Has CDSCO Guidance Changed The Rules? Legal News and Analysis - India - Regulatory & Compliance - Conventus Law ...

Key Takeaways - FDA’s 2026 guidance clarifies when digital health tools fall outside device regulation. Updated policies for clinical decision ...

Generative artificial intelligence powered features such as chatting about what is in pictures, telling children bedtime stories, and imitating podcasters continue to ...

SOPHIA ANTIPOLIS, France--(BUSINESS WIRE)--Regulatory News: Median Technologies (FR0011049824, ALMDT, PEA/SME eligible, “Median” or “The Company”), a leading developer of eyonis™, a suite of ...

The court’s rationale Opposition against the IIa classification of telemedicine software Is telemedicine software a medical device at all? Impact on practice and the market Telemedicine is getting ...

Median Technologies (FR0011049824, ALMDT, PEA/SME eligible, “Median” or “The Company”), manufacturer of eyonis®, a suite of artificial intelligence (AI) powered Software as a Medical Device (SaMD) for ...

The FDA has entered into the federal register a new draft guidance pertaining to "software as a medical device" (SaMD). The guidance is presented as representing the FDA's current thinking on ...

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 ...

The FDA is contemplating changing its medical device for software approval process, JD Supra reports. Here’s what you should know. 1. Software as a medical device applies to all software used to ...

Fueled by convenience, fashion, size and technical innovation, medical devices have evolved from clinical settings to daily consumer use. Today’s highly personalized devices are being embedded into ...