Medinol today announced the successful first-in-human implantation of its ChampioNIR drug-eluting peripheral stent. Dr. Gerard S. Goh and Dr. Thodur Vasudevan of the Alfred Hospital in Melbourne, Australia, completed the stent implant. The company says it introduces a “revolutionary advancement” in the mechanics, durability and drug delivery of peripheral drug-eluting stents. Tel Aviv, Israel-based Medinol […]
Implants
Vivani can begin first-in-human GLP-1 implant trial in Australia following regulatory approval
Vivani Medical (Nasdaq:VANI) today announced that Australian authorities approved a first-in-human clinical trial for its subdermal GLP-1 implant. The LIBERATE-1 trial will evaluate the miniature GLP-1 (exenatide) implant in obese and overweight subjects. This follows FDA approval for an investigational new drug (IND) application for the company’s implant in June. The FDA lifted the clinical hold […]
CereVasc data shows that eShunt could help deliver gene therapies to the central nervous system
CereVasc shared data from a study demonstrating that its eShunt system may help deliver gene therapies to the central nervous system (CNS). eShunt, a minimally invasive system, includes an endovascularly implantable cerebral spinal fluid shunt and delivery components. CereVasc designed the system to enable transvenous-transdural access to the CNS to treat communicating hydrocephalus (CH) without […]
Senseonics wins FDA nod for 365-day implantable CGM
Senseonics (NYSE:SENS) announced today that it received FDA clearance for its next-generation Eversense 365 CGM system. Eversense 365, an implantable continuous glucose monitor (CGM), becomes the world’s first 365-day CGM system, according to the company. Its indications cover people with type 1 and type 2 diabetes aged 18 years and older. The system also received clearance […]
CorFlow Therapeutics raises $48.5M for diagnostic, drug delivery platform
CorFlow Therapeutics announced today that it raised €44 million ($48.5 million) to support its novel diagnostic and drug delivery platform. Broadview Ventures and Panakes Partners led the financing round. 415 Capital, Merieux Equity Partners, Merieux Equity Partners, Laerdal Million Lives Fund, Wellington Partners, M&L Investments, Unorthodox Ventures, KOFA Healthcare and Monte Carlo Capital also participated. […]
Elutia announces first implant of drug-eluting bioenvelope for pacemakers and neurostimulators
Elutia (Nasdaq:ELUT) announced the first-ever patient implant of its EluPro drug-eluting biologic envelope cleared by the FDA. Dr. John Catanzaro of the East Carolina University Health Medical Center in Greenville, North Carolina, performed the first procedure. Elutia says this marks the first implant of the world’s first antibiotic-eluting biologic envelope. Elutia designed EluPro to prevent […]
Glucotrack survey highlights interest in 3-year continuous blood glucose monitor implant
Glucotrack (Nasdaq:GCTK) today announced findings from a market research study demonstrating the acceptance of its CBGM concept. Rutherford, New Jersey-based Glucotrack develops a small device placed under the skin for continuous blood glucose monitoring. It designed the technology to deliver continuous, accurate blood glucose monitoring for up to three years. This would eliminate some of […]
FDA says Alcyone Therapeutics can continue study of drug delivery implant
Alcyone Therapeutics announced today that the FDA approved continued enrollment in a study of its ThecaFlex DRx drug delivery system. The company can continue enrolling in the PIERRE FDA investigational device exemption study for the implantable medical device. It evaluates the system, comprised of a subcutaneous port and intrathecal catheter system. This system provides chronic […]
Focus collaborates with Glucotrack on implantable CBGM
Focus recently announced that it entered into a collaboration with Glucotrack to develop an implantable continuous blood glucose monitor (CBGM). The company said in a LinkedIn post that it expects the long-term, implantable technology to transform how people with diabetes interact with their condition. Focus and Glucotrack want to provide technology that seamlessly integrates into […]
Vivani expects to start long-term GLP-1 implant trial this year
Vivani Medical (Nasdaq:VANI) today announced that it expects to initiate the first clinical study of its long-term GLP-1 implant this year. The company anticipates a fourth-quarter start for its NPM-115 program in Australia, pending regulatory clearance there. This program looks at the investigational six-month GLP-1 implant for chronic weight management. The company intends to evaluate […]
