TMCnet

Healium Announces FDA Registration of Healium Clinical as a Class II 510(k)-Exempt Biofeedback Medical Device

For clinicians navigating the growing demand for non-pharmacological tools, finding an engaging biofeedback and neurofeedback ...
Forbes

FDA Medical Device Cybersecurity And SBOMs: Compliance And Potential

When the Federal Drug Administration (FDA) updated the provisions for medical device cybersecurity, one of those required the development of a software bill of materials (SBOM). It’s now mandatory for ...

Food and Drug Administration (FDA): What It Is and Does

The Food and Drug Administration is a government agency that regulates certain food, drugs, cosmetics, and medical products.
MD&M East

FDA’s AI Device Regulations: Key Updates & Compliance Strategies for Medtech Success

FDA has moved artificial intelligence (AI) in medical devices from an exploratory concept to operational expectations, finalizing a pathway to pre-approved algorithm updates (PCCPs), publishing ...
JD Supra

CMS and FDA Propose Major Changes for Breakthrough Devices with Proposed Repeal of NTAP “Alternative Pathway” and New “RAPID” Coverage Pathway

The Centers for Medicare & Medicaid Services (CMS) and the Food and Drug Administration (FDA) recently issued two related proposals that, taken together, would significantly alter the pathways ...
Pharmabiz

Healium announces US FDA registration of Healium Clinical as a Class II 510(k)-exempt biofeedback medical device

Healium, a non-pharmacological digital health company, announced the US FDA registration of Healium Clinical as a Class II 510(k)-exempt biofeedback medical device. The US FDA registration accelerates ...