The FDA has posted a notice that an Insulet recall related to Omnipod Dash batteries is Class I, its most serious level. Insulet recently issued a voluntary global safety notice to warn about battery problems. The Omnipod Dash is Insulet’s previous-generation insulin pump. The company since launched its FDA-cleared and CE-marked Omnipod 5 next-generation automated insulin delivery system. The […]
Eli Lilly to start rollout of Tempo personalized diabetes management platform
Eli Lilly and Co. (NYSE: LLY) recently announced it will soon roll out its Tempo personalized diabetes management platform in the U.S. The pharma giant described Tempo as its first connected platform. It includes three components: the Tempo Smart Button, a compatible TempSmart app, and the prefilled Tempo Pen insulin pen. The goal is personalized […]
Senseonics down on tightened guidance — but it hits milestone on 365-day implantable CGM
Senseonics (NYSE American: SENS) reported a third-quarter revenue beat, but its stock took a hit amid tightened full-year revenue guidance. The Germantown, Maryland–based maker of implantable continuous glucose management systems lost $60.4 million, or 13¢ per share, off $4.6 million in revenue for the quarter ended Sept. 30, 2022. In contrast, Senseonics saw a profit […]
Abbott beats The Street in Q3 on stronger medical device sales
Abbott (NYSE: ABT) today reported third-quarter results that beat the consensus forecast on Wall Street, upping its full-year EPS guidance. Investors, however, seemed to react negatively to the company’s year-over-year decline in earnings and sales in Q3. The Abbott Park, Illinois–based life science tech company especially benefitted from the U.S. launch of the next-gen FreeStyle […]
Investors sue Medtronic over insulin pump problems
Add a potential class action shareholder lawsuit to the challenges Medtronic (NYSE: MDT) is facing over its Diabetes business. The law firm of Kessler Topaz Meltzer & Check announced last week that it has sued the medtech giant in U.S. District in Minnesota, claiming securities fraud over how it disclosed insulin pump problems. The initial […]
Shareholder lawsuit over BD’s Alaris pumps recall moves forward
A federal judge in New Jersey is allowing part of a shareholder lawsuit to proceed against BD (NYSE: BDX) and CEO Thomas Polen over how they communicated company performance amid increasingly serious Alaris infusion pump problems. In an Aug. 11 opinion, Judge Stanley R. Chesler dismissed Industriens Pensionsforsikring’s claims against former BD CEO Vincent Forlenza […]
Abbott will spend $450M to up FreeStyle Libre production in Ireland
Abbott (NYSE:ABT) will spend €440 million ($450 million) to expand its operations in Ireland, the country’s government announced today. The investment involves the creation of a new 250,000-square-foot manufacturing facility in Kilkenny and a further investment in the company’s Donegal Diabetes Care site. The investment will add 1,000 new jobs between the sites. The new […]
Tandem Diabetes Care wins FDA clearance for insulin dosing via smartphone app
Tandem Diabetes Care (NASDAQ:TNDM) today announced FDA clearance of bolus insulin dosing on the t:slim X2 insulin pump using the t:connect mobile app. Company officials said the t:connect mobile app is now the first FDA-cleared smartphone app for insulin delivery on both the iOS and Android operating systems. Tandem Diabetes Care plans to roll out […]
TriMas completes purchase of Omega Plastics
TriMas (NASDAQ: TRS) announced today that it has completed its acquisition of medical device components maker Omega Plastics. The financial terms of the deal were not disclosed. Omega (Clinton Township, Michigan) expects to bring in $18 million in revenue in fiscal year 2021. Omega Plastics boasts core injection molding capabilities, an ISO Class 8 clean […]
ICU Medical’s Smiths Medical acquisition remains on track
ICU Medical (NASDAQ:ICUI) is a step closer to acquiring Smiths Medical after clearing a shareholders vote at Smiths’ British parent company, the Smiths Group. Almost all of the nearly 327 million Smiths Group shareholders voting on November 17 approved the $2.35 billion buy. Get the full story on our sister site Medical Tubing + Extrusion.
