Biotronik wins FDA nod for Orsiro DES

Biotronik logo

Biotronik said today that it won FDA approval for its for its Orsiro drug-eluting stent, touting it as the first and only ultrathin DES to outperform Abbott‘s (NYSE:ABT) Xience.

The Berlin, Germany-based company said that the approval came based on data from the BIOFLOW-V pivotal trial of the device. Results from the study indicated a significantly lower rate for target lesion failure and target vessel myocardial infarction at 12 months as compared to Xience in a large, complex patient audience.

Read the whole story on our sister site, Drug Delivery Business News

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Axonics wins expanded MRI-safe CE Mark approval for r-SNM system

Axonics Modulation Technologies

Axonics Modulation Technologies (NSDQ:AXNX) said today that it won expanded CE Mark approval clearing its r-SNM Sacral Neuromodulation system for use with 1.5T and 3T full body magnetic resonance imaging.

The Irvine, Calif.-based company touted the r-SNM as the only implantable SNM system to have received full-body labeling in the EU.

“Without this labeling, any patient requiring an MRI scan on any body part below the head must have their neurostimulator surgically explanted prior to the MRI scan, resulting in an additional surgery for the patient and additional costs to patients and the healthcare system. This authorization of full-body MRI scans in Europe is another important milestone for Axonics, differentiating our technology from the competitive system and further demonstrating the foresight of our engineers and our commitment to invest the time and capital to provide the best possible SNM solution for patients, clinicians and the healthcare system. As announced on February 12, Axonics submitted complete test data to the U.S. FDA for the purpose of gaining Conditional Full Body Magnetic Resonance Imaging labeling approval in the U.S,” CEO Raymond Cohen said in a prepared statement.

“This is a game changer. Full-body MRI labeling is critical to patients who need, or may anticipate needing, magnetic resonance imaging. This new expanded labeling eliminates a major concern for both groups of patients and will allow more patients to choose SNM to treat their urinary and bowel dysfunction without compromising their quality of life,” chief medical officer Dr. Karen Noblett said in a press release.

Earlier this month, Axonics said that it submitted an amendment to the FDA premarket approval application for its implantable r-SNM System 1 Sacral Neuromodulation device seeking full-body magnetic resonance imaging labeling.

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FDA releases brain-computer interface draft guidance


The FDA today released draft guidance for brain-computer interface devices, an emerging novel technology that allows users direct control of devices.

Brain-computer interface devices, which are currently all experimental, allow direct control of devices and are often used to control limb prostheses. The experimental systems have the potential to significantly aid individuals with severe disabilities and increase their level of interaction with the environment, the FDA said.

The federal watchdog said it recently held a public workshop focused on BCI devices which defined them as “neuroprostheses that interface with the central or peripheral nervous system to restore lost motor or sensory capabilities.”

The FDA said that a result of the workshop was the initiation of the draft guidance, which will be open to public comment as it is finalized.

FDA head Dr. Scott Gottlieb said that the draft guidance is considered a “leap-frog” guidance intended to help bridge current technology with future innovations.

The newly released guidance provides proposed recommendations for developers on what non-clinical testing and clinics study design could be used for developing BCI devices for patients with paralysis or amputations, and includes detailed technical advice and study design recommendations.

The FDA said that the guidance proposes that non-clinical device testing can be used to demonstrate mitigation of potential risks prior to clinical testing.

“Proper design of clinical trials is essential to provide reasonable assurance of safety and effectiveness to support a regulatory submission to the FDA,” Gottlieb wrote in the release.

The FDA said that it has also developed the Emerging Sciences Working Group, a team of 15 experts charged with conducting long-range horizon scanning and reporting back on emerging issues and new scientific advances.

In late 2017, researchers at Battelle  touted that the 1st user of its experimental NeuroLife system, a BCI system designed to restore upper body mobility control to paralyzed patients through mental control, has shown improved control smoothness and accuracy with the system.

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ViewRay wins FDA nod for MRIdian system soft tissue visualization capabilities


ViewRay (NSDQ:VRAY)  said yesterday that it won FDA 510(k) clearance to offer soft tissue visualization capabilities with its MRIdian system.

The newly cleared features include expanded high-definition visualization and contrast between tissues, diffusion weighted imaging for improved distinguishing between normal and tumor tissues and more detailed, brighter and faster anatomical planar imaging, the Cleveland-based company said.

“Today we announce another significant step forward in our drive to better treat cancer patients and further differentiate MRIdian in the marketplace. Our customers are seeking significant improvements on imaging speed, resolution and brightness. They also demand that we avoid artifacts and distortions that have historically and consistently plagued the field. We believe these innovations hit the mark. We will continue to advance the field of MR Guided Radiation Therapy and expand the application of the MRIdian system,” founder & chief scientific officer James Dempsey said in a press release.

Last August, ViewRay said that it closed a $172.5 million offering with funds slated to support working capital and general corporate purposes.

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ARS Pharmaceuticals wins fast track status for epinephrine nasal spray

ARS PharmaceuticalsARS Pharmaceuticals said this week that it won fast track status from the FDA for its investigational intranasal epinephrine spray, ARS-1.

The San Diego, Calif.-based company’s device is designed to be an easy-to-use treatment for people suffering from severe allergic reactions to food, drugs and insect bites.

Get the full story at our sister site, Drug Delivery Business News.

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Philips wins FDA nod for DigitalDiagnost C90 digital radiography system


Philips (NYSE:PHG) said yesterday that it won FDA 510(k) clearance for its DigitalDiagnost C90 digital radiography system.

The Amsterdam-based company said that the DigitalDiagnost C90 includes a live camera image displayed directly at the tube head to provide a clear view of the anatomical area being scanned during positioning.

The newly cleared system also incorporates Philips Eleva user interface intended to improve workflows, the company said.

“In today’s world of value-based care, healthcare organizations are investing in imaging solutions that help them achieve the quadruple aim: improved outcomes, enhanced patient experience, increased staff satisfaction and lowered cost of care delivery. With solutions like the DigitalDiagnost C90, Philips is helping radiology departments get one step closer to achieving that ambition through innovation that enables higher quality images, while keeping the patient and staff experience at the forefront,” diagnostic X-ray business leader Daan van Manen said in a press release.

Earlier this month, Philips said that it launched its new Epiq Elite ultrasound system.

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Hygieia wins FDA clearance for insulin management app

Hygieia logo - smallHygieia said today that it won 510(k) clearance from the FDA for its insulin management app designed to optimize insulin dosing among people with Type 2 diabetes.

The Michigan-based company touted its product as the first insulin management mobile app that can titrate individualized doses for all types of insulin regimens.

Get the full story at our sister site, Drug Delivery Business News.

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Edwards Lifesciences wins CE Mark for Pascal mitral repair device

Edwards Lifesciences

Edwards Lifesciences (NYSE:EW) said late yesterday that it won CE Mark approval in the European Union for its Pascal transcatheter valve repair system intended to treat mitral regurgitation.

The Pascal system is designed to reduce mitral regurgitation while maintaining native anatomy and features contoured, broad paddles to maximize coaptation of the mitral leaflets and a central spacer to fill the regurgitant orifice area, the Irvine, Calif.-based company said.

The newly launched system also includes a delivery system intended for independent leaflet capture to optimize leaflet position, Edwards said.

“Mitral valve disease is complex, varied and prevalent, and patients are in significant need of multiple safe and effective therapies to treat debilitating symptoms that can lead to a high rate of mortality. The introduction of the Pascal system to clinicians and patients in Europe provides a differentiated, minimally-invasive therapy to address the needs of patients with mitral regurgitation,” transcatheter mitral and tricuspid therapies corp VP Bernard Zovighian said in a press release.

Edwards said that is engaged in a U.S. pivotal trial of the device, the CLASP IID study, which it hopes will support eventual FDA clearance of the system.

“The Pascal system is uniquely designed for optimized valve leaflet capture and coaptation, and to help operators achieve their ultimate goal of safe and effective mitral regurgitation reduction for their patients,” CLASP sutdy investigator Konstantinos Spargias of Greece’s Hygeia Hospital said in a prepared statement.

Last week, Edwards said that it inked a deal to acquire CAS Medical System (NSDQ:CASM) and its non-invasive brain tissue oxygenation monitoring tech for approximately $100 million.

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AdvaMed president & CEO Scott Whitaker to participate in keynote interview at DeviceTalks Boston 2019

DeviceTalks Boston 2019 - Scott WhitakerWTWH Media and announced today that Scott Whitaker, president and CEO of AdvaMed, will be a featured keynote speaker at DeviceTalks Boston 2019.

DeviceTalks Boston, which takes place on June 5-6, 2019 at the Seaport World Trade Center, brings together engineering, product development and commercialization professionals to share the challenges and best practices of getting medical devices to the market.

“We are very excited that Scott Whitaker will provide the DeviceTalks Boston audience with an inside look at AdvaMed’s priorities for 2019. Scott is a leading voice in the medical device industry, helping to shape the policies that affect every device company. The DeviceTalks team is thrilled that he will join us in June for our eighth year in Boston,” said DeviceTalks content manager Sarah Faulkner.

“It’s a pleasure to be returning to Boston for DeviceTalks in June, and also for The MedTech Conference powered by AdvaMed this September,” Scott Whitaker said. “Boston is at the epicenter of medtech innovation across the region, helping to provide life-changing solutions for patients around the world, and we’re excited to be there.”

Recruiting from the best of Boston’s medtech ecosystem, DeviceTalks Boston highlights speakers who explore how to build better devices and better companies. To register, visit

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NuVasive wins FDA, CE Mark for Precice internal bone transport system


NuVasive Inc. (NSDQ:NUVA) said today that it won FDA 510(k) clearance and CE Mark clearance in the European Union for its Precice bone transport system.

The San Diego, Calif.-based company touted the system as the only all-internal system indicated for use in segmental bone loss treatment in the tibia and femur resulting from trauma or infection.

The Precice bone transport system includes an implantable magnetic intramedullary nail with a dual slot intended to support the transport of an intercalary bone segment to allow for health regeneration, NuVasive said. Following implantation, an external remote control is used to move the bone segment up to 10 centimeters based on patient needs, the company added.

The newly cleared all-internal system does not require patients to wear an external device for an extended period of time, reducing the potential for increased pain and risk of infection, NuVasive said.

“The Precice Bone Transport System enables the treatment of complex segmental defects using the proven, less invasive, Precice magnetic technology which is a game-changer for my practice and patients. Patients who undergo a bone transport procedure due to trauma, tumors or infection are already dealing with significant issues regarding their condition, and the extreme time commitment it takes to reconstruct these significant bone defects. To be able to offer a treatment option that allows them to avoid many of the traditional complications and physical challenges of dealing with an external fixation system that is on their limb for an extended period of time is a significant development,” Dr. J. Watson of the University of Arizona College of Medicine said in a press release.

NuVasive said that it plans to launch the system commercially in the U.S. and Europe in the third quarter of this year.

“The FDA clearance and CE mark approval for use of the Precice Bone Transport System are an exciting step forward for NSO as we continue to demonstrate how our innovative technologies can transform the orthopedic trauma space. With this clearance, we are now able to offer surgeons an all-internal, reliable treatment option that provides a simple approach to salvage both limbs and joints for complex limb reconstructions, such as patients with invasive tumors or large segmental defects. We remain committed to the ongoing development of innovative orthopedic solutions that equip surgeons to fulfill unmet clinical needs and, ultimately, improve the lives of patients,” NuVasive Specialized Orthopedics president Massimo Calafiore said in a prepared statement.

Earlier this month, a report emerged suggesting that Smith & Nephew (NYSE:SNN) is in discussions to pick NuVasive in a deal that could be worth more than $3 billion.

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