Swiss startup Luciole Medical announced today that it has closed a $5.5 million (CHF 5.3 million) Series A financing round to begin commercializing its minimally-invasive monitoring probe to measure blood oxygen levels in the brains of patients in intensive care units. New investor SVC Ltd. (a subsidiary of Credit Suisse), led the round with Blue […]
Gore’s aneurysm device for tricky anatomies implanted in Europe
The first European patient with a challenging anatomy has had the Gore Excluder conformable abdominal aortic aneurysm (AAA) endoprosthesis implanted, according to W.L. Gore & Associates. The next-generation endovascular aneurysm repair (EVAR) device is indicated to treat the broadest range of abdominal aortic aneurysms in patients with difficult anatomies. They include patients with proximal aortic neck angles […]
Brazil ANVISA develops new regulations for custom-made medical devices
By Stewart Eisenhart, Emergo Group ANVISA, Brazil’s medical device market regulator, has issued a public consultation to establish new requirements pertaining to custom-made devices. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its […]
FDA clears Olympus’ latest biopsy needle
Olympus said it has won FDA clearance for its EZ Shot Plus 25 G needle as well as an expanded indication for the EZ Shot 3 Plus product line for both fine needle aspiration (FNA) and fine needle biopsy (FNB). The approvals “can drive improved staging of disease and the potential to more easily connect patients […]
Hackers steal patient info from Guardant Health
Liquid biopsy company Guardant Health has revealed that 1,100 patients’ information was stolen in a phishing attack in July. The Redwood City, Calif. company said in an SEC filing that an unauthorized user hacked an employee’s email account and accessed patients’ names, contact information, birth dates, medical diagnosis codes, and, in a very limited number […]
GE, DARPA are taking on Type 2 diabetes with electricity
GE and DARPA are collaborating on a $2.9 million study of neuromodulation as a treatment for Type 2 diabetes. GE scientists have developed a novel, potentially breakthrough approach that could restore nerve signals to a healthy state using non-invasive devices that stimulate metabolic biosystems and produce drug-like effects, but with greater precision than traditional treatments, […]
Scapa to buy an Acelity wound-dressing facility in England
Scapa Healthcare will buy the Systagenix facility in Gargrave, England, from Acelity, Scapa announced this week. The deal includes manufacturing operations, sterilization services, warehouse facilities, R&D and regulatory support functions located in Gargrave. Scapa and Acelity will also enter into a long-term manufacturing and supply agreement for the advanced wound dressings offered by KCI, an Acelity company, manufactured […]
Avinger shareholders accept $5 million settlement
The plaintiffs in a class action suit against Avinger (NSDQ:AVGR) have approved the $5 million settlement that the company offered in March. Shareholders sued the company and several of its officers and directors claiming that they made false and misleading statements about Avinger’s original product, Pantheris, in its 2015 initial public offering. Avinger makes image-guided, catheter-based […]
FDA works with technology industry to promote digital health innovation
Scott Gottlieb, FDA commissioner; Jeff Shuren, Center for Devices and Radiological Health director Owing to digital advances, we’re experiencing a reimagination of health care delivery. Consumers are now empowered to take more control of their own health information to make better-informed decisions about their medical care and healthy living. These advances enable better health outcomes […]
Malaysian regulators extend medical device labeling requirement deadline
By Stewart Eisenhart, Emergo Group The Malaysian Medical Device Authority (MDA) is adding a three-year transition period for compliance to new medical device labeling rules. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or […]
3 flexible electronics outfits you need to know
Want to know where flexible electronics could take the medtech space? A good bet might be to look at where NextFlex is putting its money. The San Jose, Calif.–based hybrid electronics manufacturing institute provides funding for promising projects in areas ranging from healthcare to avionics to infrastructure monitoring. NextFlex recently announced $12 million in awards to fund […]
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