Sirtex Medical announced today that it received EU MDR certification to market its SIR-Spheres Y-90 resin microspheres and delivery systems. EU MDR authorization enables Woburn, Massachusetts-based Sirtex to kick off a European launch for its Siros delivery system. Siros offers an intuitive, visual and adaptable solution for physicians to administer SIR-Spheres to liver cancer patients. […]
Regulatory/Compliance
Smiths Medical warns on infusion cassette reservoirs in Europe
ICU Medical’s Smiths Medical unit issued an urgent field safety notice in Europe to warn of issues with certain medication cassette reservoirs. Smiths Medical’s warning pertains to specific models and lots of its 50 mL and 100 mL CADD medication cassette reservoirs. Certain reservoirs may exhibit a weakened weld joint between the medication bag and […]
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 […]
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 […]
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 […]
Abbott recalls some FreeStyle Libre 3 sensors in U.S.
Abbott (NYSE:ABT) announced today that it initiated a voluntary recall for a small number of FreeStyle Libre 3 continuous glucose monitor (CGM) sensors. The company distributed the affected sensors during the first half of May 2024. Abbott did not disclose the number of sensors affected but said the recall affects a small subset of FreeStyle […]
