Embecta (Nasdaq:EMBC) announced today that it received FDA 510(k) clearance for its proprietary disposable insulin delivery system. The open-loop system is indicated for adults who require insulin to manage diabetes, including both type 1 and type 2 diabetes. It features a tubeless design with a 300-unit insulin reservoir, informed by feedback from people with type […]
FDA
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, […]
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 […]
ARS Pharmaceuticals wins first FDA approval for needle-free, nasal epinephrine
ARS Pharmaceuticals (Nasdaq:SRPY) announced that it received FDA approval for its neffy (epinephrine nasal spray) 2 mg for treating of Type I allergic reactions. Approval includes the treatment of anaphylaxis, with the indication covering adults and children who weigh ≥30 kg (66 lbs.). It marks a major innovation in epinephrine delivery as the first and […]
FDA approves first opioid overdose reversal auto-injector from Purdue Pharma
Purdue Pharma announced that the FDA approved its new drug application (NDA) for the Zurnai (nalmefene injection) auto-injector. The single-dose auto-injector delivers 1.5 mg of nalmefene hydrochloride per actuation. It marks the approved first nalmefene hydrochloride auto-injector for the emergency treatment of known or suspected opioid overdose. The agency approved the first nasal spray formulation […]
Medtronic wins FDA nod for next-gen Simplera CGM
Medtronic (NYSE:MDT) announced today that it received FDA approval for its Simplera continuous glucose monitor (CGM). It marks another boost for Medtronic’s CGM portfolio, which will also include an integrated CGM offering through a collaboration with Abbott announced today. Simplera, the company’s first disposable, all-in-one CGM, comes in at half the size of previous Medtronic […]
FDA says Alcyone Therapeutics can continue study of drug delivery implant
Alcyone Therapeutics announced today that the FDA approved continued enrollment in a study of its ThecaFlex DRx drug delivery system. The company can continue enrolling in the PIERRE FDA investigational device exemption study for the implantable medical device. It evaluates the system, comprised of a subcutaneous port and intrathecal catheter system. This system provides chronic […]
FDA concerns push Novo Nordisk once-weekly insulin timeline beyond 2024
Novo Nordisk announced that the FDA issued a Complete Response Letter (CRL) related to its once-weekly insulin submission. In the CRL, the FDA made requests for Novo Nordisk to complete before it can complete its review of a Biologics License Application (BLA). As a result, the insulin maker said it does not expect to fulfill […]
CeQur wins FDA nod for mealtime insulin delivery device
CeQur announced recently that the FDA granted 510(k) clearance for its Simplicity system for an extended wear duration. Clearance extends the wear time for the wearable mealtime insulin delivery patch from three to four days. It marks a significant advancement for what the company says is the longest wearable insulin delivery patch, which provides diabetes […]
