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 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.

The Lumipulse test has specifically been approved to help diagnose the disease in the clinical setting. Dr. Amanada Smith said that makes it the first and only test with that advantage.

Tired of allergy symptoms getting you down? This FDA-cleared allergy relief device from SoundHealth combats nasal congestion — details ...

Pearl, the global leader in dental AI solutions, today announced that it has received FDA 510(k) clearance for Second Opinion® 3D, making Pearl the first and ...

The company’s original Second Opinion® platform remains the most widely deployed FDA-cleared solution for chairside AI pathology detection in 2D radiographs.