Browsing: medical devices

The European Commission has adopted an implementing regulation for joint scientific consultations on medical devices and in vitro diagnostic medical devices under the Health Technology Assessment (HTA) Regulation.

Nexalin Technology expresses strong support for the Health Tech Investment Act, a bipartisan legislation aimed at expanding Medicare reimbursement for AI-enabled medical devices

Dr. Scott Schell of Cognizant discusses the implications of the FDA’s draft guidance on AI-enabled medical devices, highlighting the agency’s increasing regulatory focus on this technology.

A summary of the 2025 Medical Device Recall Index Report, focusing on recall statistics, regulatory updates, and legal developments.

AdvaMed outlines key principles to promote broader access to digital health technologies, including AI/ML, and FDA-regulated innovations.

SINTX Technologies, Inc. announced the sale of its subsidiary, Technology Assessment and Transfer (TA&T), to focus on the medical device sector, improve its financial position, and streamline operations.

Researchers launch 4D Health Tech project to create medical devices that adapt to human growth and change, potentially revolutionizing patient care and reducing healthcare costs.

Expert advice on designing transparent and effective clinical trials for medtech startups.

A new study shows that a sensor-loaded T-shirt can help track patients’ vital signs after urological surgery, potentially allowing for earlier hospital discharge and detecting health problems.

Bruin Biometrics was named one of Fast Company’s Most Innovative Companies for their Provizio® SEM Scanner, which facilitates early detection of pressure injuries, regardless of a patient’s skin color.