The rise of AI in health care presents new challenges related to the patentability and regulation of AI-driven medical technologies. This article examines the 2024 guidelines from the U.S. Patent and ...

With an initial indication for type 2 diabetes, SaMD developer UpDoc says its platform is designed to support doctors, not ...

The Asian Harmonization Working Party (AHWP), a regulatory group focused on the harmonization of regulations across Asia and various other emerging economies, has released for comment a new white ...

Software-based medical devices are integral to healthcare. To enter the marketplace, a company must successfully navigate and comply with applicable national and international regulatory requirements.

eyonis® LCS commercial launch is ongoing in U.S. following FDA 510(k) clearance CE-marking regulatory process is on-going with a decision expected in Q2 2026 that could trigger commercial rollout of ...

Artificial intelligence (AI) is no longer the future of healthcare—it’s already here. AI-driven medical devices are diagnosing diseases faster than doctors, guiding surgical procedures with precision ...

As FDA medical device lawyers advising AI and digital health companies, Hogan Lovells lawyers have had a front-row seat to an increasingly common scenario: software platforms and mobile apps that ...

SOPHIA-ANTIPOLIS, France--(BUSINESS WIRE)--Regulatory News: Median Technologies (FR0011049824, ALMDT, “Median” or the “Company”), developer of eyonis®, a suite of artificial intelligence (AI)-powered ...

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 ...

Median Technologies (FR0011049824, ALMDT, “Median” or the “Company”), developer of eyonis®, a suite of artificial intelligence (AI)-powered Software as a Medical Device (SaMD) solutions for early ...