Medical Technology News | MedTech Dive
WEBUFP to buy device component maker AQF Medical, extending deal spree. AQF makes foam and thermoplastic components for use in medical devices and packaging. MedTech Dive provides medical technology news and analysis for industry professionals. We cover medical devices, diagnostics, digital health, FDA …
CGM, insulin pump players look to 2021 as watershed year for …
WEBJan 29, 2021 · Now, Wall Street and industry see 2021 as a watershed moment for diabetes technology. Along with plans to expand into new markets, nearly every major player in the CGM and insulin pump space have product launches this year, one of which J.P. Morgan said could be the year's biggest for industry. As the CGM and insulin pump markets gain momentum, companies like Dexcom and Insulet point to a ...
Thermo Fisher will buy The Binding Site for $2.6B to gain specialty ...
WEBOct 31, 2022 · Dive Brief: Thermo Fisher said it agreed to acquire U.K.-based diagnostics firm The Binding Site Group for 2.25 billion pounds ($2.6 billion). Binding Site makes two blood tests for multiple myeloma called Freelite and Hevylite.
Dexcom CEO on G7's global launch, COVID-19 slowing new …
WEBJan 18, 2022 · The CEO spoke to MedTech Dive about other expectations for Dexcom in 2022, including international expansion strategies, further launching the Dexcom ONE product in Europe and how the CGM maker will approach its G7 launch in Europe and, possibly, the U.S.
Medical Device News - MedTech Dive
WEB3 days ago · Many FDA-authorized AI devices lack validation data. About 43% of all AI-enabled devices cleared or approved by the FDA through 2022 were missing validation data, and only 28% were tested prospectively, according to a Nature Medicine study. By Elise Reuter • Sept. 9, 2024.
FDA starts review after study finds Boston Scientific's Watchman is ...
WEBSep 28, 2021 · An analysis published in JAMA Cardiology last month of a U.S. registry of almost 50,000 patients suggested Watchman is riskier for women than men. On multiple measures, women suffered more adverse events than men. The rate of adverse events in women was 6.3%, compared to 3.9% in men. The study found similar differences in the rates of major ...
Medtronic snags first pulsed field ablation approval in US
WEBDec 14, 2023 · Medtronic has gained the first approval from the Food and Drug Administration for a pulsed field ablation (PFA) system to treat atrial fibrillation (AFib), pulling ahead of other medtech companies in the race to bring the technology to the U.S. market. The treatment approach has garnered attention as a safer alternative to radiofrequency and ...
Varian sold to Siemens Healthineers in $16.4B all-cash deal
WEBAug 2, 2020 · Dive Brief: Siemens Healthineers will buy radiation oncology systems and software maker Varian Medical in an all-cash deal valued at $16.4 billion, the companies announced Sunday, confirming a Bloomberg report Saturday.; The biggest deal in medtech so far this year gives Siemens Healthineers, which formally spun out of the German conglomerate via a 2018 IPO, a suite of cancer treatment ...
Military-focused abdominal trauma foam earns FDA breakthrough …
WEBJul 1, 2019 · Dive Brief: FDA granted its second breakthrough device designation in as many weeks for an expandable foam to rapidly control severe internal bleeding in trauma patients. The breakthrough program expedites regulatory review of new medical technologies to treat and diagnose life-threatening conditions. The agency awarded the latest breakthrough ...
CMS finalizes notice on Medicare coverage for breakthrough devices
WEBAug 8, 2024 · Rebecca Pifer/MedTech Dive. The Centers for Medicare and Medicaid Services shared a final notice on Wednesday for a new pathway to cover breakthrough medical devices. The pathway, called Transitional Coverage for Emerging Technologies (TCET), is intended to expedite Medicare coverage of new medical devices. On average, it takes about five years ...