DeepHealth Receives Two FDA Clearances for AI-Powered Breast Suite

Product / TechRegulation
โดย GlobeNewswire·Read original
Summary · why it matters

DeepHealth has received FDA 510(k) clearances for two new functionalities in its AI-powered Breast Suite. The first is a Breast Arterial Calcification Assessment tool that automatically identifies breast arterial calcifications on standard screening mammograms, a potential early indicator of cardiovascular disease, with over 90% sensitivity and over 88% specificity in clinical testing. The second is prior exam integration into ProFound Pro, now marketed as Mammo Dx, which automatically processes prior and current studies to track lesions and distinguish new ones, aiming to improve cancer detection rates and reduce recalls. Both additions are now commercially available in the United States and will be deployed across RadNet imaging centers.

Impact on stocks 2

Artificial Intelligence · 1 stocks
RadNet Inc
RDNT
▲ PositiveTechnologyrelevance

RadNet will deploy the newly FDA-cleared AI tools across its imaging centers, enhancing its service offering.

Financials · 1 stocks

Theme Impact 2

Off-coverage companies 1

DeepHealth, Inc.Private▲ Positive
Regulationrelevance

DeepHealth received two FDA 510(k) clearances for its AI-powered Breast Suite, enabling commercial availability.

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