Tandem Diabetes Care (NSDQ:TNDM) announced today that Health Canada has approved its t:slim X2 insulin pump with Control-IQ technology. The news comes nearly a year after the U.S. launch of the t:slim X2 with Control-IQ. All in-warranty t:slim X2 pump users in Canada will be able to add Control-IQ technology to their existing pump via a […]
Alaris remediation could cost BD up to $244M
Becton Dickinson (NYSE:BDX) in its most recent fiscal year set aside $244 million to cover future product remediation costs, including the company’s work to fix its problematic Alaris infusion pumps. The Franklin Lakes, N.J.–based company has had shipments of the pumps on hold since early this year, when FDA called for a comprehensive 510(k) submission to […]
Qosina offering SmartSite swabbable needle-free injection sites
Qosina (Ronkonkoma, N.Y.) is touting the variety of SmartSite swabbable needle-free injection sites that it offers. The needle-free injection sites feature an ergonomic design and a smooth, flat top that can be easily disinfected, according to Qosina. Said the company: ” These components are equipped with a valve, that when activated, forms an airtight seal […]
Baxter has a serious infusion pump recall
Baxter (NYSE:BAX) has issued an urgent device correction involving hundreds of thousands of Sigma Spectrum infusion pumps in which it warns that improper cleaning could cause corrosion around the batteries. So far, Baxter has received 16 reports of serious injuries related to the problem. FDA has labeled the recall as Class I, its most serious level. […]
HHS gives Vaxxas $22M to support vaccine patch tech
Vaxxas announced today that it has received a $22 million award from the Biomedical Advanced Research and Development Authority (BARDA) at U.S. HHS to support a clinical study involving the company’s vaccine-delivery patch. The money will mostly pay for a Phase 1 clinical study in which Vaxxas’ high-density micro-array patch (HD-MAP) delivering pandemic influenza vaccine […]
Abbott’s FreeStyle Libre 3 receives CE Mark
Abbott (NYSE:ABT) has won the CE Mark in the European Union for its next-generation FreeStyle Libre 3 continuous glucose monitoring system. Officials at Abbott boast that the Libre 3 technology includes a super small, thin sensor. It’s the size of two U.S. pennies stacked together and able to accurately provide real-time glucose readings over 14 days […]
Could Vaxxas’ tiny patches enable a better COVID-19 vaccine?
Tiny vaccine delivery patches could solve logistical challenges, but they face manufacturing hurdles. Here’s how Vaxxas is trying to overcome them. Merck (NYSE:MRK) and Vaxxas announced earlier this year that the pharmaceutical giant was using Vaxxas’ High Density Microarray Patch (HD-MAP) platform as a delivery platform for a vaccine candidate. Vaxxas did not disclose what […]
3M lays off another 1,700 workers, many related to former drug delivery business
3M (NYSE:MMM) laid off another 1,700 workers during its second-quarter — with many of the jobs related to the company’s divested drug delivery business. The layoff — announced as part of an SEC filing on July 28 — comes after the Maplewood, Minn.–based manufacturing conglomerate said early this year that it would lay off 1,500 workers — though […]
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 […]
U.S. investing $42m to boost BD syringe and needle production
HHS’s Biomedical Advanced Research and Development Authority is helping BD expand operations and manufacturing capacity in Nebraska to boost syringe and needle supplies for an eventual COVID-19 vaccine. Becton Dickinson (NYSE:BDX) said today that the total project will cost $70 million, with BARDA providing $42 million. The company expects the new capacity to be online within […]
