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Mylan settles EpiPen pricing probe with $465m
Mylan (NSDQ:MYL) agreed last week to pay $465 million to settle claims that it underpaid Medicaid for its EpiPen auto-injector by misclassifying the device as a generic. Last week, the Centers for...
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Medtech startup teams with GM on robotic glove
(Reuters) — Bioservo Technologies, a medical technology startup that makes a light-weight robotic “extra muscle” glove for people with weak grips, is teaming up with carmaker General Motors (NYSE:GM)...
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Gamida Cell wins FDA breakthrough therapy designation for NiCord cell graft
Gamida Cell said today that it won breakthrough therapy designation from the FDA for its lead product candidate, NiCord. The Jerusalem-based company’s expanded cell graft is designed to be an...
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Synaptive Medical raises $3.7m
Synaptive Medical last week told the U.S. Securities & Exchange Commission that it raised $3.7 million in an equity round. Toronto-based Synaptive, which makes brain imaging products, did not...
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St. Jude wins FDA nod, launches PressureWire X FFR system
St. Jude Medical (NYSE:STJ) said today that it won 510(k) clearance from the FDA for its PressureWire X guidewire fractional flow reserve measurement system and launched the device in the U.S. The...
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Relievant Medsystems raises $36m
Relievant Medsystems said today that it raised a $36 million equity round to support clinical trials for its Intracept intraosseous nerve ablation system. The Intracept system is designed to use radio...
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FDA Finalizes Guidance On Medical Device Safety Evaluation
On June 16, FDA finalized a guideline of broad significance for the medical device industry, Use of International Standard ISO 10993, ‘Biological Evaluation of Medical Devices Part 1: Evaluation and...
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BioStable Science & Engineering seeks FDA de novo indication for Haart 300...
Cardiovascular device developer BioStable Science & Engineering said today it completed a de novo application to the FDA as it seeks Class II designation for its Haart 300 aortic annuloplasty...
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DoJ settles Grifols probe
The U.S. Justice Dept. closed its probe of Grifols (NSDQ:GRFS), according to an SEC filing from the company posted today. The DoJ told the company that it closed its investigation, which concerns...
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Microchip imaging platform for roundworms could accelerate research
Researchers have developed a microchip imaging platform to image-analyze thousands of roundworms simultaneously, according to the Cockrell School of Engineering at the University of Texas at Austin....
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MassDevice.com +5 | The top 5 medtech stories for October 11, 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, MDIC press their ‘Case for Quality’
The Case for Quality, a collaborative effort between the FDA and the medical device industry, released its 1st report today, focused on the safety and efficacy of knee implants and cardioverter...
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Mazor Robotics touts prelim Q3 sales
Mazor Robotics (NSDQ:MZOR) today released preliminary sales data for its 3rd quarter, with purchase orders for 25 of its systems, including pre-orders for its Mazor X robotic spinal system, and revenue...
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Researchers develop personalized 3D-printed vascular stents
Researchers from Northwestern University have developed a 3D-printed vascular stent that can be personalized to the patient, the school reported this week. The stents are made of a biodegradable,...
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Engineered “building blocks” could form complex nano-structures
A team of researchers from the University of Melbourne have developed a method to turn particles into “building blocks” for complex nano-structures, according to a study published in Nature...
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U.S. Special Forces test Oska’s Pulse anti-pain device
Oska Wellness said today its Oska Pulse chronic pain management device is being tested by members U.S. Special Forces, specifically the Navy SEALS, with positive early results, the company said. The...
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Tepha closes royalty rights buyout from Metabolix
Implantable medical device developer Tepha said today it completed a buy-out of its roylaty obligations with former licensor and parent company Metabolix. Get the rest of the story at our sister site,...
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Vertiflex raises $15m
VertiFlex raised $15 million in a new round of debt financing, according to an SEC filing posted today. Money in the round came from 6 unnamed sources, according to the filing, and includes $148,999 in...
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Saudi FDA to regulate borderline products as pharmaceuticals
By Stewart Eisenhart, Emergo Group EMERGO SUMMARY OF KEY POINTS: The Saudi Food and Drug Authority (SFDA) now regulates some borderline products as drugs rather than medical devices. For affected...
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Fortimedix Surgical raises $12m for single-port surgery device
Fortimedix Surgical said today that it raised a $12 million Series A round it plans to use to commercialize its newly approved device for single-port laparoscopic surgeries. The round, which brought in...
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