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Pfizer has completed its acquisition of Australian diagnostic software developer ResApp Health for $115 million, expanding its reach into digital health products. Read More
Natera’s Signatera circulating tumor DNA (ctDNA) test outperformed the cancer antigen CA 125 test by one month and radiological imaging by 10 months in identifying patients with the highest risk of recurrence of epithelial ovarian cancer (EOC), researchers reported in the journal Gynecologic Oncology. Read More
Flawless Beauty and Skin is importing and marketing unapproved devices, according to a warning letter the FDA sent the Ocean, N.J., firm following an inspection at that facility Nov. 16, 2021, through Jan. 19, 2022. Read More
Most machine learning-enabled medical devices are cleared by the FDA without efficacy demonstrated in a randomized clinical trial, researchers at the Harvard-MIT Health Sciences and Technology program reported in the journal JAMA Network Open. Read More