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 […]
CorFlow raises $9.7 million to launch clinical trial in Europe
Swiss medical device developer CorFlow Therapeutics said today that it has raised $9.7 million in the second close of its seed+ financing round. The first round closed in October 2017 at $2.7 million (CHF 2.6 million). The proceeds will finance the first-in-man clinical trial in Europe of the company’s controlled flow infusion (CoFITM) system, which […]
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 […]
One Drop wirelessly connects to Apple Watch
One Drop said today that its wireless blood glucose monitoring system can now connect directly to Apple Watch, making it the first diabetes company’s system to do so. One Drop was also the first such company to launch a companion Apple Watch app, but until now, users had to manually log blood glucose, food, medication, and […]
Paragonix touts performance of donor-heart transport technology
Paragonix Technologies (Braintree, Mass.) said today that its SherpaPak donor-heart transport system has been used successfully at Massachusetts General Hospital in Boston and other transplant centers around the U.S. and Europe. The SheraPak combines cooling technology with safe, consistent methods for cold ischemic storage and transport of donor organs, according to the company, which is […]
Hospitals saved money under Medicare bundled-payment program
Medicare payments for lower extremity joint replacement care fell by 3.3% among participating hospitals compared to a control group in the first year of a bundled payment pilot program, according to the Centers for Medicare & Medicaid Services (CMS). Quality of care was maintained in both settings, the federal health insurer said. CMS required all hospitals […]
Paradigm Spine wins coverage for spinal stenosis implant
BlueCross BlueShield of South Carolina has extended coverage to Paradigm Spine’s Coflex interlaminar stabilization implant, the company announced today. Approved by the FDA in 2012, Coflex is a non-fusion, motion-preserving stabilization implant for the treatment of lumbar spinal stenosis (LSS). Used in conjunction with a decompression procedure or in lieu of a spinal fusion, Coflex is a single-piece, […]