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Oculis raises unspecified amount in Series B for drug-device eye disease combo
Ophthalmalogical developer Oculis said today it closed a Series A round of financing to support its solubilizing nanoparticle drug delivery platform, currently being designed to deliver drugs to treat...
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SynCardia denies competitor’s market exit claim
SynCardia Systems isn’t exiting the market quite yet, according to a press release posted today in response to a competitor’s claim. Syncardia makes an artificial heart system designed to replace the...
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Japanese MHLW Aligns ISO 13485:2016 with Its Own QMS Requirements
By Stewart Eisenhart, Emergo Group Japan’s Ministry of Health, Labour and Welfare (MHLW) has published an administrative notice on how the new ISO 13485:2016 quality system standard for medical devices...
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Medpace IPO drums up $185m
Contract research organization Medpace (NSDQ:MEDP) said yesterday that its initial public offering closed after raising more than $185 million, including an underwriter’s over-allotment that added more...
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William Demant moves hearing aid production from U.S., Denmark to Poland, Mexico
William Demant (CPH:WDH) plans to shift production from the U.S. and Denmark to Poland and Mexico to cut costs by around $30 million (DKK200 million) a year, the Danish hearing aid maker said today. A...
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Another InVivo Therapeutics spinal scaffold implant patient improves
InVivo Therapeutics (NSDQ:NVIV) said today that the 9th spinal cord injury patient, implanted with its neuro-spinal scaffold last month, is already showing signs of improvement. InVivo’s neuro-spinal...
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FDA warns on using Custom Ultrasonics device on duodenoscopes
The FDA today reiterated its warning not to use the an automated endoscope reprocessor made by Custom Ultrasonics with a type of ‘scope called duodenoscopes, which have been linked to deadly “superbug”...
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Jury convicts ex-banker in healthcare insider trading trial
After signaling last week that it might be headed for deadlock, a federal jury today convicted an ex-investment banker on insider trading charges related to a quintet of medical device and life science...
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Merz buys tattoo-removal company ON Light Sciences
Healthcare company Merz said today it picked up On Light Sciences, makers of the DeScribe Transparent perfluorodecalin patch designed for laser tattoo removal, for an undisclosed amount. Raleigh,...
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Molex buys Phillips-Medisize
Electronics developer and interconnected solutions company Molex said today it is buying Phillips-Medisize for an undisclosed amount, with an expected closing date in the fall. Hudson, Wisc.-based...
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FDA sends warning letters to 12 medical device companies
The FDA today published the warning letters it sent recently to 12 medical device companies in the U.S. and overseas for violations found during recent inspections. The federal safety watchdog’s...
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Levita Magnetics wins de novo FDA clearance for gallbladder surgery device
Medical device developer Levita Magnetics said today it won FDA de novo clearance for its magnetic surgical system with indications for gallbladder removal surgery, and launched the system in the U.S....
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FDA adds new clearance for Cianna Medical’s Savi Scout breast cancer locator
Cianna Medical said today it won additional FDA 510(k) clearance for its Savi Scout radar localization breast cancer device, now cleared to be placed at the lumpectomy site up to 30 days prior to...
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MassDevice.com +5 | The top 5 medtech stories for August 17, 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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Three ways to get more out of your field inventory team
If you operate in the orthopedic, tissue, biologics, or any other space that leverages a combination of loaner and consignment inventory, you likely have a field sales team. This team represents your...
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Fresenius Kabi unveils $250m expansion for Ill. plant
Fresenius (NYSE:FMS) business group Fresenius Kabi said today it is investing approximately $250 million over 10 years to expand its Melrose Park manufacturing site. The Lake Zurich, Ill.-based...
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California Life Sciences Assn. and OCTANe ink deal
The California Life Sciences Association today said it inked a deal with Orange County life science and tech accelerator OCTANe to “accelerate the growth of Orange County’s life sciences sector.”...
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B. Braun integrates Infusomat Space pump with Epic’s EMR system
B. Braun Medical said today it completed system integrations of its Infusomat Space Pump with Epic’s integrated EMR system. Get the rest of the story at our sister site, Medical Design &...
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Study: Revascularization beats medical management for intermittent...
Revascularization through endovascular or surgical interventions may be superior to medical management for peripheral artery disease patients with intermittent claudication, according to a new study...
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US FDA reduces medical device 510(k) registration fees 10% for 2017
By Stewart Eisenhart, Emergo Group The US Food and Drug Administration’s medical device registration user fees for the agency’s 2017 fiscal year have decreased nearly across the board, including 10%...
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