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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.
FDA Approves Fluorescence Imaging System for Detecting Residual Breast Cancer
April 18th 2024The combination of the optical imaging agent Lumisight and the fluorescence imaging device Lumicell Direct Visualization System, collectively known as LumiSystem, reportedly offers 84 percent accuracy with real-time detection of residual breast cancer after lumpectomy procedures.
Study of Ofatumumab for Multiple Sclerosis Shows 'Profoundly Suppressed MRI Lesion Activity'
April 17th 2024The use of continuous ofatumumab in patients within three years of a relapsing multiple sclerosis diagnosis led to substantial reductions in associated lesions on brain MRI scans, according to research recently presented at the American Academy of Neurology (AAN) conference.
Could a Deep Learning Model for Mammography Improve Prediction of DCIS and Invasive Breast Cancer?
April 15th 2024Artificial intelligence (AI) assessment of mammography images may significantly enhance the prediction of invasive breast cancer and ductal carcinoma in situ (DCIS) in women with breast cancer, according to new research presented at the Society for Breast Imaging (SBI) conference.
