Dexcom (Nasdaq:DXCM) announced that, following the conclusion of the third quarter, it submitted its 15-day G7 CGM to the FDA. G7, the company’s latest-generation continuous glucose monitor (CGM), presently has approval for a 10-day wear time. Shares of DXCM were up slightly at the opening of trading today. Yesterday evening, Dexcom also reported third-quarter results […]
Regulatory/Compliance
FDA approves IDE for Medtronic Prevail drug-coated balloon
Medtronic (NYSE: MDT) announced today that it received FDA investigational device exemption (IDE) for its Prevail drug-coated balloon (DCB). The medtech giant can now begin a pivotal clinical trial for the coronary paclitaxel DCB for in-stent restenosis (ISR) and de novo small vessel disease. It plans to use data from its Prevail Global Clinical Program […]
ViCentra wins CE mark for Kaleido insulin pump
ViCentra announced that it received CE mark approval for its Kaleido insulin pump under European Medical Device Regulation (EU MDR). Utrecht, The Netherlands-based ViCentra aims to deliver high-quality, user-friendly solutions for people with diabetes. The system last year launched in a hybrid closed-loop automated insulin delivery system that uses the Dexcom G6 CGM. Kaleido features pulse […]
Medtronic recalls some MiniMed automated insulin delivery systems with battery issues
Medtronic (NYSE:MDT) today announced a voluntary recall warning of battery issues with its MiniMed 600 and 700 series insulin pumps. FDA deemed the recall Class I, the most serious kind. The medtech giant issued a field action starting on July 31, notifying customers to follow built-in alerts for battery status. Customers should contact Medtronic if […]
Qnovia wins FDA nod for nicotine inhaler as smoking cessation therapy
Qnovia announced that the FDA cleared its investigational new drug (IND) application for the RespiRx smoking cessation inhaler (QN-01). RespiRx, a drug-device combination product, offers inhalable nicotine replacement therapy (NRT) to assist in the quitting of smoking. IND clearance allows Qnovia to initiate a Phase 1 trial in the U.S. to determine the pharmacokinetics, safety, […]
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 […]
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 […]
