Biofield submits PMA for breast device
The Food and Drug Administration has agreed to provide expeditedreview of an Atlanta start-up company's premarket approval (PMA)application for a device designed to identify malignant breastlesions without surgical biopsy. Biofield's Alexa 1000
The Food and Drug Administration has agreed to provide expeditedreview of an Atlanta start-up company's premarket approval (PMA)application for a device designed to identify malignant breastlesions without surgical biopsy. Biofield's Alexa 1000 devicecould compete with technologies such as ultrasound in providingnoninvasive breast lesion characterization without the use ofx-rays.
Alexa 1000 employs single-use sensors and a measurement deviceto detect and analyze changes in cellular electrical charge distributionsassociated with the development of epithelial cancers, such asbreast cancer. A multicenter clinical study of over 1000 womenin the U.S. found that the system was about 95% accurate in identifyingmalignant breast lesions.
Biofield's stock leaped 59% to $14.12 a share on the news thatAlexa 1000's PMA was accepted by the FDA, and was trading at about$14.75 this week.
Study Shows No Impact of Hormone Therapy on PET/CT with 18F-Piflufolastat in PCa Imaging
May 7th 2025For patients with recurrent or metastatic prostate cancer, new research findings showed no significant difference in the sensitivity of 18F-piflufolastat PET/CT between patients on concurrent hormone therapy and those without hormone therapy.
