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Unfazed by Brexit, PureTech launches Sonde voice diagnostics firm
Life sciences incubator PureTech Health (LON:PRTC), unfazed by the worldwide impact of the U.K.’s vote to leave the European Union, announced its latest venture today: Sonde Health, which aims to use a...
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Insurer launches trial of Avinger’s Pantheris atherectomy device
Avinger (NSDQ:AVGR) said yesterday that it is collaborating with health insurers Highmark Health and Allegheny Health Network to launch a trial of its Pantheris image-guided atherectomy device designed...
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Gore touts Viabahn endoprosthesis superiority over PTA in new study
W.L. Gore & Associates today released results from a clinical study of its Viabahn endoprosthesis in AV access graft outflow interventions, touting a 50% increase over percutaneous transluminal...
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Report: Medtronic files for FDA approval of MiniMed 670G ‘artificial pancreas’
Medtronic (NYSE:MDT) has reportedly filed for pre-market approval from the FDA for its MiniMed 670G “artificial pancreas,” which is designed to automatically track and adjust blood sugar levels in...
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CorMatrix lands CE Mark for CanGaroo surgical envelope
CorMatrix Cardiovascular said today that it won CE Mark approval in the European Union for its CanGaroo ECM surgical envelope for implanted cardiac devices. Roswell, Ga.-based CorMatrix won 510(k)...
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MassDevice.com +5 | The top 5 medtech stories for June 28, 2016
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...
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‘Donnie Brasco’ brother sues Zimmer
A former sales rep for Zimmer Biomet (NYSE:ZBH) – who is the brother of the FBI agent on whom the movie “Donnie Brasco” is based – yesterday filed a $15 million lawsuit accusing the orthopedics giant...
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China FDA proposes review process for high-priority medical device registration
By Stewart Eisenhart, Emergo Group Chinese medical device regulators are seeking comment on a draft proposal for determining which devices qualify for the country’s high-priority review program, and in...
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Cardiovascular Systems settles kickbacks lawsuit for $8m
Cardiovascular Systems (NSDQ:CSII) yesterday said it agreed to pay $8 million and sign a corporate integrity agreement to settle a False Claims Act lawsuit based on allegations from a former sales rep...
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Zoll Medical wins $400m contract with U.S. Defense Dept.
Zoll Medical landed a contract with the U.S. Defense Dept. worth $400 million to supply vital signs monitors, the Pentagon said yesterday. The 1-year deal includes 5 1-year extension options, according...
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Entellus Medical pays $11m for Cogent’s XeroGel
Entellus Medical (NSDQ:ENTL) said it paid $11 million in cash to acquire the XeroGel surgical sinus packing from Cogent Therapeutics. “We are pleased to secure ownership of this best-in-class nasal...
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Avita taps IMS for BARDA economics study of ReCell
Avita Medical (ASX:AVH) said today it tapped health economics group IMS Health to join in an study of its ReCell regenerative medical device to evaluate its economic benefits when used at U.S. burn...
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Baxter wins Health Canada nod for Amia peritoneal dialysis system
Baxter (NYSE:BAX) said today that it won a nod north of the border for its Amia automated peritoneal dialysis system. The Health Canada approval makes Amia the 1st automated peritoneal dialysis device...
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Echo Therapeutics launches pre-regulatory CGM component testing
Echo Therapeutics (NSDQ:ECTE) said today it began stand-alone component and integrated testing of its NextGen continuous glucose monitoring system prototypes and selected a clinical research...
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Biostage files for orphan drug designation for Cellspan artificial esophagus
Organ regeneration specialist Biostage (NSDQ:BSTG) said it asked the FDA for orphan drug status for its Cellspan artificial esophagus. If the request is granted, Holliston, Mass.-based Biostage,...
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AtriCure wins CE Mark for AtriClip Pro2 LAA occluder
AtriCure (NSDQ:ATRC) said today it won CE Mark approval in the European Union for the AtriClip Pro2 left atrial appendage exclusion system designed for minimally-invasive LAA occlusion procedures. The...
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HeartStitch touts 1st-in-human use in aortic valve surgery
Structural heart focused HeartStitch today touted the 1st-in-man use of the company’s HeartStitch technology in a transapical access and closure procedure at the National Cardiac Research Center in...
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Nico touts studies using BrainPath to treat hemorrhagic stroke
Nico Corp today released data from 2 recently published studies which utilized its BrainPath Approach to treat hemorrhagic stroke, touting a 95% clot reduction and no mortalities associated with the...
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MassDevice.com +5 | The top 5 medtech stories for June 29, 2016
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...
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FDA Advisory Committee members and ‘appearance issues’
By: Michael Ortwerth, Ph.D. FDA relies on its advisory committees as a source of independent scientific and technical expertise and advice on challenging public health issues. Most advisory committee...
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