Medical Technology News | MedTech Dive
WEBBruker to acquire Nanostring for $393M. Bruker made an offer roughly two months after Nanostring filed for bankruptcy protection and said it may restructure. MedTech Dive provides medical technology news and analysis for industry professionals. We cover medical devices, diagnostics, digital health, FDA …
Intuitive details launch plan for new da Vinci 5 robot
WEBMar 18, 2024 · Intuitive Surgical will roll out the next generation of its market-leading da Vinci surgical robot in a limited launch that will extend into 2025, the company said Monday on a conference call with analysts. The phased launch, starting in the U.S., will allow Intuitive to gather feedback from surgeons, optimize the supply chain and expand ...
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 …
Medtronic starts US robotic surgery trial in push to challenge ...
WEBDec 20, 2022 · Dive Brief: Medtronic has enrolled the first patient in a U.S. clinical trial of its Hugo robotic-assisted surgery system, advancing its push to challenge Intuitive Surgical.; The clinical trial will enroll up to 122 patients at six sites in the U.S. to evaluate the use of Hugo in urologic procedures, a field in which Intuitive’s …
FDA starts review after study finds Boston Scientific's Watchman is ...
WEBSep 28, 2021 · An analysis published in JAMA Cardiology last month of a U.S. registry of almost 50,000 patients suggested Watchman is riskier for women than men. On multiple measures, women suffered more adverse events than men. The rate of adverse events in women was 6.3%, compared to 3.9% in men. The study found similar differences in the rates of major ...
Baxter considers selling kidney care unit to private equity
WEBMar 4, 2024 · Dive Brief: Baxter International is considering selling its kidney care business instead of spinning it out. The company disclosed in a U.S. Securities and Exchange Commission filing on Monday that it had been in recent discussions with private equity investors about a potential sale of the segment. Whether through a spinoff or sale, Baxter ...
Abbott secures FDA approval for dual-chamber leadless pacemaker
WEBJul 5, 2023 · Dive Brief: Abbott received approval from the Food and Drug Administration for a dual-chamber leadless pacemaker system that the company claims is the world’s first, Abbott announced Wednesday.; The system, called Aveir DR, consists of Abbott’s Aveir VR device, which paces the right ventricle and was approved in 2022, and its Aveir AR device, which paces the right atrium and was included ...
FDA panel backs vaginal mesh option, wants more data
WEBFeb 13, 2019 · The discussion came in light of data released by FDA last week showing that between January 2008 and October 2018, the agency found 10,391 Medical Device Reports citing serious injury, 806 citing device malfunction, and 77 citing death related to POP mesh products. However, those figures could be much lower than the actual scope of …
3 medtech spinoffs that reshaped the industry in 2023, and what …
WEBNov 29, 2023 · Johnson & Johnson spun off its consumer brands, including household names Tylenol, Listerine and Band-Aid, in May to form a new company called Kenvue. An initial public offering and a debt offering raised $13.2 billion in cash for J&J, while freeing the healthcare giant to focus on its larger pharmaceutical and medical device businesses.
Boston Scientific to pay $188.6M to settle mesh claims in 47 states
WEBMar 24, 2021 · Dive Brief: Boston Scientific will pay $188.6 million to 47 states and the District of Columbia to settle allegations that it deceptively marketed transvaginal surgical mesh devices to patients, the California Department of Justice announced Tuesday. The state's complaint alleges Boston Scientific misrepresented and failed to disclose the full extent of risks and complications associated with ...
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