FDA Clears AI Software Lunit INSIGHT MMG to Detect Breast Cancer
Lunit INSIGHT MMG is a deep learning based software that assists radiologists in analyzing mammograms.
Diagnostic Agents
FDA Approves Change in Contraindications for Optison
The removal of the contraindication to screen for hypersensitivity to blood and blood products is expected to improve workflow efficiency for health care professionals.
Risk of Falsely Low Results Prompts Recall of Lead Tests
The FDA is concerned that obtaining falsely low test results may lead to inappropriate follow-up assessments, which may result in patient harm.
FDA Clears Wearable, Wireless Thermometer for Prescription, OTC Use
The FDA has granted 510(k) clearance to Radius Tº, a wearable, wireless thermometer to measure body temperature for both prescription and over-the-counter use in individuals 5 years of age and older.
Lymphoseek Approval Expanded to Pediatric Patients
The approval was based on data from a phase 2 trial that assessed Lymphoseek in pediatric patients with melanoma, RMS, or other solid tumors.
FDA Advises Against Use of SARS-CoV-2 Antibody Tests to Assess Immunity After Vaccination
Results of qualitative, semi-quantitative, or quantitative SARS-CoV-2 antibody tests should not be interpreted as an indication of a specific level of immunity or protection from SARS-CoV-2 infection.
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