drafted and established. With billions of IoT devices now in use, this is the time for regulations and industry standards to be put into place to ensure security and device integrity. Regulators have put an incredible amount of resources into achieving these standards so far. I think to further this mission the industry needs one to two mandatory standards or regulations that are clear and precise when it comes to IoT device security. These regulations should send a clear message to device manufacturers that security is a fundamental requirement. These regulations should be based off of traditional cybersecurity solutions, but adjusted to fit the unique nature of IoT. 

Medgadget: Despite the existence of some regulations, what
gaps or risks still exist?

Tshuva: The cyber risks IoT device manufacturers face remain significant.
This is what motivated us to develop our product in the first place. We looked
at the medical sector, as well as multiple other industries, and saw how
billions of IoT devices were connected to the internet, yet proper end-to-end
security solutions that protected these devices were largely non-existent. The
guidelines set out by HIPAA and HITRUST are focused on PHI and do not touch on
proper on-device security protocols. We cannot wait for regulation to catch up
to the constantly evolving cybersecurity threats we face today. 

IoT Cybersecurity should not only mean protection of PHI on
networks (which HIPAA and HITRUST are largely focused on and which exclude IoT
devices that are not part of a network or contain PHI). It needs to include
total protection of IoT devices themselves, including preventing hacks, knowing
if your device experienced a breach, and stopping denial-of-service (DoS)
attacks. Hackers have learned how to exploit vulnerabilities within an IoT
device in order to bypass encryption. Robust cybersecurity solutions must be
one step ahead of these hackers by ensuring immunity to vulnerability
exploitation on a device and enabling visibility into potential future attacks.
This includes protection and monitoring of third party code that OEMs and
enterprises cannot control. Without effective cybersecurity solutions in place,
the results of a hack on a sensitive medical device could be lethal,
particularly if devices are manipulated to not act as they should. 

Medgadget: What are the risks to device companies who fail
to properly secure their technologies? What are examples of IoT-specific
breaches that have resulted in significant harm?

Tshuva: IoT device companies must be aware that cyber risks do not solely threaten the connected devices themselves but have become the gateway of choice for an increasing amount of network intrusions. With 75 billion IoT devices predicted to be in use in the coming years, it’s critical to include security solutions on the devices themselves. Network protection is proving incapable of adequately preventing cyber breaches from IoT devices. And when we are dealing with high-value IoT medical devices such as pacemakers, cyber attacks could ultimately be lethal. There is also, of course, the physical and financial ramifications of cyber attacks. 

The WannaCry ransomware attack in 2017 is an example of the risks posed to connected devices in the medical industry. In addition to the tens of hospitals in the UK and unnamed medical facilities in the US that were hit hard by the massive malware attack, the ransomware also appeared on a Bayer Medrad device used to improve imaging in the radiology department of a US hospital. The device, connected to the hospital network, only demonstrates how one vulnerable connected device could spell trouble for an entire system. Also in 2017, we saw the FDA warn that implantable cardiac devices designed by St. Jude Medical were at high risk. 

Medgadget: Turning our attention to Sternum, how does the company
solve some of the challenges you’ve identified?

Tshuva: We tackled these challenges by creating a multilayered
cybersecurity solution that offers real-time, on-device protection for
individual IoT devices. We understood right away that other security solutions
were hyper-focused on two things – patching every vulnerability on the device
itself and attempting to protect the entire network. Yet it’s nearly impossible
to identify every weak point on a device and it’s not effective for enterprises
to simply ignore endpoint protection. This is especially true for distributed
devices, like homecare medical devices, as it is impossible to deploy a network
security solution into these unmanaged and uncontrolled environments.

Our product suite offers on-device, real-time protection from both
known and unknown threats, ensuring immunity to vulnerability exploitation.
Simultaneously, our solution focuses on the monitoring of a company or OEM’s
device fleets, enabling visibility into all devices and potential future
attacks. First, our Embedded Integrity Verification (EIV) operates like an
on-device firewall – it validates each and every operation within the IoT
device to ensure overall device integrity at all times, including protection of
sensitive data within it. Second, our Real-time IoT Event Monitoring System
(RIEMS) provides first-of-its-kind visibility from within individual IoT
devices (including 3rd party components) so that OEMs, enterprises, and
consumers are immediately alerted to indications of any cyber breach, as well
as prevented attack attempts. Both EIV and RIEMS work symbiotically: while
RIEMS continuously collects and monitors cyber and operational events, EIV
proactively prevents attack attempts in real-time. 

Medgadget: Who are Sternum’s customers? How do those
customers gain peace of mind that the IoT solutions they deploy are secure?

Tshuva: Sternum’s customers include a number of OEMs in various sectors including healthcare, industry 4.0, smart cities, and energy. Our product solution is designed for OEMs who produce IoT devices, enterprises that implement them, and end-point consumers who ultimately use them. Since our solution is uniquely embedded throughout the device’s code (including 3rd party components), we are empowering IoT devices with self-protection techniques to armor themselves with real-time prevention from cyber attacks. Our product also gives users unprecedented visibility into their entire device fleet. This means OEMs and medical companies can track devices’ activities, receive alerts on mitigated attacks or attempted breaches, and manage 3rd party code, all via a simplified interface. 

Medgadget: How easy is it for an IoT device company to
integrate with Sternum’s solution? What is the range of IoT devices with
which Sternum can be integrated?

Tshuva: The integration process is very simple. Our flexible internet of
medical things (IoMT) security solutions can be integrated into existing
R&D environments and work seamlessly with any operating system and/or
development process. We are a software-only solution, meaning that no special
hardware, operating system, or additional platform is required. Once our
solution is integrated, customers are able to continuously protect the entirety
of their code automatically, including newly added code and third-party
components. Monitoring capabilities are also embedded automatically and utilize
existing connectivity within target IoT devices to deliver real-time alerts.

Sternum’s solution is capable of being installed on any IoT device in any industry, including medical, industry 4.0, smart cities, and energy sectors. As a high-diversity and platform-agnostic solution, Sternum currently stands as the only on-device, real-time cybersecurity solution supporting all types of real-time operating systems (RTOS).

Medgadget: How does Sternum differentiate against
other competitors in the IoT cybersecurity market?

Tshuva: Our competitors can be split into two main groups: network-based solutions that do not address the need for on-device security and endpoint-focused secure-development tools, like MedCrypt, that lack real-time protection or deep visibility after an IoT device is deployed. What makes us unique is the fact that we offer both innovative on-device, real-time protection and unprecedented visibility into the device. We are the only on-device, real-time cybersecurity solution supporting all types of RTOS. Plus, when utilizing Sternum’s EIV solution, our cyber attack prevention rate is nearly perfect. 

Medgadget: Sternum services other industries outside of healthcare. Did Sternum start in healthcare and how did Sternum get to where it is today providing cybersecurity solutions for multiple verticals?

Tshuva: We did start in healthcare! It was immediately obvious to me how vulnerable lifesaving medical devices are to potentially fatal hacks. The IoMT industry craved a comprehensive cybersecurity solution that could defend medical devices such as pacemakers and insulin pumps by mitigating known threats, while simultaneously adapting to and combating new ones. Existing solutions were either too focused on the security of PHI or protecting entire hospital networks, as opposed to securing medical IoT devices themselves. We created a multilayered approach that ensured the on-device security the medical industry needed. We soon realized our solution could be applicable to big markets outside of medical so we decided to expand.

Link: Sternum homepage…

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Percept PC Deep Brain Neurostimulator with BrainSense Cleared in Europe https://bhsconnect.net/percept-pc-deep-brain-neurostimulator-with-brainsense-cleared-in-europe/ Wed, 15 Jan 2020 16:40:56 +0000 https://bhsconnect.net/percept-pc-deep-brain-neurostimulator-with-brainsense-cleared-in-europe/ January 15th, 2020 Medgadget Editors Neurology, Neurosurgery Medtronic obtained the European CE Mark for its Percept PC neurostimulator that uses smart feedback technology to deliver deep brain stimulation to treat Parkinson’s and other neurologic diseases. The so-called BrainSense technology powering the Percept PC can record brain signals at the same time that it delivers therapy....

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Medtronic obtained the European CE Mark for its Percept PC neurostimulator that uses smart feedback technology to deliver deep brain stimulation to treat Parkinson’s and other neurologic diseases.

The so-called BrainSense technology powering the Percept PC can record brain signals at the same time that it delivers therapy.

It is compatible with full-body MRI scans in scanners up to 3 Tesla, allowing patients to continue to receive necessary imaging. The implant has a longer battery capacity than Medtronic’s Activa PC deep brain neurostimulator while having a smaller body.

A short pulse width lets the device provide a wider array of stimulation capabilities, which physicians can take advantage of to achieve optimal results. Moreover, the potential to upgrade the system will be useful in the future when expanded capabilities are introduced by Medtronic via a simple software update.

“DBS is proven to significantly improve motor function in people with Parkinson’s disease compared to standard medication alone – but with currently-available systems, physicians need to make therapeutic decisions mostly based on clinical assessments and patient-reported information,” said Professor Andrea Kühn, head of Movement Disorders and Neuromodulation, Charité University Hospital, Berlin, in a Medtronic announcement. “Percept PC with BrainSense technology is a game changer. Patients and their care teams will have objective patient-specific brain signal data – including data recorded outside the clinic in patients’ everyday lives. With this technology, doctors could tailor therapy more precisely to the individual needs of each patient based on data from neuronal activity.”

Via: Medtronic

Medgadget Editors

Medical technologies transform the world! Join us and see the progress in real time. At Medgadget, we report the latest technology news, interview leaders in the field, and file dispatches from medical events around the world since 2004.

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HealthChampion Digital Platform at CES 2020 https://bhsconnect.net/healthchampion-digital-platform-at-ces-2020/ Tue, 14 Jan 2020 14:09:39 +0000 https://bhsconnect.net/healthchampion-digital-platform-at-ces-2020/ January 14th, 2020 Medgadget Editors Exclusive, Informatics Though CES in Las Vegas is an annual show of the latest gadgetry that companies around the world have been developing, there are also other players that are trying to make an impact in their own ways. We ran into one of the co-founders of HealthChampion, a Chicago-based...

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Though CES in Las Vegas is an annual show of the latest gadgetry that companies around the world have been developing, there are also other players that are trying to make an impact in their own ways.

We ran into one of the co-founders of HealthChampion, a Chicago-based digital health platform that is working on making medical data easily accessible to patients and clinicians and useful to improve outcomes, achieve cost savings, and lead to a more well-rounded healthcare system.

Here’s Reynaldo Villar pitching his company’s offerings and what it intends to do with medically relevant data:

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Link: HealthChampion homepage…

Medgadget Editors

Medical technologies transform the world! Join us and see the progress in real time. At Medgadget, we report the latest technology news, interview leaders in the field, and file dispatches from medical events around the world since 2004.

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InterStim Micro Neurostimulator and SureScan MRI Leads Cleared in Europe for Incontinence Control https://bhsconnect.net/interstim-micro-neurostimulator-and-surescan-mri-leads-cleared-in-europe-for-incontinence-control/ Mon, 13 Jan 2020 17:27:00 +0000 https://bhsconnect.net/interstim-micro-neurostimulator-and-surescan-mri-leads-cleared-in-europe-for-incontinence-control/ Medtronic won EU regulatory clearance to introduce its InterStim Micro neurostimulator and InterStim SureScan MRI leads. The devices are used to deliver sacral neuromodulation therapy to treat overactive bladder (OAB), fecal incontinence, and non-obstructive urinary retention. The InterStim Micro is a much tinier version of Medtronic’s InterStim II neuromodulator, as it is 80% smaller, but...

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Medtronic won EU regulatory clearance to introduce its InterStim Micro neurostimulator and InterStim SureScan MRI leads. The devices are used to deliver sacral neuromodulation therapy to treat overactive bladder (OAB), fecal incontinence, and non-obstructive urinary retention.

The InterStim Micro is a much tinier version of Medtronic’s InterStim II neuromodulator, as it is 80% smaller, but it is a rechargeable device with an expected longevity of about 15 years. This is made possible partially thanks to so-called Overdrive technology that lets the battery maintain almost its full capacity to recharge throughout its working life.

The SureScan MRI leads that come with the InterStim Micro, and which will also be available with the InterStim II, will let patients with the implants to continue to receive MRI (both 1.5 and 3 Tesla) scans as necessary, given certain precautions are taken.

“Effective long-term bladder and bowel control is an under-met medical need for many who experience regular accidents and/or frequency issues associated with OAB and FI,” said Philip E.V. Van Kerrebroeck, M.D., Ph.D., MMSc; professor of Urology, Maastricht University Medical Centre, the Netherlands, in a Medtronic press release. “The new capabilities offered by MRI-conditional InterStim II and InterStim Micro will give patients the ability to choose a system that is compatible with their lifestyle, and they can have an MRI without being explanted. I’m excited because it allows me to offer the trusted experience and support of Medtronic to help give my patients their lives back.”

“We’re excited our most recent technology advances in sacral neuromodulation will allow physicians to treat more patients who need relief from their symptoms,” said Brooke Story, VP and general manager of the Pelvic Health and Gastric Therapies business, part of Medtronic’s Restorative Therapies Group. “We pioneered this therapy 25 years ago in partnership with physicians, and we have the only five-year data for all indications to demonstrate its safety and efficacy. We know from deep experience that it’s important the therapy accommodates the lifestyle of the patient to produce the best outcome, and our latest innovations will now offer them a lifestyle-friendly choice in Medtronic SNM systems.”

Link: Medtronic’s sacral neuromodulation systems…

Flashbacks: Medtronic’s Tiny New InterStim Micro Neurostimulator Submitted to FDA; InterStim Incontinence and Bladder Control Implant Now Controlled via App; InterStim II System for Sacral Nerve Stimulation; Medtronic’s InterStim Therapy Continues to Show Encouraging Results at 3-Year Follow Up; InterStim Sacral Nerve Stimulation for Bowel Control Is Now Option in US; Medtronic’s Verify Sacral Neuromodulation Trial System FDA Approved for Basic Evaluations of Bladder, Bowel Control

Via: Medtronic

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Bioness StimRouter Cleared in Europe to Treat Fecal Incontinence https://bhsconnect.net/bioness-stimrouter-cleared-in-europe-to-treat-fecal-incontinence/ Wed, 08 Jan 2020 18:15:39 +0000 https://bhsconnect.net/bioness-stimrouter-cleared-in-europe-to-treat-fecal-incontinence/ January 8th, 2020 Medgadget Editors GI, Neurology, Neurosurgery Bioness, a Valencia, California firm, won European regulatory approval for its StimRouter neuromodulation system to treat fecal incontinence. Previously cleared in the EU as a tool for managing chronic pain and overactive bladder, the new indication significantly expands the stated capabilities of this novel neuromodulation system. For...

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Bioness, a Valencia, California firm, won European regulatory approval for its StimRouter neuromodulation system to treat fecal incontinence.

Previously cleared in the EU as a tool for managing chronic pain and overactive bladder, the new indication significantly expands the stated capabilities of this novel neuromodulation system.

For the management of fecal incontinence, the StimRouter system targets the tibial nerve near the ankle. This is achieved thanks to a tiny implant and an external pulse transmitter patch that’s stuck to the skin over where the electronic lead implant is positioned. The entire outpatient procedure takes about thirty minutes to complete and relies on local anesthesia.

“The StimRouter for fecal incontinence is a minimally invasive, relatively easy implant that places the lead electrodes next to the Nervus Tibialis,” said Dr. Concha Perez, Hospital Universitario de la Princesa, Madrid, in a Bioness press release. “The patient we implanted, referred from Dr. Cecilio Santander, a gastroenterologist, shows an important, significant improvement in the patient’s QoL with a more than 90% event free life.”

The patient is sent home with a remote control that allows for adjustments to the amount of neuromodulation that is administered by the StimRouter. This allows the physician to program the device, but the patient to still have control over the needed stimulation levels.

Check out our in-depth coverage of the experience from the first StimRouter implants in patients in Canada.

Flashbacks: StimRouter Receives Health Canada Approval: Interview with Mark Geiger of Bioness; Experiences from the First StimRouter Implanted in Patients in Canada; Bioness StimRouter Minimally Invasive Peripheral Nerve Stimulation System

Product page: StimRouter

Via: Bioness

Medgadget Editors

Medical technologies transform the world! Join us and see the progress in real time. At Medgadget, we report the latest technology news, interview leaders in the field, and file dispatches from medical events around the world since 2004.

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SmartCuffs Bring Blood Flow Restriction Training to Consumers https://bhsconnect.net/smartcuffs-bring-blood-flow-restriction-training-to-consumers/ Tue, 07 Jan 2020 17:54:25 +0000 https://bhsconnect.net/smartcuffs-bring-blood-flow-restriction-training-to-consumers/ January 7th, 2020 Medgadget Editors Rehab, Sports Medicine CES 2020, the world’s premier gadget show, just kicked off in Las Vegas. A great number of products will be presented that deal with health and medicine, and we have a reporter on site who will be bringing exclusives from the show floor. One company presenting this...

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CES 2020, the world’s premier gadget show, just kicked off in Las Vegas. A great number of products will be presented that deal with health and medicine, and we have a reporter on site who will be bringing exclusives from the show floor.

One company presenting this year is SmartTools, based outside of Cleveland, Ohio, which is launching new blood flow restriction (BFR) cuffs for athletes and extreme fitness buffs. BFR is used in rehab facilities to minimize loss of muscle mass, so there’s serious interest for people to try the same to help maximize muscle mass for enhanced athleticism.

The SmartCuffs are placed on the upper arm or around the thigh, and can be tuned to the individual’s preferred training regimen. They feature an automated pump that does not require manual pumping to achieve proper pressure, as with previous models of the device. A safety mechanism prevents pressures from exceeding preset levels, so that one won’t cause a serious health issue.

“As the fitness industry continues to grow rapidly, so does the demand for new and innovative training tools,” said Nicholas Colosi, founder of SmartTools, in a press release. “We see tremendous value in introducing these consumer friendly cuffs to the public, and are excited to expand the reach of BFR beyond clinical, and educate the fitness community on the safety and benefits of this technique.”

Product page: SmartCuffs

Via: SmartTools

Medgadget Editors

Medical technologies transform the world! Join us and see the progress in real time. At Medgadget, we report the latest technology news, interview leaders in the field, and file dispatches from medical events around the world since 2004.

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