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.
GE HealthCare Debuts AI-Powered Cardiac CT Device at ACC Conference
April 1st 2025Featuring enhanced low-dose image quality with motion-free images, the Revolution Vibe CT system reportedly facilitates improved diagnostic clarity for patients with conditions ranging from in-stent restenosis to atrial fibrillation.
The Reading Room Podcast: Current Perspectives on the Updated Appropriate Use Criteria for Brain PET
March 18th 2025In a new podcast, Satoshi Minoshima, M.D., Ph.D., and James Williams, Ph.D., share their insights on the recently updated appropriate use criteria for amyloid PET and tau PET in patients with mild cognitive impairment.
