We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The FDA issued final guidance for bioburden reduction systems that use dry heat to help support single-user reuse of certain particulate filtering facepiece respirators (FFRs) as the need for FFRs may outpace the supply available to healthcare organizations during the COVID-19 pandemic. Read More
Australia’s Therapeutic Goods Administration (TGA) released new regulatory requirements for personalized medical devices that will go into effect on Feb. 25, 2021. Read More
The European Commission’s Medical Device Coordination Group has released long-awaited guidance on how to classify products for compliance with the European Union’s In Vitro Diagnostic Regulation (EU IVDR). Read More
When asking for a meeting, sponsors should include product information, such as a description of the product and its constituent parts, the agency said. Read More
BAROSTIM received premarket approval from the FDA in 2019 for reducing symptoms associated with heart failure in patients who suffer from a left ventricular ejection fraction of 35 percent or less. Read More
The guidance says the annual survey ideally should be completed as soon as possible, occurring within six months of the 14-month date from the prior completed survey. Read More
The company last month unveiled Biocare Telemed, a “virtual clinic” that provides patients access to medical care and remote cardiac monitoring. Read More