Medical Technology News | MedTech Dive
WEBRoss Segan was chosen to lead the office, which handles premarket authorizations and recalls, in the agency’s Center for Devices and Radiological Health. 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.
MedTech Mergers & Acquisitions | MedTech Dive
WEBOct 2, 2024 · Integer sells non-medical business for $50M. After making nearly $550 million worth of acquisitions in the past few years, the medical device contract manufacturer will use proceeds from the sale to pay down debt. By Susan Kelly •Oct. 2, 2024. Mario Tama / Staff via Getty Images.
CMR Surgical secures $165M for its robot expansion
WEBSep 21, 2023 · CMR Surgical, a competitor to robotic surgery leader Intuitive Surgical, has raised $165 million in funding as it prepares to launch its Versius soft tissue system into more geographies. The influx will fund further commercialization of the system in existing markets as well, and will support continued product innovation, the company said ...
Medical Device News - MedTech Dive
WEB6 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.
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 ...
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 …
The top medtech trends in 2024
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.
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 ...
FDA reaches MDUFA V agreement with industry | MedTech Dive
WEBMar 9, 2022 · The FDA has “reached an agreement in principle” with industry on a framework for Medical Device User Fee Amendments (MDUFA) V, according to an agency statement emailed on Wednesday to MedTech Dive. While the FDA declined to share details of the MDUFA V agreement, an industry source with direct knowledge of the discussions told MedTech Dive ...
Ransomware attacks put availability of medical devices at risk: FDA ...
WEBOct 1, 2021 · Ransomware attacks on healthcare facility networks are causing medical device “outages” that put patient lives at risk, according to Kevin Fu, acting director of cybersecurity at the FDA’s Center for Devices and Radiological Health. “You can’t have a safe and effective medical device if it’s unavailable” due to ransomware, Fu told ...