U.S. Software as a Medical Device Market to Reach USD 715 Million by 2033 as AI-Driven Diagnostics and Digital Therapeutics Accelerate Adoption

According to DataM Intelligence, the U.S. Software as a Medical Device (SaMD) Market Size reached USD 205.12 million in 2024 and is forecast to climb to USD 715.00 million by 2033, expanding at a ...
JD Supra

Software As A Medical Device In Europe – New Regulatory Regime About To Enter Into Force – (Part 2 Of 6)

As is already the case under the current EU Medical Device Directive 93/42/EEC (as amended by Directive 2007/47/EC – “MDD”), the purpose for which the software is intended to be used is and remains ...
The Financial Express

New regulations on the anvil for medical device software

The Central Drugs Standard Control Organisation (CDSCO) has issued a draft guidance document on medical device software to bring more clarity on the regulatory aspects of their usage. The document, ...
The Sociable on MSN

ProVoyance, intive partner-up to advance AI-powered orthopedic devices

The convergence of AI, specialized software, and clinical expertise is creating a new paradigm in orthopedic patient car ...
Medical Device Network on MSNOpinion

UK reforms highlight the case for digital submissions in medical device regulation

Diogo Geraldes, director of regulatory strategy, Europe at Veeva MedTech, discusses the potential of digital submissions to ...
Business Wire

Median Technologies to share positive pivotal data for eyonis™ LCS diagnostic software as medical device at the IASLC 2024 World Conference on Lung Cancer

SOPHIA ANTIPOLIS, France--(BUSINESS WIRE)--Regulatory News: Median Technologies (FR0011049824, ALMDT, PEA/SME eligible, “Median” or “The Company”) announces today that the Company will be sharing ...
Business Wire

Median Technologies to Showcase Its Artificial Intelligence Software as a Medical Device for Lung Cancer Screening, eyonis™ LCS, at the European Congress of Radiology

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 ...
JD Supra

Software As A Medical Device In Europe – New Regulatory Regime About To Enter Into Force – (Part 3 Of 6)

Already under the current MDD regime, medical devices, such as stand-alone MDSW, are classified according to their intended purpose and their inherent risks, and are divided into the following four ...