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PathMaker and Feinstein Inst launch MyoRegulator spasticity trial
PathMaker Neurosystems said today it paired with the Feinstein Institute and Northwell Health to launch an IRB-approved clinical trial of its MyoRegulator device designed to treat muscle spasticity....
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InVivo adds 19th site at University of Virginia site to Inspire study
InVivo Therapeutics (NSDQ:NVIV) is continuing to add sites to the Inspire study of its NeuroSpinal Scaffold, announcing today that it added a new site at the Charlottesville’s University of Virginia...
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Advanced Brain Monitoring wins FDA nod for Sleep Profiler PSG2
Sleep and neurological disorder device developer Advanced Brain Monitoring said today it won FDA 510(k) clearance for its Sleep Profiler PSG2 overnight EEG designed for to diagnose sleep apnea. The...
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FDA clears Medtronic’s miniature Micra transcatheter pacer
Medtronic (NYSE:MDT) said today it won FDA premarket approval for its Micra transcatheter pacing system, which it claims is the world’s smallest pacemaker. The Micra transcatheter pacing system, which...
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Johnson & Johnson’s $5m mesh settlement could push costs higher
Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon could be facing a steeper-than-expected tab when it comes to settling the more than 46,000 product liability lawsuits brought over its pelvic mesh...
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US regulators launch online tool for mobile medical app developers
By Stewart Eisenhart, Emergo Group The US Federal Trade Commission (FTC) has published an online tool designed to help developers of mobile medical and telehealth apps determine which laws and...
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ReCor Medical launches trial for Paradise renal denervation device
ReCor Medical said today that it’s enrolled the 1st patients in the 292-patient Radiance-HTN study of its Paradise renal denervation device for treating hypertension. The blinded, randomized and...
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Report: Baxter to shutter Colorado plant
Baxter (NYSE:BAX) is reportedly planning to shutter a plant in Englewood, Colo., over the next year. “Baxter has informed employees in its [Douglas County] … facility of the company’s plans to exit the...
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St. Jude Medical launches Trifecta GT valve in Europe
St. Jude Medical (NYSE:STJ) said today that it launched its Trifecta GT aortic valve replacement in the European Union, hailing the device as its most advanced tissue valve. The Trifecta GT won CE Mark...
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Dexcom warns on G4, G5 CGMs
Dexcom Inc. (NSDQ:DXCM) today released a customer notice warning of possible malfunctions with the audible alarms and alerts from its G4 Platinum and G5 Mobile continuous glucose monitor systems. San...
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Edap looks to raise $11m in direct placement round
Edap (NSDQ:EDAP) said today it inked an agreement with institutional investors for the placement of 3.3 million shares at $3.50 a piece, bringing in an estimated $11.5 million for the company....
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Sorrento lures ex-Hologic exec Herde | Personnel Moves April 7, 2016
Sorrento lures ex-Hologic exec Herde Sorrento Therapeutics (NSDQ:SRNE) said it lured Kevin Herde, the former vice president of global blood screening & alliance management at Hologic (NSDQ:HOLX),...
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Adavium buys 2 firms in Brazil, $21m in funding, adds ex-GE HC exec Goulart...
Brazilian medical device and diagnostic company Adavium Medical, formerly known as Advance Medical, said today it picked up Alka Tecnologia and Hemogram Industria e Comercio, raised $21m in a Series C...
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Enhancing Relationships between Monitors and Research Coordinators
The relationship between a clinical research monitor and site coordinator can play a major role in ensuring data integrity and compliance with applicable regulations. Positive relationships can foster...
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MassDevice.com +5 | The top 5 medtech stories for April 7, 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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Toshiba wins clearance from USAF for Aplio Platinum ultrasound systems
Toshiba (TYO:6502) said today it won clearance through an “authorization to operate” with the U.S. Air Force for the company’s Aplio Platinum series of ultrasound systems. Toshiba’s Aplio 500 platinum...
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Report: Hospitals doubt medtech can help meet CMS outcome goals
While the Affordable Care Act could lead to improved partnerships between medtech manufacturers and hospitals, a new survey and report from ZS Associates indicates that hospital execs aren’t convinced...
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FDA approves Abiomed’s Impella with indication for cardiogenic shock
Abiomed (NSDQ:ABMD) said today it won expanded FDA premarket approval indications for its Impella line of percutaneous heart pumps to treat patients suffering cardiogenic shock following acute...
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Monteris wins FDA IDE clearance for NeuroBlate trial
Monteris Medical said today it won FDA investigational device exemption clearance for a trial of its NeuroBlate system for treating medically refractory epilepsy. The NeuroBlate system is designed to...
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Mauna Kea inks research collab deal with EM Imaging
Mauna Kea (ENT:MKEA) said yesterday it inked a research collaboration deal with Edinburgh Molecular Imaging to explore the combination of EM Imaging’s in vivo optical imaging agents with Mauna Kea’s...
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