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WEBPolitan Capital Management said its candidates captured two board seats in Thursday’s shareholder vote, citing a preliminary analysis. MedTech Dive provides medical technology news and analysis for industry professionals. We cover medical devices, diagnostics, digital health, FDA regulation and compliance, imaging, and more.
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 conglomerate via a 2018 IPO, a suite of cancer treatment ...
Medical Device News - MedTech Dive
WEB3 days ago · Route 92 Medical raises $50M to fund global sales of stroke devices. The latest investment extends an earlier funding round, bringing the total raised to $82 million. Novo Holdings, the controlling shareholder of Novo Nordisk, joined returning investors. By Nick Paul Taylor • Sept. 24, 2024.
Medical device user fee update inches closer to approval
WEBApr 4, 2022 · FDA reaches MDUFA V agreement with industry. By Greg Slabodkin • March 9, 2022. Under the deal, the agency will receive $1.8 billion in user fees from 2023 to 2027. However, that could increase to $1.9 billion with add-on payments if the FDA’s performance goals are met, according to an industry source.
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 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 …
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.
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 ...
The FDA approved 2 renal denervation devices. There are still …
WEBDec 13, 2023 · Questions about efficacy . An FDA advisory panel in August recommended that the FDA approve Recor’s device but voted against approval of Medtronic’s device. For Recor’s Paradise system, panelists voted unanimously in favor of the device’s safety and 10-2 in favor of its risk-benefit profile, raising questions about the long-term durability of …
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 …