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PSN Labs called for a jury trial, claiming Philips is attempting to deflect attention away from its own “failures, negligence, concealment and recklessness.”. MedTech Dive provides medical technology news and analysis for industry professionals. We cover medical devices, diagnostics, digital health, FDA regulation and compliance, imaging ...
FDA finalizes guidance on how clinical decision support software is ...
Sep 28, 2022 · Dive Brief: The Food and Drug Administration has published final guidance on determining whether clinical decision support software is considered a medical device.; The final text diverges significantly from the draft released in 2019, omitting sections on the International Medical Device Regulators Forum’s (IMDRF) risk categorization, and completely rewriting other parts of the document.
COVID-19 MedTech News | MedTech Dive
May 3, 2024 · Cue Health wins first non-emergency authorization for COVID test, days after Goldman downgrade. The FDA’s marketing authorization for Cue’s COVID-19 molecular test could boost consumer access, but the company faces strong competition from more established diagnostic firms. By Peter Green •June 7, 2023. Courtesy of Cue Health Press Kit.
Dexcom’s G7 glucose monitor wins awaited FDA clearance
Dec 8, 2022 · The device, which Dexcom plans to start selling in the U.S. early next year, is cleared for people with Type 1 and Type 2 diabetes, as well as gestational diabetes. Published Dec. 8, 2022. Elise Reuter Reporter. Dexcom won FDA approval to begin selling its G7 continuous glucose monitor in the U.S. later this year. (Shown here with an Apple Watch).
Boston Scientific resubmits Silk Road merger filing, giving FTC …
Aug 16, 2024 · Dive Brief: Boston Scientific has resubmitted a federal filing for its proposed acquisition of Silk Road Medical to provide more time for regulatory review.; On Aug. 9, Boston Scientific decided to withdraw and refile its Premerger Notification Report Form after both companies submitted their respective merger filings on July 10, according to a Securities and Exchange Commission filing from ...
Sanofi taps Abbott, Novo adds Medtronic for CGM integrations
Sep 16, 2019 · Medtronic and Abbott each announced new connected insulin pen integrations for their continuous glucose monitor systems Monday. Both collaborations are non-exclusive. Medtronic’s CGM devices will integrate with future Novo Nordisk insulin pens under a new agreement with the Danish pharma. Abbott partnered with Sanofi to make its FreeStyle ...
Boston Scientific pulls forward expected approval for Farapulse …
Jan 3, 2024 · Dive Brief: Boston Scientific has reset expectations for the approval of its Farapulse pulsed field ablation (PFA) system, pulling the anticipated decision date forward to the first quarter of 2024.; In October, Boston Scientific told investors to expect the Food and Drug Administration to approve the device in the second half of 2024. An …
Medtronic receives CE mark for CGM sensor, boosting
Sep 25, 2023 · Dive Brief: Medtronic has received a CE mark for its Simplera continuous glucose monitor, bringing a challenger to Abbott and Dexcom devices in the European Union.; The device, Simplera, is the successor to the Guardian 4 sensor. Medtronic has made the sensor smaller and eliminated the need to tape it in place to create a CGM that more closely resembles the market-leading devices from its ...
Abbott ramps up Libre 3 production amid shortages
Sep 20, 2024 · Abbott received FDA clearance for its FreeStyle Libre 3 continuous glucose monitor in May 2022. The company is ramping up production as some people face delays due to high demand. Permission granted by Abbott Laboratories. Some people who use a Freestyle Libre 3 glucose sensor are facing delays getting their prescriptions filled.
Roche to take on Abbott, Dexcom with its first CGM
Mar 7, 2024 · Dive Brief: Roche shared details of its plans to enter the continuous glucose monitor (CGM) market, unveiling the Accu-Chek Smartguide at the Advanced Technologies and Treatments for Diabetes conference in Florence, Italy. On Thursday, the company released data on a 14-day sensor that could compete with Abbott and Dexcom for the CGM market.