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Source: Mass Device
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Total 467 results found since Jan 2013.
Silk Road Medical raises $47m
Silk Road Medical said today it raised $47 million in a new funding round to support its Enroute products designed for transcarotid artery revascularization procedures.
The round was led by newly invested Norwest Venture Partners and Janus Capital Management funds and joined by existing investors Warburg Pincus, The Vertical Group and CRG, the Sunnyvale, Calif.-based company said.
Silk Road’s Enroute neuroprotection system is designed to allow physicians direct access to the common carotid artery in the neck to initiate high rate temporary blood flow reversal to protect the brain from stroke during implantations of ...
Source: Mass Device - July 18, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Vascular Silk Road Medical Inc. Source Type: news
Claret Medical raises $11m
Claret Medical has raised $11.2 million in a new round of equity financing, according to an SEC filing posted this week.
Money in the round came from 34 unnamed investors, according to the SEC filing, with the 1st sale dated on June 22.
Claret Medical is still looking to raise an additional $6.5 million in the round, according to the SEC filing. The company has not yet stated how it intends to use funds raised in the round.
The Santa Rosa, Calif.-based company produces the Sentinel embolic protection device designed to trap blood clots and prevent stroke during heart valve replacement procedures.
The Sentinel device uses a...
Source: Mass Device - July 17, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Claret Medical Inc. Source Type: news
Cardiac Insight launches Cardea Solo wearable AF sensor
Cardiac Insight said today it launched its Cardea Solo electrocardiogram sensor designed for diagnosing atrial fibrillation following cardiac ablation.
The Cardea Solo device is designed to provide both physicians and patients with cardiac data and help diagnose a variety of arrhythmias including atrial fibrillation, the Kirkland, Wash.-based company said.
The Cardea Solo sensor is a lightweight, leadless, water resistant single-use disposable designed to record ECG data and patient symptoms.. The device can be worn under clothing for up to 7 days, the company said.
“Cardiac Insight’s Cardea Solo is a game changer...
Source: Mass Device - July 11, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Cardiovascular Patient Monitoring Cardiac Insight Source Type: news
Penumbra picks up Italian distributor Crossmed for $9m
Penumbra (NYSE:PEN) said today it paid $9.4 million (EU €8.2 million) for all outstanding shares of Italian Crossmed S.p.a., which operated as the company’s exclusive distributor in Italy, San Marino and the Vatican.
Alameda, Calif.-based Penumbra said that with the acquisition, Crossmed is now a wholly-owned subsidiary of the company. Penumbra added that there are no material relationships between it and any of the sellers other than those pertaining to the acquisition.
In addition to the initial payment, Penumbra said that it will also pay additional milestone payments based on Crossmed’s net revenue, &#...
Source: Mass Device - July 11, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Distribution Mergers & Acquisitions Penumbra Inc. Source Type: news
ReWalk Robotics inks French distro deal with Harmonie M édical Service
ReWalk Robotics (NSDQ:RWLK) said today it inked an exclusive French distribution deal with Harmonie Médical Service.
Through the deal, HMS will operate as sole distributor of the ReWalk exoskeleton systems for individuals with spinal cord injuries in France. The deal includes both the ReWalk Personal and ReWalk Rehabilitation systems for home and clinical use, respectively.
“Our partnership with ReWalk is a real opportunity for HMS. We have been working for 30 years in the medical materials domain with people who have lost their mobility. We have always looked for innovative technologies in this domain, especially...
Source: Mass Device - July 11, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Distribution Robotics ReWalk Robotics Source Type: news
FDA clears Medtronic ’ s CoreValve Evolut TAVR in intermediate risk patients
Medtronic (NYSE:MDT) said today it won expanded FDA approval for its CoreValve Evolut transcather aortic valve replacement platform, now indicated for patients with symptomatic severe aortic stenosis who are at an intermediate risk for open heart surgery.
The Fridley, Minn.-based company said that patients at intermediate risk for open-heart surgery have a mortality risk of greater than or equal to 3% at 30 days following the procedure.
“Patients at intermediate risk for open-heart surgery account for a large portion of the severe aortic stenosis population. We are delighted to take the self-expanding CoreValve Evo...
Source: Mass Device - July 10, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Food & Drug Administration (FDA) Regulatory/Compliance Replacement Heart Valves Medtronic Source Type: news
Cardiologs wins FDA 510(k) for ECG analysis platform
Cardiologs Technologies said today it won FDA 510(k) clearance for its Cardiologs ECG analysis platform designed to aid in the screening for atrial fibrillation and other arrhythmias.
The platform is a cloud-based cardiac monitoring and analysis web service which uses artificial intelligence to analyze long-term ambulatory ECG monitoring recordings, the Paris-based company said. The system already has CE Mark approval in the European Union, the company added.
“It is intuitive that screening for AFib and subsequent anticoagulant treatment should reduce the stroke burden, which is the basis of guideline recommendations...
Source: Mass Device - July 6, 2017 Category: Medical Devices Authors: Fink Densford Tags: 510(k) Cardiovascular Food & Drug Administration (FDA) Regulatory/Compliance cardiologstechnologies Source Type: news
FDA updates on Baxter Vascu-Guard patch recall
The FDA today released an update on Baxter‘s (NYSE:BAX) voluntary recall of its Vascu-Guard peripheral vascular patch, saying that it is working with the company but that neither group has discovered a root cause for the issues, which led to a number of adverse events and 3 potential patient deaths.
The Vascu-Guard patch is designed for use in vascular reconstruction surgeries including carotid, renal, iliac, femoral, profund and tibial blood vessels and arteriovenous access revisions, the FDA said.
While the federal watchdog said it has yet to discover the cause of the issue, it did offer that so far, there have bee...
Source: Mass Device - July 6, 2017 Category: Medical Devices Authors: Fink Densford Tags: Food & Drug Administration (FDA) Recalls Vascular Baxter Source Type: news
Myomo touts reduced upper extremity impairment in MyoPro trial
This study is an important milestone supporting Myomo’s growing commercialization efforts. It clearly demonstrates the functional value of the MyoPro orthosis and how it meets a medical necessity. It provides useful information for clinicians who recommend and prescribe the device, as well as for payers. This is the first of several clinical studies that are underway that the company expects to see published over the coming months and years,” CEO & chair Paul Gudonis said in a prepared statement.
Earlier this month, Myomo said it launched its next-generation MyoPro 2 myoelectric arm orthosis designed to restore...
Source: Mass Device - June 30, 2017 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Prosthetics Myomo Inc Source Type: news
eLum Tech raises $4m in Series A
Early stage medical device developer eLum Technologies said today it raised $3.5 million in a Series A financing round, and an additional $810,000 in notes with private early stage investors.
Funding in the round will aid in the development of the company’s device designed for stroke therapy, though the company has not yet released details of the device or other developments.
“This additional funding will enable us to bolster the current infrastructure for our product development and build on the results we have achieved to date. We received positive responses regarding our technology, and have a skilled team i...
Source: Mass Device - June 26, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News elumtechnologies Source Type: news
Report: New MRI technique improves brain scan accuracy
A new MRI technique could allow physicians to more accurately examine brain scans, according to an MIT News report.
Researchers at MIT, working with physicians at Massachusetts General Hospital and other institutions, have developed a way to boost the quality of the brain scans so that they can be used for large-scale studies on the effects of stroke and treatment responses, according to the report.
The scans could help researchers discover how genetic factors influence stroke survival, as well as serving as a new approach to understanding disorders such as Alzheimers, MIT News reported.
The new scanning approach involves ...
Source: Mass Device - June 22, 2017 Category: Medical Devices Authors: Fink Densford Tags: Imaging Neurological Source Type: news
Philips picks up EEG dev Electrical Geodesics for $37m
Royal Philips (NYSE:PHG) said today it has agreed to acquire Electrical Geodesics for $36.7 million (GBP£ 29 million).
Amsterdam-based Philips said that EGI’s portfolio of EEG hardware, software and acquisition sensors would work to complement its existing imaging tech and advanced informatics portfolio for neurological applications.
In the sale, Philips is offering $133.50 (GBP £105.40) for each EGI share, constituting a 36% premium to its June 21 closing value, the company said. The transaction is subject to customary closing conditions and stockholder approval, with a slated completion date in the 3rd quarter ...
Source: Mass Device - June 22, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Imaging Mergers & Acquisitions royal-philips Source Type: news
ReWalk debuts Restore soft-suit exoskeleton prototype
ReWalk Robotics (NSDQ:RWLK) today debuted the prototype of its Restore soft suit exoskeleton designed to aid stroke survivors.
The company presented the prototype alongside collaborators from Harvard University’s Wyss Institute for Biologically Inspirde Engineering, and said it would focus on the suit as a “core company goal” for the fiscal year.
“We are thrilled with the progress of the Restore system, which will provide life changing technology to a whole new class of patients facing mobility issues. With the prototype finished, we are eager to begin clinical studies and pursue regulatory approva...
Source: Mass Device - June 19, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Robotics ReWalk Robotics Source Type: news
MassDevice.com +5 | The top 5 medtech stories for June 12, 2017
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.
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5. MassDevice Q&A: Claret Medical’s Azin Parhizgar on trying to make TAVR safer
Cerebral protection developer Claret Medical recently won FDA de novo clearance for its Sentinel device designed to trap blood clots and prevent...
Source: Mass Device - June 12, 2017 Category: Medical Devices Authors: MassDevice Tags: News Well Plus 5 Source Type: news
MassDevice Q & A: Claret Medical ’ s Azin Parhizgar on trying to make TAVR safer
Cerebral protection developer Claret Medical recently won FDA de novo clearance for its Sentinel device designed to trap blood clots and prevent stroke during heart valve replacement procedures.
The Sentinel uses a pair of filters, 1 in the brachiocephalic artery another in the left common carotid artery, to trap debris released during transcatheter aortic valve replacement that could cause a cerebral embolism.
The device has seen a rough road to approval, however, after missing the primary efficacy endpoint in its pivotal trial. Despite that, the device saw nearly unanimous support from an FDA advisory panel and was c...
Source: Mass Device - June 12, 2017 Category: Medical Devices Authors: Fink Densford Tags: Neurological Surgical Vascular Claret Medical Inc. Source Type: news
