Sequel Med Tech‘s twiist automated insulin delivery system obtained an FDA clearance opening up its use to adults with type 2 diabetes. Launched earlier this year for people with type 1 diabetes, the company estimates the agency’s green light adds about 5.5 million people in the U.S. who manage their condition with insulin. Available through […]
FDA
Beta Bionics insulin patch pump scores FDA clearance
Beta Bionics (NASDAQ: BBNX) has claimed an FDA clearance for its first patch pump insulin delivery system, amid plans to roll out an updated diabetes dosing algorithm and the launch of a new CGM partnership with Senseonics. The three-day, wearable Mint carries a 200-unit insulin reservoir as well as a combination of reusable and disposable […]
MannKind closes $50M financing, wins FDA nod for Furoscix auto-injector
MannKind (Nasdaq:MNKD) announced today that it secured $50 million in a private placement and earned a new regulatory nod. In addition to the funding, the company — which also develops inhaled insulin technology — won FDA approval for the Furoscix ReadyFlow auto-injector. MannKind said it entered into a securities purchase agreement in connection with a […]
FDA selects Dexcom for new digital health device pilot
The FDA announced today that it selected Dexcom (Nasdaq:DXCM) as the first manufacturer for a new digital health pilot. Dexcom joins the Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot. It intends to provide a device for use in delivering care expected to be covered by the Centers for Medicare & Medicaid Services […]
Baxter warns on intravascular administration sets
The FDA issued an early alert after Baxter (NYSE:BAX) recommended the removal of certain Duo-Vent intravascular administration sets. Baxter sent all affected customers a letter on June 30, telling them to immediately identify, quarantine and return affected lots. The communication affects lots DR26C27062, DR26D14031 and DR26E13055 of the Duo-Vent solution set and male luer lock adapter. Duo-Vent […]
FDA approves Sanofi anticancer treatment delivered through Enable Injections on-body device
Sanofi announced today that the FDA approved the delivery of its Sarclisa anticancer therapy through the Enable Injections on-body device. Sarclisa (isatuximab-irfc) Escena in combination with standard-of-care regimens received clearance for the treatment of patients with multiple myeloma (MM) across all existing indications of the Sarclisa intravenous (IV) formulation. Approval makes it the first anticancer […]
FDA clears Dexcom Stelo over-the-counter CGM for children
Dexcom (Nadsaq:DXCM) has received FDA clearance for its Stelo over-the-counter (OTC) continuous glucose monitor (CGM) for children. The FDA said in a news release that it cleared Stelo for people two years of age and older who do not use insulin. It became the first OTC CGM system granted clearance in March 2024, initially getting […]
MannKind wins FDA approval for inhaled insulin for children with type 1, type 2 diabetes
MannKind (Nasdaq:MNKD) announced today that it received FDA approval for its Afrezza inhaled insulin powder for children. FDA approval covers use in children and adolescents aged 6 and older with type 1 and type 2 diabetes. Afrezza (insulin human) inhalation powder is a fast-acting insulin formulation delivered through an inhaler device. MannKind engineered the mechanical inhaler […]
Glucotrack submits long-term implantable CBGM for FDA IDE
Glucotrack (Nasdaq:GCTK) announced today that it submitted its implantable continuous blood glucose monitor (CBGM) for FDA IDE. FDA IDE (investigational device exemption) would enable the company to initiate a U.S. clinical study for the fully implantable technology. Rutherford, New Jersey-based Glucotrack’s device features no on-body external component. The company aims to offer it for three years of […]
FDA says Insulet Omnipod 5 recall is serious after 476 device reports, issue is potentially undetectable by user
The FDA says last month’s recall of Insulet (Nasdaq:PODD) Omnipod 5 insulin pump pods has been identified as its most serious type. According to the FDA, such a recall may cause serious injury or death with continued use. Insulet announced on March 12 that it initiated a voluntary medical device correction for specific lots of […]
