OM1 today announced positive results from its partnership with Medtronic (NYSE:MDT) evaluating the Propel corticosteroid-eluting implants. The Propel bioabsorbable implant family came to Medtronic through its acquisition of IntersectENT in 2022. OM1 and Medtronic partnered on their study to focus on healthcare resource use and long-term outcomes in patients with chronic rhinosinusitis (CRS) who underwent […]
Implants
Ascensia, Senseonics announce new CGM cost savings
Ascensia Diabetes Care and Senseonics today announced an extension to their Eversense Payment Assistance and Simple Savings (PASS) program. The program aims to help people in the U.S. access the Eversense E3 continuous glucose monitor (CGM) more affordably. It offers major savings for eligible individuals looking to experience the benefits of the long-term, implantable CGM. […]
Vivani prices $15M offering to support long-term drug delivery implant
Vivani Medical (Nasdaq:VANI) announced today that it entered into a securities purchase agreement worth $15 million in proceeds. The company entered the agreement with an institutional investor. It covers the purchase of just shy of 4 million shares of common stock and warrants to purchase common stock. Alameda, California-based Vivani priced the shares at $3.80 […]
FDA submission for 365-day CGM from Senseonics is ‘imminent’
Senseonics (NYSE:SENS) shares dipped after hours on fourth-quarter results that came in ahead of the consensus forecast. The company also reported an “imminent” submission of its latest, longest-lasting continuous glucose monitoring (CGM) technology. Shares of SENS fell 3.5% to 69¢ apiece after the market closed today. MassDevice’s MedTech 100 Index — which includes stocks of […]
Vivani has positive data for long-term drug-eluting weight loss implant as it shifts strategy
Vivani Medical (Nasdaq:VANI) today announced positive pre-clinical data on weight loss effects for its long-term exenatide implant. Alameda, California-based Vivani has its miniature, twice-yearly exenatide implant — NPM-115 — under development to treat chronic weight management. The company also disclosed that it included semaglutide as the active pharmaceutical ingredient in its NPM-139 subdermal GLP-1 implant […]
Senseonics earns expanded Medicare coverage for long-term implantable CGM
Senseonics (NYSE:SENS) and Ascensia Diabetes Care today announced expanded Medicare coverage for the Eversense E3 CGM system. Medicare implemented Local Coverage Determinations (LCDs) providing access to implantable CGM for basal-only patients. It significantly expands access to Senseonics’ long-term (six months) implantable glucose monitor. The expansion for implantable CGMs includes all people with diabetes using insulin. […]
Former Tandem CCO joins Ascensia as president of CGM
Ascensia Diabetes Care parent company PHC Holdings and Senseonics announced today that Ascensia named Brian Hansen its president of CGM. Hansen’s appointment to the newly created role at the global distributor of Senseonics’ Eversense CGM went into effect today, Feb. 6. Responsibilities for Hansen include the global commercialization and growth of the Eversense system. The fully […]
Glucotrack has positive data for implantable continuous blood glucose monitor
Glucotrack (Nasdaq:GCK) announced today that it completed the first preclinical study of its implantable continuous blood glucose monitor (CBGM). Rutherford, New Jersey-based Glucotrack aimed to assess the implant technique and device safety in the study. Additionally, the study used a small sample size of sensors to determine device functionality. Despite no intent to conduct an […]
Elutia submits drug-eluting biomatrix for use with cardiac implants to FDA
Elutia (Nasdaq:ELUT) announced today that it submitted a 510(k) premarket notification to the FDA for its drug-eluting biomatrix. The company designed its next-generation CanGarooRM for use with cardiac implantable electronic devices like pacemakers and defibrillators. A bioenvelope, CanGarooRM stabilizes the implantable devices. Made from a natural biomaterial that promotes a regenerative healing response, the biomatrix […]
FDA approves Glaukos iDose TR glaucoma-treating drug delivery implant
Glaukos (NYSE:GKOS) announced today that the FDA approved a New Drug Application (NDA) for its iDose TR implant. The approval allows for one administration per eye of iDose TR (travoprost intracameral implant) 75 mcg. The indication for the prostaglandin analog covers the reduction of intraocular pressure (IOP) in patients with ocular hypertension (OHT) or open-angle […]
