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, […]
Food & Drug Administration (FDA)
Tandem Diabetes Care begins updated software rollout after recall
Tandem Diabetes Care (Nasdaq:TNDM) announced today that it released version 2.8.2 of its Apple iOS t:connect mobile app in the U.S. The company initiated the new software release to remedy issues with prior versions of the technology. Its t:connect mobile app works in conjunction with the t:slim X2 automated insulin pump with Control-IQ technology. Tandem […]
Aptar Group’s Unidose system to deliver neffy nasal epinephrine
Aptar announced today that its Unidose liquid system received FDA approval to deliver ARS Pharmaceuticals’ neffy (epinephrine nasal spray). ARS won FDA approval last week for neffy as an emergency treatment for patients with Type I allergic reactions, including anaphylaxis. It marked a major innovation in epinephrine delivery as the first and only needle-free treatment […]
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 […]
Tandem Diabetes Care to issue app update after more software issues
Tandem Diabetes Care (Nasdaq:TNDM) provided an update on a recall from earlier this year related to an issue with its insulin pump software. In March, the San Diego-based company initiated a recall of Version 2.7 of the Apple iOS t:connect mobile app used in conjunction with the t:slim X2 pump with Control-IQ technology. Tandem recalled […]
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 […]
