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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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FDA approves Raindrop presbyopia inlay from ReVision Optics
ReVision Optics won pre-market approval from the FDA yesterday for its Raindrop near vision inlay, a corneal implant designed to treat presbyopia. The Raindrop is a microscopic hydrogel inlay placed in...
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Gecko Biomedical lands $1.6m loan for surgical adhesives
Gecko Biomedical said today that it landed a $1.6 million, interest-free loan from Bpifrance for the surgical adhesives it’s developing. Paris-based Gecko, which pulled down a $25 million Series A2...
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Report: Japan OKs Canon’s $6.5B Toshiba Medical buy, despite reservations
Anti-trust regulators in Japan reportedly approved the $6.5 billion acquisition of Toshiba‘s (TYO:6502) medical device business to Canon (NYSE:CAJ), but warned about the deal’s questionable structure....
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Medical device companies fear parallel regulation after Brexit vote
Medical Device companies fear that Britain’s exit from the European Union could result in a “parallel” regulatory system which would require them to file separate applications to access the U.K. and...
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FDA approves Concordia’s Photofrin 630 laser
Concordia International (NSDQ:CXRX) said it won pre-market approval from the FDA for its Photofrin 630 laser, which is designed to activate an anti-cancer drug in patients with throat and lung cancers....
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Study: Initially CE Marked medical devices have higher recall rate
U.S. medical devices which won CE Mark approval in the European Union prior to gaining FDA clearance have a nearly 3 times higher rate of safety alerts and recalls, according to a new study published...
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Appeals court upholds patent win for Medtronic’s Cardiocom
A federal appeals court yesterday upheld a win for Medtronic (NYSE:MDT) subsidiary Cardiocom in a patent battle with Robert Bosch Healthcare Systems. The U.S. Court of Appeals for the Federal Circuit...
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Leading the battle against sepsis: A MassDevice podcast with Spectral Medical...
Spectral Medical CEO Dr. Paul Walker has been focused on finding a solution to identify and treat sepsis, and specifically endotoxins that are known to trigger it, for over 20 years. Sepsis affects...
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JustRight Surgical wins FDA 510(k) for 3mm pediatric vessel sealing system
JustRight Surgical said today it won FDA 510(k) clearance for its JustRight 3mm pediatric surgery vessel sealing system. The Boulder, Colo.-based company touted the win as the 1st and only from the FDA...
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MassDevice.com +5 | The top 5 medtech stories for June 30, 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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SRS Medical wins CE Mark for Spanner prostate stent
SRS Medical Systems said yesterday it won CE Mark approval in the European Union for its Spanner temporary prostatic stent designed to be used as both an indwelling Foley catheter and an intermittent...
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Luminex closes Nanosphere buy
Luminex (NSDQ:LMNX) said today that it closed its buy of Nanosphere (NSDQ:NSPH) through the purchase of 45.3 million shares at $1.70 per share, offering up $76.9 million for the company. The company...
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NuVasive ponies up $45m to settle Medtronic beef
NuVasive Inc. (NSDQ:NUVA) said yesterday that it agreed to pay Medtronic (NYSE:MDT) $45 million to settle their long-running patent infringement beef. The companies expect to reach a final agreement...
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