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 […]
Implants
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 […]
Encellin closes $9.9M financing to support implantable drug delivery pouch
Encellin announced today that it closed a $9.9 million financing round to support its cell encapsulation platform. The San Francisco-based company develops an encapsulated cell replacement therapy (EnCRT). It isolates therapeutic cells from the body’s immune system to help therapeutic cells survive in the body. Once implanted, cells within the EnCRT can exchange biomolecules with […]
GlucoTrack transitions strategic focus to long-term implantable CGM
Glucotrack (Nasdaq:GCTK) President and CEO Paul V. Goode today issued a statement to shareholders outlining strategic changes. Goode’s letter to shareholders announced a redefined strategic direction. The company wants to move closer to becoming a leader in the diabetes market. According to Goode, the diabetes market has undergone a transformation over recent years. He attributed […]
Senseonics posts mixed Q3, iCGM designation expected next year
Senseonics (NYSE:SENS) shares remained mostly unchanged today on third-quarter results that came in mixed compared to the consensus forecast. Shares of SENS dipped 0.3% at 51¢ apiece before the market opened today. The Germantown, Maryland-based implantable continuous glucose monitor (CGM) maker posted losses of $24.1 million. That equals 4¢ per share on sales of $6.1 […]