Senseonics (NYSE:SENS) announced today that it received CE mark for the next-generation Eversense E3 CGM system. Germantown, Maryland-based Senseonics offered its previous-generation continuous glucose monitor (CGM) with a 90-day wear time. Its next-generation Eversense E3 can be used for up to six months (180 days). Europe already had a 180-day Senseonics CGM system available (Eversense XL), […]
ZimVie launches duo of dental offerings
ZimVie (Nasdaq:ZIMV) announced today that it launched the T3 Pro tapered implant and Encode emergence healing abutment. Westminster, Colorado-based ZimVie designed the T3 Pro to deliver high primary stability and immediate function with a hybrid surface featuring its proprietary Osseotite surface on the implant collar, superimposed on the grit-blasted implant body. T3 Pro represents the […]
New authorized Roche COVID-19 test can also detect viral loads
Roche announced today that it received FDA emergency use authorization (EUA) for its cobas SARS-CoV-2 Duo diagnostic. Authorization covers the cobas SARS-CoV-2 Duo on the fully automated cobas 6800/8800 systems, expanding Roche’s COVID-19 portfolio and representing the first automated, RT-PCR assay for the in vitro qualitative and quantitative detection of SARS-CoV-2 RNA in nasal and […]
DermaSensor raises $10M as it braces for U.S. launch
DermaSensor announced today that it raised an additional $10 million as it prepares for a commercial launch in the U.S. Miami, Florida-based DermaSensor’s $10 million fundraising accompanies news that the company met all primary endpoints for two FDA pivotal studies, setting it up to potentially offer the only FDA-cleared, automated skin cancer detection tool on […]
Ibex wins CE mark for AI-powered gastric cancer detection tech
Ibex Medical Analytics announced today that it received CE mark approval for its Galen gastric cancer detection solution. Tel Aviv, Israel-based Ibex uses artificial intelligence (AI) and machine learning technology to power its Galen platform for cancer diagnostics based on hundreds of thousands of image samples scanned from biopsy slides through digital pathology. Galen won […]
GI Dynamics EndoBarrier meets endpoints in diabetes, obesity study
GI Dynamics today announced the results of a study of its EndoBarrier system that met efficacy and safety endpoints. Boston-based GI Dynamics designed its EndoBarrier endoscopically delivered device therapy as a non-surgical, alternative treatment for type 2 diabetes and obesity for patients who do not have adequate control of their conditions through their current medication […]
Owen Mumford appoints new director of R&D
Owen Mumford announced today that it appointed Bal Johal as its director of research and development, effective next month. Johal will become the director of R&D for the Woodstock, United Kingdom-based developer of medical devices, including the Aidaptus auto-injector, on July 4, 2022. Get the full story at our sister site, Drug Delivery Business News.
DJO parent Enovis unveils Arsenal ankle plating system
Enovis, the parent company of DJO, announced today that it launched its Arsenal ankle plating system. The Arsenal ankle plating system — the latest addition to the Enovis suite of foot and ankle products and an expansion of the Arsenal foot plating system, consists of 37 anatomically designed plates throughout nine plate families to accommodate […]
Boston Scientific to acquire majority stake in M.I. Tech
Boston Scientific (NYSE:BSX) announced today that it agreed with Synergy Innovation to purchase its majority stake in M.I. Tech. Marlborough, Massachusetts-based Boston Scientific will acquire a stake totaling approximately 64% in the publicly traded, Korea-based manufacturer and distributor of medical devices for endoscopic and urologic procedures. According to a news release, M.I. Tech created the […]
FDA seeking innovations to move beyond heater-cooler device problems
The FDA issued a notice today saying that it is working to evaluate new strategies to mitigate infections associated with heater-cooler devices. According to the notice, the administration is collaborating with professional societies, public health partners, heater-cooler manufacturers, and experts on the matter surrounding the heater-cooler devices used during medical and surgical procedures to warm or […]
ResMed to acquire out-of-hospital software developer Medifox Dan for $1B
ResMed (NYSE:RMD) announced today that it agreed to acquire German software company Medifox Dan in a deal worth $1 billion. Hildesheim, Germany-based Medifox Dan develops clinical, financial and operational software solutions for out-of-hospital care providers. Its offerings include care documentation, personnel planning, administration, billing and more. According to a news release, Medifox Dan’s solutions are […]