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
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.
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.
Smith & Nephew returns to growth as US hip sales surge
WEBApr 29, 2021 · Smith & Nephew returned to growth in the first quarter as the resurgence of the U.S. hip business offset continued weakness in other parts of the company. The pandemic set back the turnaround effort at Smith & Nephew but, like other companies reliant on elective procedures for sales, the first quarter featured signs of a recovery.
MedTech Mergers & Acquisitions | MedTech Dive
WEB6 days ago · Getinge to buy Paragonix organ-preserving tech for up to $477M. Getinge will pay $253 million in cash at closing, with additional payments expected to be made between 2024 and 2026 if certain milestones are met. By Ricky Zipp • Aug. 23, 2024.
FDA flags 428 spinal cord stimulator patient deaths, urges more …
WEBSep 4, 2020 · The 107,728 MDRs received by FDA in the four-year period following July 27, 2016, include reports of 428 individual deaths of patients implanted with SCSs between 2005 and 2020. Almost one-third of cases where times to event were available happened in the 30 days after implantation. Many of the patients …
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 ...
FDA Breakthrough Devices Program nears 300 designations
WEBPublished May 27, 2020. By. Susan Kelly Reporter. Jacob Bell. FDA has granted 50 breakthrough device designations so far this year, an agency spokesperson told MedTech Dive on Tuesday, bringing the total number given throughout the program’s history to 298. The Breakthrough Devices Program, which emerged from the …
Diabetes tech companies continue 2020's success with Q1 growth ...
WEBMay 12, 2021 · The run of success for diabetes tech in 2020 carried over into the beginning of 2021 as continuous glucose monitor and insulin pump makers grew revenues and product volumes over last year's marks.. Insulet, which makes wearable insulin pumps, and CGM company Dexcom both grew revenues by at least 25% in the first quarter of 2021, bringing in $252 million and $505 million, respectively.
Insulet sizes up competition as Tandem, Medtronic plan new …
WEBPublished Feb. 29, 2024. Elise Reuter Reporter. Insulet plans to seek an indication for its Omnipod 5 patch-pump to be used by people with Type 2 diabetes. Courtesy of Insulet Corp. Insulet could face new competition as other insulin pump companies move into tubeless devices, but CEO Jim Hollingshead said he is not concerned in the short term ...
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