FDA Related News

Human Drugs

Naviswiss Hip Replacement Navigator Cleared

FDA clears a Naviswiss 510(k) for its Naviplan, a digital pre-operative planning application to assist orthopedic surgeons in performing navigated tot...

FDA OKs Resumption of Inovio Covid Vaccine Trial

FDA authorizes Inovio to proceed with the Phase 3 INNOVATE segment of its investigative DNA Covid vaccine clinical trial.

Human Drugs

FDA Clinical Hold on Pfizer Hemophilia A Trial

FDA places a clinical hold on a Pfizer Phase 3 trial of a gene therapy candidate to treat hemophilia A.

Medical Devices

Ellume Covid Test Recall is Class 1: FDA

FDA says the Ellume recall of certain lots of its Covid-19 home test due to an unacceptable level of false-positive results is Class 1.

Medical Devices

HeartVista MRI Software Cleared for Siemens Scanner

FDA clears a HeartVista 510(k) to provide its artificial intelligence-assisted One Click MRI acquisition software on Siemens Healthineers MRI scanners...

Medical Devices

Aligned Medical Solutions Recalls Convenience Kits

Aligned Medical Solutions recalls its custom convenience kits due to the potential for the plunger on the Cardinal Health Monoject Flush Prefilled Syr...

Medical Devices

Meridian Bio EUA for Covid Assay

FDA grants Meridian Bioscience an emergency use authorization for its Revogene SARS-CoV-2 assay, a molecular diagnostic test for the qualitative detec...

Human Drugs

Kalo Paying $12.7 Million to End False Claims Case

The Justice Department says kalo is paying $12.7 million to resolve a whistleblowers allegations that it induced false claims for its Evzio anti-opioi...

Human Drugs

Vektor Medical 510(k) for ECG Mapping Tool

FDA clears a Vektor Medical 510(k) for vMAP, a computational electrocardiogram mapping system for use to improve outcomes in ablation procedures.

Biologics

CHD Wants Probe of FDA Actions on Pfizer Vaccine

Childrens Health Defense calls for a congressional probe of FDAs handling of a whistleblowers complaint about poor research practices at a contractor ...