Medtronic (NYSE:MDT) today announced a voluntary recall warning of battery issues with its MiniMed 600 and 700 series insulin pumps. FDA deemed the recall Class I, the most serious kind. The medtech giant issued a field action starting on July 31, notifying customers to follow built-in alerts for battery status. Customers should contact Medtronic if […]
Food & Drug Administration (FDA)
Qnovia wins FDA nod for nicotine inhaler as smoking cessation therapy
Qnovia announced that the FDA cleared its investigational new drug (IND) application for the RespiRx smoking cessation inhaler (QN-01). RespiRx, a drug-device combination product, offers inhalable nicotine replacement therapy (NRT) to assist in the quitting of smoking. IND clearance allows Qnovia to initiate a Phase 1 trial in the U.S. to determine the pharmacokinetics, safety, […]
Fresenius Kabi recalls and removes some Ivenix infusion pump administration sets from market
The FDA issued a notice outlining a serious recall of Ivenix infusion pump administration sets from Fresenius Kabi. This recall involves removing certain devices from where they are used or sold. The FDA identified it as the most serious type as it may cause serious injury or death. Fresenius Kabi recalled certain lots of the […]
Senseonics wins FDA nod for 365-day implantable CGM
Senseonics (NYSE:SENS) announced today that it received FDA clearance for its next-generation Eversense 365 CGM system. Eversense 365, an implantable continuous glucose monitor (CGM), becomes the world’s first 365-day CGM system, according to the company. Its indications cover people with type 1 and type 2 diabetes aged 18 years and older. The system also received clearance […]
Embecta wins FDA clearance for disposable insulin patch pump
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 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, […]
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 […]
