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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 regulation and compliance, imaging, …
Intuitive secures FDA clearance for lung biopsy robot featuring …
WEBJul 1, 2022 · Intuitive received FDA clearance for the Ion in 2019. With its 3.5 mm catheter, the system is designed to enable physicians to navigate through small airways and access hard-to-reach nodules. In doing so, Ion could enable early diagnosis of lung cancer, improving patient outcomes. Last year, Intuitive placed 93 Ion systems, growing its total ...
EU task force posts guidance on significant IVDR changes to …
WEBMay 6, 2022 · Dive Brief: The Medical Device Coordination Group task force released guidance on the changes that in-vitro diagnostic manufacturers can make to their products under the transitional provisions of the new regulation.; Manufacturers can place in-vitro diagnostics on the market with certificates issued under the old directive for a time after …
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.
Edwards has edge over Medtronic in TAVR registry studies
WEBNov 19, 2019 · Dive Brief: Two registry studies have linked Edwards Lifesciences’ transcatheter aortic valve replacement (TAVR) system to better outcomes than Medtronic’s rival device. The studies, which were published in the Circulation journal on Saturday, describe the use of French registry data to compare Edwards’ balloon-expandable …
FDA approves neuromodulation device for heart failure
WEBAug 19, 2019 · FDA on Friday announced approval of an implantable device that electrically stimulates the baroreceptors of the carotid artery to reduce heart failure symptoms in advanced heart failure patients. CVRx’s Barostim Neo device is intended for use in patients who have not been helped by medical therapy or who are not candidates for cardiac ...
Abbott, Tandem launch new hybrid closed-loop insulin delivery …
WEBJan 8, 2024 · Dive Brief: Tandem Diabetes Care integrated its t:slim X2 insulin pump with Abbott’s Freestyle Libre 2 Plus sensor, paving the way for the first automated insulin delivery system available to Abbott’s U.S. customers.; The launch is a “major milestone” for Abbott, as Tandem’s device is “the first hybrid closed-loop system to integrate with Libre …
Major conglomerates 3M, GE, Philips bet on healthcare
WEBJan 30, 2020 · Major global conglomerates like 3M and Philips have taken steps to increase focus on healthcare in recent years, shedding units covering other industries while buying additional medical assets in the belief the aging population will drive growth. GE took a different path, initially planning to spin off its healthcare unit (like Siemens did with ...
Edwards continues M&A spree with Genesis’ TAVR tech
WEBAug 19, 2024 · Edwards, which has made a series of acquisitions in recent months, is also investing $25 million in Singapore-based Genesis Medtech. Published Aug. 19, 2024. By. Susan Kelly Reporter. Edwards Lifesciences is acquiring a transcatheter aortic valve replacement (TAVR) system from Genesis Medtech. Edwards Lifesciences. Listen to the …
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 …