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 […]
Regulatory/Compliance
Tandem wins clearance for t:slim X2 pump with Eli Lilly fast-acting insulin in Europe
Tandem Diabetes Care (Nasdaq:TNDM) announced today that it received clearance for the use of rapid-acting insulin with its t:slim X2 pump. The company can now offer its automated insulin delivery (AID) system with Eli Lilly’s Lyumjev (insulin lispro-aabc injection) ultra-rapid-acting insulin in Europe. Previously, the t:slim X2 pump had clearance for use with Humalog and […]
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 […]
Sirtex Medical begins European launch for microsphere delivery system following EU approval
Sirtex Medical announced today that it received EU MDR certification to market its SIR-Spheres Y-90 resin microspheres and delivery systems. EU MDR authorization enables Woburn, Massachusetts-based Sirtex to kick off a European launch for its Siros delivery system. Siros offers an intuitive, visual and adaptable solution for physicians to administer SIR-Spheres to liver cancer patients. […]
Smiths Medical warns on infusion cassette reservoirs in Europe
ICU Medical’s Smiths Medical unit issued an urgent field safety notice in Europe to warn of issues with certain medication cassette reservoirs. Smiths Medical’s warning pertains to specific models and lots of its 50 mL and 100 mL CADD medication cassette reservoirs. Certain reservoirs may exhibit a weakened weld joint between the medication bag and […]
FDA clears Insulet Omnipod 5 for people with type 2 diabetes
Insulet (Nasdaq:PODD) announced today that the FDA cleared its Omnipod 5 automated insulin delivery for use by people with type 2 diabetes. Clearance makes Omnipod 5, the company’s latest-generation AID system, the first and only such system cleared for type 1 and type 2 diabetes. Its indication covers those ages 18 and older in the […]
ICU Medical recalls some infusion pump batteries, updates instructions
The FDA issued a notice to warn of a recall of ICU Medical (Nasdaq:ICUI) Plum 360 infusion pump system batteries due to a manufacturing defect. ICU Medical designed its Plum 360, Plum A+ and Plum A+3 systems for large-volume fluid infusion. The system delivers blood or blood products, drugs and other fluid mixtures through subcutaneous, […]
Tandem Diabetes Care begins updated software rollout after recall
Tandem Diabetes Care (Nasdaq:TNDM) announced today that it released version 2.8.2 of its Apple iOS t:connect mobile app in the U.S. The company initiated the new software release to remedy issues with prior versions of the technology. Its t:connect mobile app works in conjunction with the t:slim X2 automated insulin pump with Control-IQ technology. Tandem […]
Pneuma Systems infusion tech accepted into FDA STeP program
Pneuma Systems announced that the FDA accepted its PneumaFlow infusion controller and administration sets into its Safer Technologies Program (STeP). STeP, a collaborative program, helps reduce the time needed to develop and obtain marketing authorization for eligible devices. The FDA launched STeP in 2021, modeling the program on its breakthrough devices designation program. The program covers […]
Tandem Diabetes Care to issue app update after more software issues
Tandem Diabetes Care (Nasdaq:TNDM) provided an update on a recall from earlier this year related to an issue with its insulin pump software. In March, the San Diego-based company initiated a recall of Version 2.7 of the Apple iOS t:connect mobile app used in conjunction with the t:slim X2 pump with Control-IQ technology. Tandem recalled […]
