Drugmaker Sarepta Therapeutics says it won't comply with a request from U.S. regulators to halt all shipments of its gene ...

Unlike expensive positron emission tomography (PET) scans or invasive lumbar punctures, the new blood test measures the ratio ...

The regulator authorized the company to keep its e-cigarettes on the U.S. market after a federal ban in 2022 had pushed it to ...

The initial sales of the next-generation Swoop® system-purchased by two top-tier hospitals in the northeastern United States-demonstrate a strong market response following FDA clearance and mark a ...

Genetic Leap, a clinical stage, AI-native biotech pioneering RNA genetic therapeutics, announced today that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) ...

The agency claims Whoop is marketing an unauthorized medical device intended to diagnose, cure, treat or prevent a disease.

The post This FDA-Cleared Device, Which Aims To Reduce Traumatic Brain Injury, Was Worn By Sauce Gardner During The 2024 NFL Season appeared first on AfroTech.

PathPresenter, a leading Image Management System and workflow platform for digital pathology, has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the PathPresenter Clinical ...

A polymer-based device cleared by the FDA offers physicians a new way for repairing peripheral nerve injuries.

The US FDA has cleared cell-cultivated seafood company Wildtype’s lab grown, cell-based salmon, marking a “first” for the sector.

The FDA has cleared other AI-powered tools for breast cancer detection, but Clairity marks the first platform that received a green light for predicting five-year risk from mammograms.

The Food and Drug Administration (FDA) cleared the first blood test recently to help diagnose Alzheimer's disease.