Medical Technology News | MedTech Dive
WEBThe European Commission lacked oversight authority to examine the proposed sale of a cancer-detection company to biotech company Illumina, the court found. MedTech Dive provides medical technology news and analysis for industry professionals. We cover medical devices, diagnostics, digital health, FDA …
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.
Boston Scientific’s spinal cord stimulators approved for non …
WEBFeb 7, 2024 — Boston Scientific has won approval for its Wavewriter spinal cord stimulator (SCS) systems in non-surgical back pain (NSBP). The U.S. Food and Drug Administration approval expands the label of the Wavewriter systems to cover the treatment of chronic low back and leg pain in people without prior back surgery. The …
FDA’s plan to expand device surveillance faces challenges, GAO finds
WEBAug 21, 2024 — Dive Brief: The Food and Drug Administration has taken steps to establish an active postmarket surveillance system to monitor medical device safety but has faced two key challenges, according to a recent government report.; A Government Accountability Office (GAO) investigation, published Aug. 15, found the FDA plans to start active surveillance for two device types by December and expand the ...
The top medtech trends in 2024 | MedTech Dive
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. Growing procedure volumes and remaining backlogs for certain surgeries could propel device companies to a successful 2024. JohnnyGreig via Getty Images.
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 ...
5 takeaways from the FDA’s list of AI-enabled medical devices
WEBNov 7, 2022 — MedTech Dive analyzed FDA data on all of the AI- and machine-learning-enabled devices the agency has authorized to date. Here are five takeaways on the rise of these devices. 1. The number of AI-enabled medical devices has surged in the last five years. Number of approvals and clearances by the Food and Drug Administration per year.
MedTech Mergers & Acquisitions | MedTech Dive
WEBSep 23, 2024 — 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 • …
iRhythm analysis shows savings from patients wearing Zio XT …
WEBNov 7, 2022 — An analysis presented at the American Heart Association’s 2022 Scientific Sessions demonstrated the cost effectiveness of using iRhythm’s Zio XT patch to screen for atrial fibrillation. The results showed an incremental cost-effectiveness ratio of $17,000 per quality-adjusted life year gained, the academic standard for measuring how well ...
How AI and machine learning are changing prosthetics
WEBMar 29, 2019 — Driving demand are aging populations and rising incidence of vascular diseases, as well as developments in artificial intelligence and machine learning. Advanced materials such as silicone and urethanes are also resulting in lighter-weight prosthetics with “memory” to respond to changes in pressure. Among those competing in the space are ...