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 …
Medical Device News - MedTech Dive
WEB2 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.
Neuromod portfolios advance at Medtronic, Boston Scientific, …
WEBJan 15, 2021 · Abbott Laboratories, Boston Scientific and Medtronic all disclosed neuromodulation updates on Thursday, a flurry of activity that is further evidence of the medtech industry’s attempts to innovate in a sector criticized as stagnant just one year ago.. The neuromodulation industry went into 2020 looking to bounce back from a flat 2019 defined by a lack of new products capable of driving growth.
Lazurite and Minnetronix Medical Make New Wireless Surgical …
WEBSep 21, 2022 · Lazurite’s ArthroFree™ System is the first wireless surgical camera system to receive FDA market clearance for arthroscopy and general endoscopy. The ArthroFree System ushers in a new era of wireless surgical visualization in minimally invasive surgery. It is designed to meet the needs of surgeons seeking more-nimble, cutting-edge surgical ...
Medtronic pulls HeartWare HVAD pump from market amid
WEBJun 3, 2021 · Medtronic abruptly pulled its HeartWare HVAD pump system from the market Thursday after a slew of Class I recalls and numerous reports of patient injuries and deaths associated with the device. The medtech cited ongoing device failures and “ a growing body of observational clinical comparisons indicating a higher frequency of neurological ...
Abbott and Dexcom are launching the first over-the-counter …
WEBJun 26, 2024 · The new devices could allow the companies to reach about 25 million people in the U.S. with Type 2 diabetes who don’t take insulin, 15 million people who have been diagnosed with pre-diabetes and an estimated 85 million people who have undiagnosed pre-diabetes, William Blair analyst Margaret Kaczor Andrew said in an interview.
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 ...
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.
Noah Medical lung biopsy robot exceeds expectations in first-in …
WEBSep 1, 2023 · Dive Brief: Noah Medical said its surgical robot for diagnosing lung cancer demonstrated it could successfully navigate to peripheral pulmonary nodules in its first-in-human trial. The study, dubbed FRONTIER, targeted 19 nodules using the company’s Galaxy robotic system. Preliminary results, presented at the American Association of ...
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 ...
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