Breaking news, FDA approvals, clinical studies, and innovations in medical device technology
Baird Medical launches in Egypt with the first bone ablation procedure using MWA system at Ain Shams Hospital.
FDA issued an approval for Bizengri (zenocutuzumab-zbco), a drug that treats NRG1 fusion-positive cholangiocarcinoma, an ultra-rare, aggressive cancer that forms in the bile ducts.
Read FDA announcementThe U.S. Food and Drug Administration today issued a final guidance for industry, Postapproval Pregnancy Safety Studies, with recommendations on different methodologies that can be used in the postapproval setting…
Read FDA announcementFDA announced major steps in its bold initiative to modernize the agency. The agency launched Elsa 4.0, a significant upgrade to the agency’s internal AI tool available to all FDA…
Read FDA announcementFDA announced that it is piloting one-day inspectional assessments, as part of a broader initiative to make its inspectional resources more targeted and efficient.
Read FDA announcementFDA today authorized the marketing of four Glas electronic nicotine delivery systems (ENDS) through the premarket tobacco product application (PMTA) pathway.
Read FDA announcementMore than 30 organizations, including AdvaMed and the American Clinical Laboratory Association, are pushing for a permanent legislative solution to stop looming Medicare payment cuts for diagnostic tests.
This week in Pedersen's POV, our senior editor ponders a tough question about an emerging industry trend that could leave important technologies in the dust.
Making tomorrow’s breakthroughs a reality for the patients who need.
Discover three strategies for MedTech companies to design streamlined, effective trials and how quality data powers smarter study design.
The update is intended to cut the risk of endobronchial combustion that has been linked to serious injuries and one death.
Medline Industries has disclosed its executive pay packages in the registration statement filed with the SEC ahead of the medical device manufacturer’s proposed initial public offering. Unlike publicly traded companies,…
By Brian Fink, Product Manager, Aerotech Optimizing motion systems to transform cylindrical tube stock into life-saving medical devices can be challenging, especially when the process needs to be both fast…
Ullem, who has held the position for more than a decade, will transition to an advisory role after his replacement is named by mid-2026.
A new study finds that publicly traded companies' AI medical devices face more recalls and less clinical testing before market approval.
The appointment fills a position made available when Bob McMahon resigned as CFO on July 31.
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