Filtered By:
Source: Mass Device
This page shows you your search results in order of date. This is page number 5.
Order by Relevance | Date
Total 467 results found since Jan 2013.
FDA warns of high stroke, mortality risk with SynCardia TAH-t C2 controller
The FDA on Friday released a letter warning of a higher mortality risk and stroke rate than expected for patients receiving treatment from SynCardia Systems’ Temporary Total Artificial Heart Companion 2 Driver System.
Data indicating the higher mortality and stroke rate came from a post-approval study conducted by the company itself, the FDA said. The study indicated that patients treated with the previous generation driver of the device, the Circulatory Support System Console, experienced a lower rate of stroke and mortality compared with the C2.
The TAH-t system is designed to function as a bridge to a heart transplant...
Source: Mass Device - August 20, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Clinical Trials Food & Drug Administration (FDA) SynCardia Source Type: news
J & J ’ s Cerenovus wins CE Mark for Bravo flow diverter
Johnson & Johnson‘s (NYSE:JNJ) Cerenovus said this week it won CE Mark approval in the European Union for its Bravo flow diverter designed to treat intracranial aneurysms.
The newly cleared device is designed to divert blood flow from aneurysms to promote healing and reduce the risk of rupture, the company said. The Bravo is Cerenovus’ first flow diverter device, the company added.
“Flow diverters are now widely used and for many, have become the go to option for the treatment of complex aneurysms. I believe the design of the Bravo flow diverter, particularly the proximal and distal expansion rings, pro...
Source: Mass Device - August 10, 2018 Category: Medical Devices Authors: Fink Densford Tags: Neurological Regulatory/Compliance Vascular cerenovus johnsonandjohnson Source Type: news
Boston Scientific closes $270m Claret Medical buy
Boston Scientific (NYSE:BSX) said yesterday that it closed the $270 million buyout of Claret Medical and its Sentinel device, including a $50 million earnout pegged to a reimbursement win that just came in.
Claret’s Sentinel device is designed to trap and remove debris dislodged during transcatheter aortic valve replacements to prevent stroke and other neurological damage. The deal, announced July 20, originally called for an up-front cash payment of $220 million plus the $50 million reimbursement milestone.
That milestone was reached when the Centers for Medicare & Medicaid Services granted a New Technology Add...
Source: Mass Device - August 3, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Mergers & Acquisitions Replacement Heart Valves Wall Street Beat Boston Scientific Claret Medical Inc. Source Type: news
Rapid Medical wins CE Mark for Tigertriever 13 stent retriever
Neurovascular device maker Rapid Medical said it won CE Mark approval in the European Union for its Tigertriever 13 stent retriever intended for treating ischemic stroke, and added that the first patient in the region has been treated with the device.
The Israel-based company touted the Tigertriever 13 as the first-ever fully-visible stent retriever that can be adjusted by the physician to fit in the dimensions of the blocked blood vessel.
Rapid Medical said that the device’s profile is 83% smaller than any other devices on the market, and that it is designed to recanalyze intracranial vessels of between 1mm and 2....
Source: Mass Device - July 31, 2018 Category: Medical Devices Authors: Fink Densford Tags: Regulatory/Compliance Vascular rapidmedical Source Type: news
Boston Scientific puts $270m on the table for Claret Medical
Boston Scientific (NYSE:BSX) said today that it agreed to pay as much as $270 million to acquire Claret and its Sentinel device.
Marlborough, Mass.-based Boston Scientific said the deal involves an ip-front cash payment of $220 million and another $50 million pegged to a reimbursement milestone. Claret’s Sentinel device is designed to trap and remove debris dislodged during transcatheter aortic valve replacements to prevent stroke and other neurological damage.
After landing CE Mark approval in the European Union in 2014, Santa Rosa, Calif.-based Claret won de novo clearance from the FDA last year for the Sentinel d...
Source: Mass Device - July 20, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Mergers & Acquisitions Replacement Heart Valves Wall Street Beat Boston Scientific Claret Medical Inc. Source Type: news
Google joins $21m Series A for Viz.ai
Artificial Intelligence healthcare developer Viz.ai has raised $21 million in a Series A funding round joined by GV, formerly known as Google Ventures.
The round was led by Kleiner Perkins, the San Francisco-based company said. In connection with the funding round, Kleiner Perkins general partner Mamoon Hamid will join the company’s board of directors.
“We were attracted not only to the technology behind Viz.ai and its impact on patient outcomes, but also its adoption model. Many new health-tech solutions struggle to gain traction because they are an outside-in sale to medical teams, requiring changes to proc...
Source: Mass Device - July 19, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Funding Roundup vizai Source Type: news
NIH director Collins touts AF detection capabilities of iRhythm ’ s Zio ECG patch
iRhythm Technologies‘ Zio ECG patch won praises from NIH Director Dr. Francis Collins this week for its ability to aid in the detection of atrial fibrillation.
In an NIH Director blog post, Dr. Collins warned that while the dangers of atrial fibrillation are known, many individuals do not know they have atrial fibrillation and therefore cannot receive appropriate care.
While doctors mainly screen for AFib by checking pulse, Dr. Collins recommended new mobile health technologies for detecting AF, including iRhythm’s Zio patch.
Results from the mSToPS trial of the patch, which Dr. Collins referenced, indicated that t...
Source: Mass Device - July 18, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Cardiovascular iRhythm Technologies Inc. Source Type: news
Stryker wins FDA approval for Surpass Streamline brain aneurysm device
Stryker (NYSE:SYK) said today that it won pre-market approval from the FDA for its Surpass Streamline flow diverter for treating certain types of brain aneurysm.
Kalamazoo, Mich.-based Stryker said the PMA covers the treatment of un-ruptured large and giant wide-neck aneurysms. It’s the second flow diverter to be approved for the U.S. market, after Medtronic (NYSE:MDT) won a nod from the federal safety watchdog for its Pipeline Flex device in 2015.
“The PMA approval of Surpass Streamline flow diverter in the U.S. is an important milestone for the division. It expands our commercial footprint into the flow di...
Source: Mass Device - July 16, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Neurological Regulatory/Compliance Wall Street Beat Stryker Source Type: news
Medtronic wins FDA nod for thoracotomy-based HVAD procedure
Medtronic (NYSE:MDT) said today it won FDA approval for thoracotomy-based implantation procedures with its HVAD left ventricular assist device, which it said is a less-invasive implantation approach.
The Fridley, Minn.-based medtech giant touted the approval as the first for any commercially available LVAD in the US, and said that the clearance came based on data from the Lateral clinical trial of the device.
The 44-patient trial met its primary endpoint of non-inferiority, with data indicating an 88.1% rate of survival at six months free from disabling stroke or device explant or exchange due to malfunction. Results also...
Source: Mass Device - July 11, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Food & Drug Administration (FDA) Regulatory/Compliance Medtronic Source Type: news
Medline buys Canadian stroke rehab device maker NeuroGym
Medline has acquired physical therapy and rehabilitation equipment maker NeuroGym Technologies of Ottawa.
NeuroGym’s equipment is designed for people who have had a stroke or other traumatic brain injury, spinal cord injury, chronic neurological conditions such as multiple sclerosis, balance issues and/or the need for fall prevention therapy.
The equipment requires the patient to initiate movement, which the company says can help rewire the brain and speed recovery. It includes a sit-to-stand trainer, bungee mobility trainer to re-teach walking and improve balance, a pendulum stepper for lower extremity strength and r...
Source: Mass Device - July 11, 2018 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Source Type: news
Dynatronics taps ex-NinePoint CEO von Jako as chief exec | Personnel Moves – July 11, 2018
Dynatronics said late last month it tapped former NinePoint Medical CEO Christopher von Jako as its new chief executive officer and board member, succeeding Kelvyn Cullimore Jr. who will stay on the company’s board of directors.
Prior to joining Dynatronics, von Jako acted as prez & CEO of NinePoint Medical. Before joining Nine Point, von Jako also served as prez & CEO of NeuroTherm, prez of ActiViews and held positions with medtech companies including Integra LifeSciences, Covidien and Medtronic.
“After thorough succession planning and a comprehensive search process, the board is pleased to have foun...
Source: Mass Device - July 11, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News AngioDynamics berkshiresterilemanufacturing Corindus Vascular Robotics Dynatronics Corp Guerbet integer MedPlast Medtronic Myomo Inc NinePoint Medical Inc. Pavmed viant Source Type: news
Gore touts first use of Tag conformable thoracic stent graft in Australia
W.L. Gore & Associates said yesterday that it launched its Gore Tag conformable thoracic stent graft with active control in Australia, touting that the first procedures with the device have been performed in the region.
The first implant procedures with the device were performed by Dr. Ian Spark of Adelaide, Australia’s Flinders Medical Centre, Gore said.
“The Gore Tag conformable stent graft is a reliable and trusted device that I have used for TEVAR procedures with my patients for many years. The availability of the new Gore Active Control System is an exciting advancement because it significantly enhanc...
Source: Mass Device - July 3, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Stent Grafts Vascular W.L. Gore & Associates Source Type: news
ReWalk Robotics amends soft exoskeleton research, licensing deal with Harvard
UPDATE: Corrected to reflect that ReWalk Robotics was amending an earlier deal.
ReWalk Robotics (NSDQ:RWLK) has inked a set of amendments to its collaborative research and exclusive licensing agreement with Harvard Collage related to the development of its soft-suit exoskeleton, according to a recently posted SEC filing.
Through the original collaborative deal, both groups will join to aid in the development of soft-suit exoskeleton technologies designed to treat lower limb disabilities, the Marlborough, Mass.-based company said. The suit is intended to treat stroke, multiple sclerosis, mobility limitations for the elderl...
Source: Mass Device - July 2, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Research & Development Robotics ReWalk Robotics Source Type: news
Clot-buster captures tiny particles, too
MIVI Neuroscience’s next-generation DAISe blood clot management system has had its first-in-human use for treatment of ischemic stroke.
The procedure took place in South America, the company said in a statement. DAISe is designed to remove a clot as well as filter and capture clot emboli that fracture during removal. It has a three-dimensional, vessel-conforming meshwork of hundreds of polymeric fibers that act as a mechanical backstop to capture debris as small as 40 um while maintaining blood flow through the device. Device delivery is similar to that of a stent retriever.
Get the full story on our sister site, Medi...
Source: Mass Device - July 2, 2018 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Cardiovascular Research & Development MIVI Neuroscience Source Type: news
Neurologic-focused digital therapeutics group MedRhythms raises $5m
Early stage medtech company MedRhythms said today it raised $5.3 million in a Series A round of financing to help support its platform intended to use neurologic interventions to measure and improve walking.
The Portland, Maine-based company said it initially intended to raise $4 million, but found “substantial interest” and ended up netting extra funds. MedRhythms added that it has already closed $5 million from the round.
Funds will support continued development and a potential launch of MedRhythm’s digital therapeutics platform intended to aid individuals with neurologic injuries and diseases and impro...
Source: Mass Device - June 29, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Funding Roundup Neurological medrhythms Source Type: news
