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Bunkerhill Health Receives the US FDA’s 510(k) Clearance for Bunkerhill MAC to Detect and Quantify Mitral Annular Calcification

Shots:

  • The US FDA has granted 510(k) clearance to Bunkerhill MAC algorithm for the detection & quantification of mitral annular calcification (MAC)
  • Bunkerhill MAC, developed & tested using data from 25+ academic centers incl. Emory, Thomas Jefferson, & UCSF, automatically identify & quantify MAC on routine non-gated chest CTs using AI to standardize MAC detection & reporting
  • Bunkerhill MAC is available within the Carebricks platform, which analyzes structured & unstructured patient data to apply AI-driven reasoning across the full clinical context & automate next steps in care

Ref: Bunkerhill Health | Image: Bunkerhill Health| Press Release

Related News:- Hologic Secures the US FDA’s 510(k) Clearance & European CE Mark for Panther Fusion GI Bacterial Assays to Advance Gastroenteritis Diagnostics

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