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Source: Mass Device
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Total 467 results found since Jan 2013.
Cleveland Clinic, Boston Sci think deep brain stimulation can treat strokes
Illustration of a deep brain stimulation lead implanted in the cerebellar dentate nucleus for treatment of post-stroke motor deficits. [Image from Cleveland Clinic]The Cleveland Clinic is pioneering deep brain stimulation for stroke recovery, with an ongoing clinical trial to determine if Boston Scientific’s Vercise DBS system improves movement in recovering stroke patients.
Dr. Andre Machado and his team performed the 6-hour deep brain stimulation surgery on Dec. 19, 2016. The procedure implanted electrodes into the cerebellum section of the brain. The deep brain stimulation electrodes emit small electric pulses while c...
Source: Mass Device - May 9, 2017 Category: Medical Devices Authors: Danielle Kirsh Tags: Biotech Neuromodulation/Neurostimulation Boston Scientific Cleveland Clinic deep brain stimulation MedTech Source Type: news
Medical imaging AI dev Viz raises $8m in seed round
Medical imaging artificial intelligence company Viz said today it closed a $7.5 million seed round of financing to support the development of its AI platform.
Viz is developing an AI-equipped medical imaging platform with an initial focus on stroke, looking to improve outcomes and treatment of stroke patients by shortening the time between seeking and receiving treatment.
The company’s AI platform is being developed to compare patient scans to thousands of other scans to determine patterns within them, and aid in treatment accuracy and speed.
“As doctors, there is nothing more important to us than improving pat...
Source: Mass Device - May 25, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Imaging Software / IT viz 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
Rapid Medical raises $9m in Series B for neurovascular devices
Neurovascular device maker Rapid Medical said today it closed a $9 million Series B round of financing to support its minimally invasive stroke treatment and prevention devices.
Rapid Medical produces the Tigertriever revascularization device and Comaneci adjustable remodeling mesh designed for neurovascular use, the Israel-based company said.
The company touted the Tigertriever as the only controllable, fully-visible stent retriever which can be adjusted by the physician to fit in the dimensions of the blocked blood vessel and the Comaneci as the 1st-ever controllable, fully-visible aneurysm neck-bridging mesh device whic...
Source: Mass Device - July 18, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Neurological Vascular rapidmedical Source Type: news
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
FDA recalls Penumbra 3D Revascularization device over wire separation issues
The FDA today released a recall notice for Penumbra‘s (NYSE:PEN) 3D Revascularization Device, part of its Penumbra system designed to remove thrombus from brain blood vessels during strokes, over issues with wire breaks and separations.
The FDA labeled the recall as Class I, its most serious designation, indicating that there is a reasonable probability that use of the product could cause serious adverse health consequences or death.
The 3D Revascularization device is designed to restore blood flow or remove blood clots in blood vessels in the brain during acute ischemic stroke in patients who are ineligible or fail...
Source: Mass Device - July 21, 2017 Category: Medical Devices Authors: Fink Densford Tags: Blood Management Food & Drug Administration (FDA) Neurological Recalls Vascular Penumbra Inc. Source Type: news
ESC 2017 Roundup: Biotronik touts lowered mortality for AF patients treated with cath ablation
Biotronik today released results from the Castle-AF study exploring the use of catheter ablation to treat heart failure patients with atrial fibrillation, touting a 38% composite reduction in all-cause mortality and hospitalization for worsening heart failure.
The 398-patient, 33-site study compared the results of catheter ablation treatment for AF in heart failure patients using implantable cardioverter defibrillators or cardiac resynchronization therapy defibrillators to standard-of-care pharmacological therapy, the company said. Biotronik touted it as the largest study of its kind to date.
Results indicated a 47% reduc...
Source: Mass Device - August 28, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Assist Devices Cardiac Implants Cardiovascular Clinical Trials Biotronik Medtronic Source Type: news
Claret Medical raises $21m to support Sentinel system
Claret Medical has raised $21.2 million in a new round of equity financing, according to an SEC filing posted last week.
In a press release posted today, the company said that it raised $14.5 million in a Series C round led by Lightstone Ventures and joined by Easton Capital, HealthCor Partners, Incept and Sante Ventures.
Proceeds are slated to support market access program, next-gen R&D and expanding commercialization to support its Sentinel cerebral protection system.
The Sentinel embolic protection device is designed to trap blood clots and prevent stroke during heart valve replacement procedures, which Claret Medic...
Source: Mass Device - October 23, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Claret Medical Inc. Source Type: news
TCT 2017: Medtronic touts results from 6-month Evolut Pro study
Medtronic (NYSE:MDT) today released six-month data from a study of its Evolut Pro transcatheter aortic valve replacement platform, touting low rates of paravalvular leaks and low rates of all-cause mortality and disabling stroke.
Data came from 60 patients in the trial who received the Evolut Pro valve, and follow previously released 30-day outcomes.
Results at six-months indicated trace or no paravalvular leaks in 88% of patients, with low rates of all-cause mortality and disabling stroke. No instances of coronary obstruction or valve thrombosis were reported and the permanent pacemaker implantation rate was 11.7%, Medt...
Source: Mass Device - November 2, 2017 Category: Medical Devices Authors: Fink Densford Tags: Catheters Clinical Trials Replacement Heart Valves Medtronic Source Type: news
FDA clears AliveCor ’ s KardiaBand ECG for Apple Watch
AliveCor said today that the FDA cleared its KardioBand electrocardiogram device for the Apple Watch, designed to monitor for early signs of atrial fibrillation.
First introduced in March 2016, KardiaBand is the first medical device accessory to be cleared by the federal safety watchdog for the Apple Watch, Mountain View, Calif.-based AliveCor said. It’s designed to display and record clinical-grade cardiac rhythm readings in real time in about 30 seconds, the company said.
AliveCor also said it launched the SmartRhythm artificial intelligence app for the Apple Watch, which is designed to continuously evaluate the ...
Source: Mass Device - November 30, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Patient Monitoring Wall Street Beat AliveCor Cardiac Rhythm Management Source Type: news
NeuroVasc Tech raises $6m in Series B
NeuroVasc Technologies said yesterday it closed a $6.3 million Series B preferred stock round.
The round was joined by multiple investors, and led by ShangBay Capital, the Laguna Hills, Calif.-based company said.
NeuroVasc Tech is developing treatments for neurovascular conditions with a focus on treating ischemic stroke, and currently has CE Mark approval in the European Union for its Versi mechanical thrombectomy system used to remove clots form the brain during acute ischemic stroke.
The device does not yet have FDA clearance for use in the US, the company said.
“NeuroVasc’s technologies may significantly im...
Source: Mass Device - May 17, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Funding Roundup Neurological Vascular NeuroVasc Technologies Source Type: news
J & J ’ s Cerenovus wins FDA nod for Embotrap II revascularization device
Johnson & Johnson‘s (NYSE:JNJ) Cerenovus said today it won FDA 510(k) clearance for the Embotrap II revascularization device.
The Irvine, Calif.-based J&J division said that the device is designed to quickly restore natural blood flow by retrieving emboli within the vasculature of the brain, using minimal compression to protect against further complications.
Approval of the device came based on data from the Arise II study, in which investigators reported being able to restore blood flow in 80% of patients treated within three passes, and in approximately 50% within a single pass. More than 66% of patients ...
Source: Mass Device - May 21, 2018 Category: Medical Devices Authors: Fink Densford Tags: 510(k) Food & Drug Administration (FDA) Neurological Regulatory/Compliance Vascular cerenovus johnsonandjohnson Source Type: news
Philips, AHA, UPMC launch $30m heart-focused venture fund
Royal Philips (NYSE:PHG) said late last week it is joining with the American Heart Association and UPMC to launch a $30 million heart-focused collaborative venture capital fund.
The newly formed Cardeation Capital fund will support innovation in products for treating heart disease and stroke care. The fund will be managed by Aphelion Capital, with each major player contributing $10 million, Amsterdam-based Philips said.
Cardeation Capital will look to invest in companies trying to treat cardiovascular diseases and stroke and their risk factors, including diabetes, according to Philips.
“At Philips our goal is to imp...
Source: Mass Device - May 21, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Cardiovascular Wall Street Beat American Heart Assn. royalphilips UPMC 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
Penumbra acquires 90% interest in MVI Health JV, launches thrombectomy devices
Penumbra (NYSE:PEN) said today it acquired 40% of the outstanding shares of virtual reality joint venture MVI Health from collaborator Sixense, boosting its interest to 90%, and said it launched the Penumbra Jet 7 and Jet D reperfusion catheters.
The joint venture intends to commercialize healthcare applications of virtual reality technology, Alameda, Calif.-based Penumbra said, though more information on the specifics of the technology has not yet emerged.
Penumbra said it paid $20 million to Sixense to acquire the additional 40% interest in a deal with contains an anti-dilution provision intended to allow Penumbra to is...
Source: Mass Device - September 4, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Catheters Vascular Penumbra Inc. Source Type: news
