News and Notes

Today, the U.S. Food and Drug Administration (FDA) issued an immediately in effect guidance that allows manufacturers of certain FDA-cleared or FDA-approved extracorporeal membrane oxygenation (ECMO) and cardiopulmonary bypass devices to expand device indications or...

The American College of Surgeons (ACS) recognizes that many health care facilities are facing shortages of personal protective equipment (PPE), including face masks, gowns, and respirators. The ACS believes it is essential that surgeons, nurses, anesthesiologists, and...

Getinge, a market leader in advanced ventilators for intensive care units, is announcing yet another ramp-up in production capacity, to 26,000 ventilators in 2020. The increase equals a growth of 160% compared to 2019, when 10,000 ventilators were produced. The demand...

Today, the U.S. Food and Drug Administration (FDA) issued an immediately in effect guidance, Enforcement Policy for Infusion Pumps and Accessories During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency, that provides regulatory flexibility for...

Dilon Technologies® Inc., a world class global leader in breast cancer treatment and diagnosis and owner of the Navigator Gamma Probes has acquired substantially all the assets of Dune Medical, including Dune Medical’s “MarginProbe”. “With the...

The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic: FDA-ARGOS SARS-CoV-2 Reference Grade Sequence Data Now Available: In response to the COVID-19 pandemic, the FDA—in collaboration...