The FDA issued another Class I recall designation for the BD Alaris from Becton Dickinson (NYSE:BDX), this time for potentially incorrect displays. Recalled products include the BD Alaris syringe module (model 8110) and BD Alaris PCA module (model 8120), and the BD Alaris syringe/PCA sizer sensor replacement kit (P/N 122786). Affected products related to the infusion […]
BD has a serious recall of some Alaris System infusion pumps with stuck keys
The FDA announced today that the August recall of a Becton Dickinson (NYSE:BDX) Alaris PC unit is Class I, the most serious kind. Initiated on Aug. 4, 2020, the recall pertains to the BD Alaris PC unit 8015 and five affected keypad replacement kits manufactured between April 7, 2017 and June 15, 2020 and distributed between […]
BD says 3 serious issues related to Alaris recall
Becton Dickinson (NYSE:BDX) today offered an update confirming three separate issues related to the recall of its BD Alaris infusion pumps. Three situations described in the recall, which was announced on June 30, were designated as FDA Class I recalls (the most serious kind), meaning that there is reasonable probability that use of the product will […]
Smiths Medical has a serious infusion pump recall
Smiths Medical announced that it has become aware of an issue in which certain Medfusion syringe pumps may not operate as expected. Minneapolis-based Smiths Medical said in a news release that certain Medfusion 3500 and 4000 syringe pumps with specific firmware versions may provide over-delivery or under-delivery of a bolus or loading dose when one […]
Medtronic, Tandem Diabetes Care bury the hatchet on potential IP disputes
Two major insulin pump makers — Medtronic (NYSE:MDT) and Tandem Diabetes Care (NSDQ:TNDM) — announced today that they’ve inked a non-exclusive patent cross-license agreement related to diabetes treatment tech. The companies said the agreement will allow them to focus on innovation while avoiding the distraction of potential legal disagreements. The deal could be but another example of […]
Abbott, Tandem seal deal to combine CGM, insulin delivery tech
Abbott (NYSE:ABT) and Tandem Diabetes Care (NSDQ:TNDM) announced today that they have completed their agreement to combine the former’s glucose-sensing technology with the latter’s insulin delivery systems. The deal, announced in October, will combine Abbott’s Freestyle Libre CGM with Tandem’s t:slim X2 pump to monitor glucose without fingersticks. The agreement covers the technical development of device integration and associated […]
Tandem Diabetes Care acquires Sugarmate mobile app
Tandem Diabetes Care (NSDQ:TNDM) said today that it has purchased Sugarmate — as mobile app that helps people better manage their diabetes. Financial terms of the deal were not disclosed. Nearly 30,000 people relying on insulin pumps or multiple daily injections presently use the Sugarmate app. Get the full story on our sister site Drug Delivery […]
Abbott, Medtronic go head-to-head at ADA conference
Major medtech companies vied for the biggest news splash at this year’s annual meeting of the American Diabetes Association, announcing promising results from studies of patients who used their latest diabetes technology. The virtual 80th Annual American Diabetes Association Virtual Scientific Sessions, which runs through Tuesday, so far has featured news out of Abbott (NYSE:ABT) and Medtronic (NYSE:MDT) and several smaller […]
Medtronic touts results of latest MiniMed studies at ADA
The latest generation of the Medtronic (NYSE:MDT) MiniMed insulin pump met both safety and glycemic endpoints in a study presented today at the American Diabetes Association’s virtual annual conference. The MiniMed 780G closed-loop system is indicated for treating Type 1 diabetes in people aged 7 to 80 years old. It is designed to automate the delivery […]
Baxter wins CE Mark for EVO IQ syringe system
Baxter (NYSE:BAX) announced that it received regulatory approval in Europe and Australia for its Evo IQ syringe infusion system. With CE Mark approval in Europe and a nod from Australia’s Therapeutic Goods Administration (TGA), the company expects hospitals in the United Kingdom, Ireland, Greece, Australia and New Zealand to be among the first to receive the […]
BD’s CME America suspends distribution of recalled infusion pumps
Becton Dickinson (NYSE:BDX) subsidiary CME America notified customers that it is suspending distribution of its recalled BodyGuard infusion pump system. In March, the FDA designated the CME America BodyGuard microset infusion sets recall as Class I — its most serious level — after complaints of under-infusion related to the sets. CME America initiated the U.S. recall […]
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