The main market opportunities lie in leveraging AI, ML, and LLMs to enhance efficiency and effectiveness in FDA-regulated medical device and SaMD development. These technologies can drive innovation, ...

The risks of using unauthorized BP devices, the FDA said, include failure to detect changes in BP, delays in seeking ...

Many of these devices currently sold over-the-counter do not have marketing authorization, the agency said in a notice.

The main market opportunities lie in adapting FDA-regulated computer system validation methods to align with GAMP®5 Second Edition and CSA, embracing innovative technologies like AI, ML, and ...

The FDA draft guidance "Considerations for Complying with 21 CFR 211.110" raises points to consider regarding drug products ...

With the rise of robotic and minimally invasive surgery and other innovations, medicine has moved into the 21st century.

Dublin, Sept. 10, 2025 (GLOBE NEWSWIRE) -- The "Computer System Validation (CSV) Training Course (Sept 23rd - Sept 25th, 2025)" training has been added to ResearchAndMarkets.com's offering. The ...

Health care leaders may want to keep a closer eye on clinical validation for artificial intelligence (AI)-enabled medical devices (AIMDs), based on a recent JAMA Health Forum study.

FDA registration fulfills requirements for U.S. market entryInitial shipments to Europe and Latin America to begin with pre-approved countriesYONGIN, South Korea, Sept. 23, 2025 /PRNewswire/ -- Noul ...

Ahead of watchOS 26 being released today, Apple has enabled the new Hypertension Notifications feature on compatible Apple ...

AccurKardia, an innovator in ECG-based diagnostics technology, has announced the initiation of a multicenter clinical pilot of AK+ GuardTM, an FDA Breakthrough Device Designated AI-powered technology ...

Medera is a clinical-stage biopharmaceutical company focused on targeting difficult-to-treat and currently incurable diseases by developing a range of next-generation therapeutics. Medera operates via ...