Digirad applies for FDA clearance
Digital gamma camera developer Digirad of San Diego hasfiled forregulatory clearance with the Food and Drug Administration forits lead product, Notebook Imager. If and when the applicationis cleared, Notebook Imager will become the first solid-stategamma
Digital gamma camera developer Digirad of San Diego hasfiled forregulatory clearance with the Food and Drug Administration forits lead product, Notebook Imager. If and when the applicationis cleared, Notebook Imager will become the first solid-stategamma camera to be marketed commercially.
Notebook Imager is a portable gamma camera that uses a cadmiumzinc telluride detector array rather than scintillation crystalsand photomultiplier tubes, as conventional Anger-style camerasdo (SCAN 6/5/96). Digirad hopes to receive FDA clearance and beginmarketing the system next year.
To help ramp up its manufacturing and product-testing effort,Digirad completed a $6 million financing issued to a group ofventure-capital firms. Proceeds from the funding will be usedto finish beta-site testing and develop a manufacturing capacityfor Notebook Imager. The funding was led by Sorrento Ventures,and included Kingsbury Capital Partners and several individualinvestors.
Considering Breast- and Lesion-Level Assessments with Mammography AI: What New Research Reveals
June 27th 2025While there was a decline of AUC for mammography AI software from breast-level assessments to lesion-level evaluation, the authors of a new study, involving 1,200 women, found that AI offered over a seven percent higher AUC for lesion-level interpretation in comparison to unassisted expert readers.
