The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...

PRNewswire/ - MolecuLight today announced that its MolecuLightDX(R) wound measurement has been qualified by the U.S. Food and Drug Administration (FDA) as a Medical Device Development Tool (MDDT). The ...

Rystiggo is administered weekly, 3ml to 6ml over 15 to 30 minutes for six weeks.

Over the past decade, FDA approvals of artificial intelligence and machine learning (AI/ML)–enabled medical devices have surged. They reached a record high of 221 last year, according to data tracing ...

For companies developing digital health products, wearables, or software-enabled devices, FDA’s latest guidance updates ...

FDA approves first brain stimulation device for home depression treatment. Flow Neuroscience's FL-100 headset uses electrical ...

The FDA has approved the first prescription, at-home neuromodulation therapy for individuals with major depressive disorder ...

Merit Medical Systems, Inc. announced that its WRAPSODY® Cell-Impermeable Endoprosthesis has received premarket approval from the FDA, allowing for commercialization in the U.S. starting in 2025. This ...

U.S. Food and Drug Administration approvals of life-changing, high-risk medical devices reportedly slowed to a 10-year low for the January to March period, as recent layoffs have reportedly had ...

A new $1.3 million report by the Institute of Medicine calls for a complete overhaul of the FDA’s 150(k) approval process for medical devices. “The 510(k) process cannot achieve its stated goals –– to ...

The majority of medical and surgical devices used to treat children are not cleared by the Food and Drug Administration for use in pediatric populations, according to a new report from the American ...