Medical Technology News | MedTech Dive
WEBMedTech Dive provides medical technology news and analysis for industry professionals. We cover medical devices, diagnostics, digital health, FDA regulation and compliance, imaging, and more.
Abbott and Dexcom are launching the first over-the-counter …
WEBJun 26, 2024 · The first over-the-counter glucose sensors will launch in the U.S. this summer. Dexcom and Abbott received Food and Drug Administration clearance for OTC continuous glucose monitors in March and June, respectively. Although the devices use the same hardware as past CGMs, they’re intended for a different group of users — people …
GE unveils plan to spin off healthcare business - MedTech Dive
WEBNov 10, 2021 · GE on Tuesday announced plans to spin off its healthcare operations in early 2023 as a standalone public company with a focus on precision health. In addition, GE’s renewable energy, power and digital businesses will be spun off in early 2024 as an independent entity, with the remaining company comprising GE’s aviation business.
Synchron brain-computer interface implanted in first 6 US patients
WEBSep 6, 2023 · Synchron, which is developing a brain-computer interface that aims to restore functionality in people with severe paralysis, said Tuesday that six patients have received the implant in the company’s U.S.-based feasibility study. The milestone marks the completion of enrollment in the COMMAND trial, conducted under the first investigational ...
The top medtech trends in 2024
WEBJan 31, 2024 · Experts said M&A, orthopedic procedure backlogs and emerging cardiac markets were among the top trends to watch in the medical device industry this year.
MedTech Mergers & Acquisitions | MedTech Dive
WEBSep 23, 2024 · Edwards continues M&A spree with Genesis’ TAVR tech. Edwards, which has made a series of acquisitions in recent months, is also investing $25 million in Singapore-based Genesis Medtech. By Susan Kelly • Aug. 19, 2024.
FDA wants to require timely updates, patches for legacy devices: …
WEBJun 30, 2021 · This proposal would advance medical device safety by ensuring FDA and the public have information about the cybersecurity of devices. Specifically, FDA seeks to require that devices have the capability to be updated and patched in a timely manner; that premarket submissions to FDA include evidence demonstrating the capability from a …
5 takeaways from the FDA’s list of AI-enabled medical devices
WEBNov 7, 2022 · As medical devices that use artificial intelligence and machine learning appear in more hospitals and imaging labs across the U.S., new data from the Food and Drug Administration show the agency has been fielding more submissions. In 2022 alone, the FDA authorized 91 AI- or machine-learning-enabled medical devices, according to …
Abbott recalls Freestyle Libre 3 sensors due to incorrect glucose ...
WEBJul 26, 2024 · Abbott has recalled a small number of Freestyle Libre 3 sensors distributed in the U.S. in the first half of May, the company said Wednesday. Internal testing found a subset of three lots of the continuous glucose monitor (CGM) sensors may provide incorrect high glucose readings, the company said. The false readings could lead to incorrect ...
Medical Device News | MedTech Dive
WEB5 days ago · Merit Medical inks $210M takeover of Cook’s lead management business. Merit predicts the portfolio, which includes devices used in procedures to remove or replace heart rhythm device leads, will add $40 million a year to its sales. By Nick Paul Taylor • …