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NewStem Files FDA Pre-Submission and EMA IVDD for Revolutionary Life-Saving, Treatment-Changing Diagnostic Device

Bio-Platform NewStem Ltd announced the filing of a pre-submission to the FDA for a De Novo Request and an in vitro diagnostic device (IVDD)...

Israeli Startup Sanolla Receives FDA Clearance for the World’s First AI-Ready Infrasound Stethoscope

Israeli startup Sanolla, which provides AI-powered primary care diagnostic solutions, announced that the FDA has granted 510(k) clearance for the clinical use of the...

Kuleana Technology Receives the NKF Innovation Fund’s First Dialysis Investment

Kuleana Technology, Inc. (Kuleana), a Seattle Washington-based company, received the National Kidney Foundation (NKF) Innovation Fund's first dialysis investment. Kuleana is developing a groundbreaking...

Aviva Systems Biology Announces the Launch of High Throughput Antibody Characterization Services

Aviva Systems Biology, a market leader in antibodies, immunoassay kits, and recombinant proteins for life science research, announced the launch of its new service...

Aidoc Delivers the Most Comprehensive Neuroscience Package for AI-driven Coordination with New FDA 510(k) Clearance for Brain Aneurysm

Aidoc, the leading provider of healthcare AI solutions, announced that it received its 9th FDA 510(k) clearance for triage and notification of brain aneurysm....
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