New FDA Draft Guidance Sets Bar for Cuffless Blood Pressure Devices – Clinical Performance Now in Focus
The FDA has released a draft guidance outlining new clinical performance requirements for cuffless non-invasive blood pressure devices. Manufacturers using wearable sensors or AI must now meet specific testing standards, including ISO 81060-2. Learn how these updates affect premarket submissions and regulatory strategies.
NIST Releases Draft Cybersecurity Profile for AI: What It Means for Medical Device Manufacturers
NIST has released its Cybersecurity Framework Profile for AI (Draft, Dec 2025). Learn what this means for medical device manufacturers using AI or ML in their devices.