The FDA has released a proposed rule to clarify the kind of evidence it will consider relevant when determining the intended uses of a medical product. Among the types of evidence the agency considers relevant include implied claims, express claims and representations, product designs and characteristics, and the circumstances of distribution or sale.

The FDA has given emergency use authorization to Vela Diagnostics for its automated ViroKey SARS-CoV-2 RT-PCR Test v2.0. A manual version of the test received an EUA in August.

A premarket approval supplement application has been submitted by Becton Dickinson to the FDA to allow use of the company's ThinPrep Pap Test PreservCyt Solution vial with its BD Onclarity HPV Assay.

Rick Simmons has been chosen to serve as chief marketing officer of Spinal Elements, starting Aug. 3. Simmons has previously worked for DePuy Synthes.

Research published in JAMA Network Open shows that a routine blood test for red cell distribution width could be used as a potential indicator of a COVID-19 patient's risk for severe illness and death. Patients who had levels above the normal range were nearly three times as likely to die from the disease.

The WaveForm C Interbody Implant System, a 3D-printed interbody device, has been released by SeaSpine on a limited basis.

The FDA has given 510(k) clearance to Surmodics for its Pounce Thrombus Retrieval System that is used to remove emboli and thrombi from the peripheral arterial vasculature.

The FDA has given 510(k) clearance to RTI Surgical for its Dynamic Active Compression Plate that provides fixation and stabilization for small bones in the foot.

The FDA has given 510(k) clearance to NOUS Imaging for its Framewise Integrated Real-Time MRI Monitoring software that calculates patient motion during MRI head scans.

President Donald Trump said he's looking at reports that the FDA plans to implement stricter emergency use authorization standards for potential COVID-19 vaccines, noting the administration "may or may not approve" the changes.