HoneyNaps received US FDA 510(k) clearance, designated K253390, for SOMNUM V3.0, validating AI-based classification of ...

A distributed “hub-and-spoke” operation could register as one establishment, reducing administrative friction while improving ...

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. This week, ...

Recently, ACROBiosystems has officially received the 'Material Suitability Confirmation for Regenerative Medicine Products' (Certificate No.: 薬機審長発第47号) from the Pharmaceuticals and Medical Devices ...

While AI shows promise in healthcare, the way some AI tools are tested and approved doesn't generate much confidence.

A Missouri woman has filed a federal lawsuit alleging that a Nevro spinal cord stimulation device implanted to treat chronic ...

A clinical-stage immunotherapy designed to tackle one of the world’s most common age-related conditions has received a ...

This article explores how new approach methodologies are transforming drug discovery through human-relevant models, including ...

Cara Delevingne opens up about addiction, sobriety and why she believes smartphones and social media can be as addictive as drugs.

New collaboration embeds Canary Speech's vocal biomarker technology into NeuroLexIQ's Concussion Probability Report, flagging potential brain injuries at a client's very first contact PROVO, Utah and ...

We’re at the early stages of having doctors understanding how to utilize these tests and how to move forward.” ...