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The European Commission has released the first opinion by an expert panel assessing a product for compliance with the EU’s In Vitro Diagnostics Regulation (IVDR), which will go into effect on May 26, 2022. Read More
Invacare has received a warning letter from the FDA for — among other failures — not fully investigating an incident in which a patient who was using one of its oxygen concentrators had to be taken to the hospital in an ambulance because the device wasn’t producing enough oxygen. Read More
The test “has the potential to become the new first-step screening test” for people who choose not to participate in the existing screening programs for colorectal cancer, the company said. Read More
The company received a $10 million development contract from the Biomedical Advanced Research and Development Authority to develop the dressings. Read More
Outset Medical now plans to source the cartridges through a manufacturing partner in Mexico, which will avoid the expense of air freight from overseas and help mitigate future supply-chain risks, the company said. Read More
Several major manufacturers of tests for the SARS-CoV-2 virus that causes COVID-19 are saying their products will detect infections caused by the new Omicron variant first identified in South Africa and now spreading rapidly around the world. Read More
Sixty-one senators of both parties have sent a letter urging the Centers for Medicare & Medicaid Services (CMS) to find a way for Medicare to pay for breakthrough medical devices, after the agency withdrew a previous proposal to do so. Read More