Study reveals a gap FDA approval AI radiology devices with only 29% undergoing clinical testing before clearance.
Beyond Tariffs: The Software Supply Chain Risks Every Medical Device Manufacturer Should Be Watching
By reframing security as an investment rather than a cost, MDMs can reduce risk exposure, improve compliance readiness, and ...
FDA Section 524B transformed medical device cybersecurity from guidance to law, challenging small medtech firms with ...
The FDA is requiring stronger warnings for tranexamic acid (TXA) injection to avoid medication errors following reports of serious injury, including death. "FDA is ...
The "FDA Regulatory Compliance for Drug and Biotech Products (Nov 12th - Nov 13th, 2025)" training has been added to ResearchAndMarkets.com's offering. Regulatory Compliance is the level of activity ...
The cervical disc replacement landscape just got a major upgrade. The FDA has officially granted premarket approval (PMA) for two-level indications for not one, but two total disc replacement (TDR) ...
THE WHAT? The U.S. Food and Drug Administration (FDA) has issued a Safety Communication regarding the use of radiofrequency (RF) microneedling devices, citing reports of serious complications ...
Rhythio Medical’s soft, conductive hydrogel technology transforms traditional defibrillation into a new class of injectable bioelectronic therapy Rhythio Medical, a medical device company pioneering ...
Instagram is introducing parental controls and limits to conversations on topics like self-harm as concerns grow over how A.I. chatbots affect mental health. By Eli Tan Eli Tan reports on Meta and ...
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