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.
The U.S. Food and Drug Administration today approved teclistamab in combination with daratumumab hyaluronidase-fihj, Tec-Dara, to treat adult patients with relapsed or refractory multiple myeloma who have received at least…
Read FDA announcementThe U.S. Food and Drug Administration today issued a Request for Information (RFI) seeking public comment on potential new standards for in-home opioid disposal products.
Read FDA announcementThe U.S. Food and Drug Administration today announced the issuance of 30 warning letters to telehealth companies for making false or misleading claims regarding compounded GLP-1 products offered on their…
Read FDA announcementThe U.S. Food and Drug Administration today issued an approval for the lung cancer drug Hernexeos (zongertinib) as a part of the new Commissioner's National Priority Voucher (CNPV) pilot program.
Read FDA announcementThe U.S. Food and Drug Administration today issued draft guidance for sponsors seeking approval for targeted individualized therapies by generating substantial evidence of effectiveness and safety when randomized controlled trials…
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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