Medtronic (NYSE:MDT) announced today that it received CE mark approval for its new Simplera continuous glucose monitor (CGM). The all-in-one, disposable CGM features a simple, two-step insertion process for people with diabetes using multiple daily injections (MDI). Medtronic’s newest no-fingerstick sensor eliminates the need for overtape, too. It seamlessly integrates with the InPen smart insulin […]
Regulatory/Compliance
GLP-1 startup i2o looks to revive diabetes drug-eluting implant from Intarcia
i2o Therapeutics says it acquired the diabetes-treating assets of one-time medtech unicorn Intarcia Therapeutics. The Boston-based company acquired and integrated Intarcia’s proprietary assets and made a big personnel move. With CEO Ravi Srinivasan moving onto other opportunities, i2o named Kurt Graves as chair, president and CEO. Graves previously served as executive chair of the i2o […]
FDA clears VVT Medical varicose veins treatment device
VVT Medical announced in recent months that FDA has cleared its ScleroSafe platform, which delivers endovenous chemical ablation to treat superficial varicose veins. Kfar Saba, Israel–based VVT Medical says it specifically created ScleroSafe to provide efficient, non-thermal, non-tumescent treatment and management of varicosities in superficial veins. Its inverse-action dual syringe injects the ECA substance into […]
FDA clears new infusion pump and software from ICU Medical
ICU Medical (Nasdaq:ICUI) announced today that the FDA granted 510(k) clearance to its Plum Duo infusion pump with LifeShield infusion safety software. The San Clemente, California-based company plans to make the pump and software available to U.S. customers in early 2024. Plum Duo, the latest addition to the ICU Medical infusion device portfolio, builds on […]
Welldoc gets FDA nod for CGM-guided insulin bolus dosing software
Welldoc announced today that it won the 11th FDA 510(k) clearance for its BlueStar digital diabetes management platform. The clearance comes just a week after BlueStar received its 10th FDA clearance for using connected insulin dosing data in personalized bolus insulin dosing recommendations. Welldoc’s newest clearance enables BlueStar to provide bolus insulin dose recommendations based […]
BioCorRx submits implantable opioid use disorder treatment to FDA for expanded access
BioCorRx announced today that it submitted to the FDA an expanded access program application for its BICX104 implantable naltrexone pellet. BICX104, a biodegradable implantable pellet, treats opioid use disorder (OUD). The expanded access program would enable the treatment to reach eligible patients before full FDA approval. The FDA program provides access to products before approval […]
FDA clears Welldoc BlueStar for personalized bolus insulin dosing recommendations
Welldoc announced today that it received the 10th FDA 510(k) clearance for its BlueStar diabetes digital health solution. The latest regulatory nod enables BlueStar to use connected insulin dosing data in personalized bolus insulin dosing recommendations. Columbia, Maryland-based Welldoc aims to make this enhanced functionality available commercially in 2024. “The receipt of our 10th 510(k) […]
Baxter warns on some infusion pumps due to potential false alarms
Baxter (NYSE:BAX) issued an urgent medical device correction for some Spectrum V8 and Spectrum IV infusion pumps in the U.S. The FDA later issued a notice identifying the recall as Class I, the most serious kind. Baxter recalled 22,769 devices in total. Affected pumps in the U.S. and Puerto Rico received upgrades to software versions […]
B. Braun recalls some two-piece syringes due to potential packaging barrier damage
B. Braun issued an urgent field safety notice in Europe related to potential issues with certain two-piece syringes. The company’s notice said it decided to proactively recall a batch combination of the syringes. B. Braun identified a number of batches of its Exadoral, Henke-JECT, Norm-Ject and Injekt devices. In the course of postmarket surveillance and […]
FDA clears updated BD Alaris infusion system after long-term commercial hold
BD (NYSE:BDX) announced today that the FDA granted 510(k) clearance for its updated Alaris infusion system. Shares of BDX closed out Friday evening priced at $264.84 each. They ticked up significantly after market close on the back of the Alaris news, rising 5.9% to $280.40 apiece. Clearance enables both remediation and a return to full […]