Healthcare
DeepHealth Receives Two FDA Clearances Enabling it to Add Cardiovascular Insights and Prior Exam Integration to its AI-Powered Breast Suite
New capabilities are designed to improve cancer detection and recall rates and enable physicians to make informed cardiovascular decisionsSOMERVILLE, Mass., June 25, 2026 (GLOBE NEWSWIRE) -- DeepHealth, Inc., a leader in AI-powered health informatics and a wholly owned subsidiary of RadNet, Inc. (NASDAQ: RDNT), announces it has received FDA 510(k) clearances for two new Breast Suite1 functionalities: Breast Arterial Calcification (BAC) Assessment, a tool applied to standard screening mammograms
About this update from Radnet, Inc.
New capabilities are designed to improve cancer detection and recall rates and enable physicians to make informed cardiovascular decisions SOMERVILLE, Mass., June 25, 2026 (GLOBE NEWSWIRE) -- DeepHealth, Inc., a leader in AI-powered health informatics and a wholly owned subsidiary of RadNet, Inc. (NASDAQ: RDNT), announces it has received FDA 510(k) clearances for two new Breast Suite1 functionalities: The two additions reinforce Breast Suite as the industry's most comprehensive end-to-end breast imaging AI suite—a modular, interoperable portfolio of applications addressing real-world clinical needs across breast cancer screening and diagnostic pathways. Both newly FDA cleared functionalities are now commercially available in the United States. "Our strategy has always centered around using AI to find disease early. BAC Assessment and Mammo Dx are proof points of that strategy: one adds a cardiovascular evaluation to a routine breast cancer screening mammogram and the other incorporates changes from past mammogram exams into current mammograms to improve cancer detection. Together, they transform Breast Suite into a fully integrated suite of solutions that give radiologists a more complete patient overview and added clinical confidence in two of the top causes of death in U.S. women," said Niccolo Stefani, MD, Business and Product Leader, Population Health & Clinical AI, DeepHealth. BAC Assessment analyzes standard 2D (FFDM) and 3D (DBT) mammograms, automatically identifying and flagging breast arterial calcifications within the radiology workflow with no additional imaging required beyond the mammogram. BACs visible on mammograms have been linked to an elevated risk of future cardiovascular events, including heart attacks and strokes.2 In clinical performance testing, DeepHealth's BAC Assessment demonstrated more than 90% sensitivity and more than 88% specificity in identifying arterial calcifications across both dense and non-dense breast tissue.4 BAC Assessment is now commercially available and will be deployed across RadNet imaging centers in the U.S., providing additional real-world validation of its capability.