Device software is a growth engine for digital transformation. Discover strategies to implement consumption models and prove ...

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.

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 ...

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 ...

Draft guidelines aim to align India's medtech software framework with global practices; industry seeks more clarity on AI/ML ...

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 ...

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 ...

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 ...