AI medical device companies face major reimbursement hurdles when trying to secure coverage, CPT codes, and payment from ...
A novel comprehensive textbook on medical device clinical research, authored by Dr Ashish Indani, has been released, offering end-to-end guidance for professionals navigating the rapidly ...
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HeartBeam Stock Slumps After FDA Refuses Clearance For ECG Software
Roth Capital sees potential FDA clearance for the software. ・The FDA may want the company to use a different predicate device ...
Caranx Medical ("Caranx"), a French medical device company specializing in the development of an autonomous robot to democratize access to Transcatheter Aortic Valve Implantation (TAVI), a lifesaving ...
Learn why understanding the FDA’s 510(k) database is essential for every MedTech manufacturer. Discover how it supports competitive analysis, regulatory planning, faster approvals, and smarter product ...
Arizona wearable tech startups have landed $700,000 to advance medical monitoring devices as part of a cohort that has ...
US brain-computer-interface startup Paradromics is quickly establishing itself as a major player in the neural-device space, ...
Nandita Vijayasimha, Bengaluru Wednesday, November 19, 2025, 08:00 Hrs [IST] ...
Caranx Medical ("Caranx"), a French medical device company specializing in the development of an autonomous robot to democratize access to Transcatheter Aortic Valve Implantation (TAVI), a lifesaving ...
EDAP TMS SA (Nasdaq:EDAP) announced today that the FDA granted 510(k) clearance for new workflows for its ultrasound ...
The liability, safety, and accuracy questions underlying one creative proposal, in this week's AI Prognosis newsletter.
Health tech company Withings showcased BeamO, its “thermometer of the future," at CES 2024. As of Thursday, it's now ...
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