Huma Therapeutics has been granted Class II clearance from the FDA for its Software-as-a-Medical-Device (SaMD) disease management platform, dramatically expanding the range of services it can deliver.

RAPS Digital Health/SaMD Collaborative Community on RegEx is to enhance engagement and knowledge sharing within this sector. This is a members-only community; any events, white papers, or research ...

CAMBRIDGE, Mass., April 08, 2026--(BUSINESS WIRE)--Anumana, Inc., a leader in cardiovascular AI, today announced U.S. Food and Drug Administration (FDA) clearance of its ECG-AI™ algorithm for cardiac ...

Otsuka and Click Therapeutics’ Rejoyn has become the first prescription digital therapeutic (DTx) to be approved by the FDA for people with major depressive disorder. Rejoyn (formerly CT-152), a ...

The discipline of classification and taxonomy involves the grouping of organisms into categories based on different properties including size, shape and gene sequences. Classification can help to ...

The convergence of (multi-)omics and artificial intelligence is transforming precision medicine by enabling data-driven diagnostics, treatment prediction, and patient stratification. Yet, regulatory ...

In order for the Council to be able to work in all areas which require the use of EU classified information (EUCI), it needs to have a comprehensive security system to protect this information. The ...

Betsy began her career in international finance and it has since grown into a comprehensive approach to journalism as she's been able to tap into that experience along with her time spent in academia ...

Fitzpatrick skin typing is a way of classifying skin types. Types range from 1 to 6, depending on skin features and the risk of sunburn and skin cancer. The sun’s UV rays increase the risk of skin ...