Clik here to view.
Judge blocks FDA’s move to shutter Amniotic Therapies
A federal judge this month blocked the FDA’s bid to force Amniotic Therapies to shut down completely, ruling instead that the maker of placental tissue-based wound-healing products must only cease...
View ArticleClik here to view.
FDA releases July 2016 510(k) clearances
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD July 2016 TOTAL 510(k)s THIS PERIOD 236 TOTAL WITH SUMMARIES 220 TOTAL WITH STATEMENTS 16 DEVICE: Dakin's Skin and...
View ArticleClik here to view.
Report: Genstar Capital shops Tecomet for $1B
Private equity player Genstar Capital is reportedly shopping Tecomet to potential buyers for more than $1 billion. Genstar tapped investment bank William Blair & Co. to auction Tecomet, according...
View ArticleClik here to view.
BioTelemetry CE Mark for Holter analysis software
BioTelemetry (NSDQ:BEAT) said on Monday it won CE Mark approval in the European Union for its Holter analysis software. The Pennsylvania-based company said the device is usable on a stand-alone basis...
View ArticleClik here to view.
Swedish hospital behind Nobel prize criticised over medical scandal
(Reuters) – The reputation of the Karolinska Institute, one of Sweden’s top hospitals that awards the Nobel prize for medicine, has been badly damaged by allegations patients died as a result of a...
View ArticleClik here to view.
Philips, Qualcomm ink connected health deal
Royal Philips (NYSE:PHG) and Qualcomm (NASDAQ: QCOM) subsidiary Qualcomm Life said today they inked a collaborative, strategic technology deal aimed at developing connected health solutions. The...
View ArticleClik here to view.
Skyline Medical surges on JV with electronic security firm
Skyline Medical saw shares surge upwards nearly 30% after announcing a joint venture with Electronic On-Ramp, providing the company with access to bids on procurement contracts for up to $550 million...
View ArticleClik here to view.
MassDevice.com +5 | The top 5 medtech stories for August 31, 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...
View ArticleClik here to view.
ResMed initiates recall Down Under of Astral ventilators
ResMed (NYSE:RMD) earlier this month initiated an Australian recall of its Astral 100 and Astral 150 ventilators, due to internal battery issues. While the internal batteries are intended to provide...
View ArticleClik here to view.
Novuson Surgical wins $1.5m NIH grant
Spun-out med device firm Novuson Surgical said today it won $1.47m through a Phase 2 SBIR grant from the National Institute of Health’s National Heart, Lung and Blood Institute. Money came as part of a...
View ArticleClik here to view.
Making heart surgery as simple as possible with MIS techniques
Tertiary care centers such as the Boston Children’s Hospital Heart Center have led the way in groundbreaking surgical innovations for years, pushing boundaries and correcting ever more complex...
View ArticleClik here to view.
BioSciKin puts $2m into Exact Imaging
Micro-ultrasound developer Exact Imaging said today that Chinese bio-tech company BioSciKin is investing $2.2 million (CDN $3 million) as a syndicate partner in Exact Imaging’s $15.8 million (CDN $20.7...
View ArticleClik here to view.
Judge lifts bail, travel restrictions on ex-Acclarent execs
Facteau (l) and Fabian A federal judge in Boston this week lifted the bail and travel restrictions imposed on a pair of former Acclarent executives who were acquitted of felony fraud charges in July....
View ArticleClik here to view.
Alere airs dirty laundry in Abbott lawsuit
Abbott (NYSE:ABT) is deliberately stalling with federal anti-trust regulators, hoping to snuff the pending, $5.8 billion buyout of Alere (NYSE:ALR), according to a lawsuit unveiled this week in a...
View ArticleClik here to view.
FDA approves Medtronic’s Enlite continuous glucose sensor
Medtronic (NYSE:MDT) said today that the FDA approved its Enlite sensor for the iPro2 Professional continuous glucose monitor. Medtronic said the Enlite device, a disposable sensor designed to be worn...
View ArticleClik here to view.
Pivotal trial pits St. Jude Medical’s Amplatzer Amulet anti-stroke device...
St. Jude Medical (NYSE:STJ) said today that it launched a U.S. pivotal trial for its Amplatzer Amulet cardiac implant, which is designed to reduce the risk of stroke in patients with atrial...
View ArticleClik here to view.
Stryker acquires Ivy Sports Medicine and its meniscus repair device
Stryker (NYSE:SYK) said today that its endoscopy division acquired Ivy Sports Medicine and its collagen meniscus implant for an undisclosed amount. Kalamazoo, Mich.-based Stryker touted the Ivy Sports...
View ArticleClik here to view.
Deaths prompt FDA warning on Baxter’s Vascu-Guard patch
Updated to clarify the recent notice did not relate to a recall initiated in June 2015. The FDA today released a notice warning of issues with Baxter‘s (NYSE:BAX) Vascu-Guard peripheral vascular patch...
View ArticleClik here to view.
Boehringer Ingelheim, Qualcomm team on connected inhaler
Boehringer Ingelheim Pharmaceuticals and Qualcomm (NSDQ:QCOM) subsidiary Qualcomm Life yesterday said they’re partnering to create an inhaler that can track user information, hoping to improve outcomes...
View ArticleClik here to view.
Micrima brings in $3.4m for breast imaging tech
Micrima said today it raised $3.4 million (UK £2.6 million) in a new round of financing to support its Maria breast imaging system, with commercialization slated for the end of the year. Micrima’s...
View Article