Navigating the SaMD regulatory pathways is one of the most complex yet important aspects of product development for medical technology startups. Startups in this field are required to meet local ...

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 ...

As AI and machine learning have become more important for the betterment of healthcare, the introduction of software as a medical device (SaMD) tools has shown promising results for doctors and ...

Median Technologies (FR0011049824, ALMDT, PEA-PME scheme eligible, "Median" or the "Company"), manufacturer of eyonis®, a suite of artificial intelligence (AI) powered Software as a Medical Device ...

This morning, the FDA published its 17-page first draft of a working model for its pre-certification program for software as a medical device (SaMD). Though still preliminary (the agency is asking for ...

Software as a Medical Device (SaMD) is finding its way into more and more patients’ hands through its ability to piggyback off the computing power of the ordinary and ubiquitous smartphone. SaMD can ...

The FDA’s Center for Devices and Radiological Health has withdrawn its December 2017 final guidance for clinical evaluation ...

Artificial intelligence (AI) is transforming the health care landscape, from diagnostics to drug development and clinical trials. As AI technologies rapidly evolve, global regulators face the complex ...

CRYSTAL LAKE, Ill.--(BUSINESS WIRE)--Aptar Digital Health, a global leader in digital health solutions (Software as a Medical Device (SaMD) and digital Patient Support Programs), connected devices and ...

The MarketWatch News Department was not involved in the creation of this content. Backed by strategic investor Laboratorios Sanfer, partly owned by General Atlantic and CDPQ, Medsi AI is addressing ...