By Senior Editor Danielle Kirsh and Associate Editor Sean Whooley From pulsed field ablation to diabetes, surgical robotics, and much more, we see a number of significant medical device launches on the horizon in 2024. Pulsed field ablation news took over at the end of 2023 and the start of 2024, with Medtronic and Boston […]
Drug-Device Combinations
Ypsomed, ten23 health collab on YpsoDose patch injector
Ypsomed announced today that it entered into a partnership with ten23 health to commercialize its YpsoDose wearable injector. Burgdorf, Switzerland-based Ypsomed designed YpsoDose for the subcutaneous self-injection of large-volume doses. ten23 health, a Swiss CDMO, offers drug development, filling and device assembly expertise to contribute to the product offering. The strategic collaboration sees both parties […]
Cook Medical wins DOD contract for drug-eluting stents
Cook Medical announced today that the U.S. Dept. of Defense (DOD) awarded it an ECAT contract for implantable medical devices. The contract includes implantable vascular medical devices like the Zilver PTX drug-eluting peripheral stent. It also applies to the Zenith aortic endografts and associated interventional devices for treating vascular disease. Cook Medical said in a […]
OM1, Medtronic partner on drug-eluting implant study
OM1 today announced positive results from its partnership with Medtronic (NYSE:MDT) evaluating the Propel corticosteroid-eluting implants. The Propel bioabsorbable implant family came to Medtronic through its acquisition of IntersectENT in 2022. OM1 and Medtronic partnered on their study to focus on healthcare resource use and long-term outcomes in patients with chronic rhinosinusitis (CRS) who underwent […]
Insulet applauds as UK begins artificial pancreas rollout
Insulet (Nasdaq:PODD) expressed its excitement today as a new diabetes initiative in the UK could bring artificial pancreas’ to many with diabetes. NHS England said tens of thousands of children and adults with type 1 diabetes in the country will receive an artificial pancreas. The initiative includes hybrid closed-loop automated insulin delivery systems like Insulet’s […]
Smiths Medical warns on some infusion pumps
An urgent field safety notice issued in Europe warns of software issues with some CADD-Solis ambulatory infusion pumps made by Smiths Medical. The ICU Medical unit corrected some issues in previous software updates but some problems persist. For starters, according to the communication, the infusion pump may not alarm for an upstream occlusion. This issue […]
InfuTronix has a Class I infusion pump recall
InfuTronix recently announced a voluntary recall of the Nimbus ambulatory infusion pump system from the U.S. market. Following the voluntary removal, the FDA deemed the recall Class I, the most serious kind. It affects 52,328 devices in the U.S. in total. The recall extends to the Nimbus II PainPro, Nimbus II Flex, Nimbus II Plus, […]
Tandem Mobi automated insulin pump wins FDA nod for expanded pediatric use
Tandem Diabetes Care (Nasdaq:TNDM) announced that the FDA cleared its Mobi insulin pump for an expanded pediatric indication. The FDA approved Tandem’s 510(k) application for the use of Mobi in individuals two years of age and older. In an SEC filing dated April 1, the company said the decision came through on March 21. Previously, […]
FDA clears Baxter Novum IQ large-volume infusion pump, Dose IQ safety software
Baxter (NYSE:BAX) announced today that the FDA granted 510(k) clearance for its Novum IQ large-volume infusion pump (LVP) with Dose IQ safety software. Clearance adds the LVP to the Novum IQ platform, which already includes the Baxter syringe infusion pump (SYR). It enables clinicians to utilize a single, integrated system across a variety of patient […]
Tandem Diabetes Care taps miniaturization and automation for its latest systems
Tandem Diabetes Care (Nasdaq:TNDM) EVP and Chief Strategy Officer Elizabeth Gasser didn’t exactly plan for the whirlwind past year or so. In the space of about two months, Tandem announced continuous glucose monitor (CGM) integration with the latest-generation technology from Dexcom and Abbott, launched its Tandem Source diabetes management platform and began the rollout of […]
Ypsomed sells pen needle, blood glucose monitor business to focus on insulin pump
Ypsomed announced today that it agreed to sell its pen needle and blood glucose monitoring (BGM) businesses to Medical Technology and Devices (MTD). With the transfer of these businesses, Ypsomed plans to focus its diabetes care business on insulin pumps. Specifically, it looks to the further development and marketing of the mylife Loop automated insulin […]