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Eurofins said that the test can distinguish between vaccinated patients and patients who had an asymptomatic infection before or after inoculation. Read More
BD said the test can successfully detect the UK and South African coronavirus variants, providing a positive or negative result for both COVID-19 and the flu. Read More
SGS FIMKO Oy, a Helsinki-based subsidiary of the certification giant SGS, became the 18th notified body to be designated to provide product certifications under the European Medical Device Regulation (MDR). Read More
A strategy President Joe Biden outlined on the campaign trail to deal with U.S. supply chain vulnerabilities for critical products, including pandemic-related supplies, is likely to be put into effect via executive order within weeks. Read More
The U.S. has joined the World Health Organization (WHO)’s Access to COVID-19 Tools (ACT) Accelerator program, a global effort to speed development and production of coronavirus vaccines, treatments and diagnostic tests, and to help lower-income nations obtain them. Read More
The FDA’s Center for Devices and Radiological Health (CDRH) is getting ready to launch its Accreditation Scheme for Conformity Assessment (ASCA) pilot program allowing accredited testing laboratories to assess the conformance of a device with FDA-recognized standards. Read More
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) issued updated guidance that clarifies the deadlines for stand-alone software that must carry the UK conformity assessment mark (UKCA) for applications regulated as medical devices. Read More
The FDA has named Kevin Fu as acting director of medical device cybersecurity within the Center for Devices and Radiological Health (CDRH) — a newly created position in response to the agency’s growing concerns about cybersecurity threats. Read More
The single-arm study will span at least 50 sites in Europe, Asia and South America, and will involve patient follow-up at 30 days, six months, then every year for five years. Read More