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 […]
Food & Drug Administration (FDA)
Abbott wins FDA authorization for dual glucose-ketone sensor
Abbott (NYSE:ABT) announced today that the FDA has authorized its dual glucose-ketone sensing technology for people with diabetes. The authorization of the Libre Duo 10 Day system — which provides 10 days of wear time — comes three months after the company reported a CE mark in the EU for the Libre Duo and Libre […]
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 […]
Abbott gets FDA nod for longer length Esprit BTK drug-eluting scaffold
Abbott (NYSE:ABT) announced today that the FDA approved the longer length (76 mm) Esprit BTK drug-eluting scaffold system. The longer Esprit BTK system received approval for the treatment of chronic limb-threatening ischemia (CLTI), a severe form of peripheral artery disease (PAD). CLTI can cause extreme pain, open wounds that don’t heal and, in some cases, […]
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 […]
Dexcom launches enhanced Stelo app
Dexcom (Nadsaq:DXCM) today announced the launch of its fully reimagined Stelo over-the-counter (OTC) sensor app experience. San Diego-based Dexcom plans to formally begin the new app rollout in July for Apple iPhone and Android users in the U.S. The company At ADA 2026, Dexcom said it planned to offer select users the opportunity for early […]
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 […]
Dexcom to acquire wellness tracking company Nutrisense, launch enhanced Stelo app
Dexcom (Nasdaq:DXCM) announced today that entered into an agreement to acquire Nutrisense and shared plans for upgrades to its Stelo sensor. San Diego-based Dexcom expects its deal to buy Nutrisense for an undisclosed amount in the coming weeks. With the acquisition, the continuous glucose monitor (CGM) maker plans to further expand its ability to support […]
