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.
Emerging AI Algorithm Shows Promise for Abbreviated Breast MRI in Multicenter Study
April 25th 2025An artificial intelligence algorithm for dynamic contrast-enhanced breast MRI offered a 93.9 percent AUC for breast cancer detection, and a 92.3 percent sensitivity in BI-RADS 3 cases, according to new research presented at the Society for Breast Imaging (SBI) conference.
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.
Can Abbreviated Breast MRI Have an Impact in Assessing Post-Neoadjuvant Chemotherapy Response?
April 24th 2025New research presented at the Society for Breast Imaging (SBI) conference suggests that abbreviated MRI is comparable to full MRI in assessing pathologic complete response to neoadjuvant chemotherapy for breast cancer.
Clarius Mobile Health Unveils Anterior Knee Feature for Handheld Ultrasound
April 23rd 2025The T-Mode Anterior Knee feature reportedly offers a combination of automated segmentation and real-time conversion of grayscale ultrasound images into color-coded visuals that bolster understanding for novice ultrasound users.
