Seno Medical Gets Premarket Approval for Breast Cancer Diagnostic

Seno Medical has received premarket approval from the FDA for its Imagio Breast Imaging System that helps distinguish between benign and malignant breast lesions.

The opto-acoustic system uses light to produce sound waves for visualizing blood in biological tissue. The noninvasive ultrasound helps physicians to identify masses that may warrant a more invasive assessment.

The system generates a blood map in and around breast masses, as well as traditional anatomical images via ultrasound. And it includes an artificial intelligence-based support tool, SenoGram, that helps radiologists interpret the images.