Archive for June 2021
Latest iCad 3D Mammography AI Gains CE Mark
iCAD, Inc., a global medical technology leader providing innovative cancer detection and therapy solutions, today announced that ProFound AI® Version 3.0 for Digital Breast Tomosynthesis (DBT) received CE Mark approval. Compared to previous software versions, the latest generation of ProFound AI offers up to a 10% improvement in specificity performance while maintaining an industry-leading high sensitivity…
Read MoreSpino Modulation Vertebral Body Tethering Device Wins FDA Breakthrough Device Designation
Spino Modulation Inc., a subsidiary of Spinologics Inc., announced today that the U.S. Food and Drug Administration (FDA) has granted the company a Breakthrough Device Designation for its MIScoli™ system, an innovative vertebral body tethering (VBT) device to treat scoliosis in young adolescents. The FDA Breakthrough Device Program is intended to help patients receive more timely…
Read MoreCognoa Receives FDA Marketing Authorization for First-of-its-kind Autism Diagnosis Aid
Cognoa, a pediatric behavioral health company developing diagnostic and therapeutic solutions for children living with behavioral health conditions, today announced that the U.S. Food and Drug Administration (FDA) has granted the company’s De Novo classification request for its autism diagnosis aid. The AI-based device is the first FDA-authorized diagnosis aid designed to help physicians to…
Read MoreAliveCor Purchases CardioLabs
AliveCor, the global leader in FDA-cleared personal electrocardiogram (ECG) technology and services, today announced that it has acquired the independent diagnostic testing facility (IDTF) CardioLabs, a leading monitoring and cardiac diagnostic service provider. The acquisition is a cornerstone of AliveCor’s mission to extend its comprehensive cardiological services to patients who are prescribed monitoring devices by…
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