Key Takeaways - FDA’s 2026 guidance clarifies when digital health tools fall outside device regulation. Updated policies for clinical decision ...
PRNewswire/ - MolecuLight today announced that its MolecuLightDX(R) wound measurement has been qualified by the U.S. Food and Drug Administration (FDA) as a Medical Device Development Tool (MDDT). The ...
India-US trade deal: Domestic industry seek reciprocity as India agrees to ease entry for US devices
India agrees to ease non-tariff barriers for US medical devices, but domestic industries seek reciprocity to ensure balanced ...
GlobalData on MSN
FDA grants clearance for Eyas Medical Imaging’s neonatal MRI system
Eyas Medical Imaging is currently scaling up operations with plans to commercialise the system in the US later this year.
Regulated healthcare companies are under increasing pressure to move faster while maintaining the highest standards of ...
The FDA's approval process was designed for medical devices that stay largely the same after launch. Clinical AI does not ...
10d
Enlil and Interlynk Partner to Close the Cybersecurity Gap for SaMD and Connected Medical Devices
The integrated solution delivers a shift-left approach to cybersecurity, enabling executive teams to proactively embed security, quality, and compliance from early development to post-market. When ...
Experts say two new guidances — issued without the usual public comment period — leave questions about how patients will ...
On January 6, 2026, the FDA issued a Guidance for Industry and Food and Drug Administration Staff regarding Clinical Decision Support (CDS) ...
Enlil and Interlynk join forces to transform SBOMs into dynamic tools for managing cybersecurity in medical devices.
Outset Medical announced today that it received FDA 510(k) clearance for its next-generation Tablo hemodialysis platform.
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