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November 25, 2020
European Commission Clarifies In Vitro Diagnostic Classification Rules
The new regulation goes into effect on May 26, 2022, except for in vitro diagnostics that qualify for a grace implementation period that extends to May 27, 2024.
November 25, 2020
FDA Call for Safety Details in Electromagnetic Device Applications
The applications should include a risk assessment and the results of electromagnetic compatibility testing, the agency said.
November 25, 2020
AMS Expands Into Wound Care Through Raleigh Purchase
Raleigh is the only independent British company that offers acrylic and silicone gel contract coating for wound-care products, AMS said.

Research and Development

November 25, 2020
Zeteo Biomedical Partners With Iowa State University on Nasal COVID-19 Vaccine
November 10, 2020
FDA Advisory Committee Shoots Down Neovasc’s Reducer Stent
November 10, 2020
Mesa Biotech Earns Additional BARDA Funding for Rapid COVID-19/Flu Test
November 9, 2020
Abbott’s COVID-19 Antigen Test Shows Promise for Asymptomatic Patients
October 29, 2020
PharmaJet’s Needleless Vaccine Injector Gets Picked for COVID-19 Vaccine Trial

Submissions and Approvals

November 24, 2020
FDA Clears AliveCor’s Electrocardiogram AI Suite
November 24, 2020
Rapid Medical’s Mesh Device Obtains CE Mark for Treating Cerebral Vasospasm
November 24, 2020
Baxter’s Remote Peritoneal Dialysis System Gets FDA OK
November 23, 2020
Lucira Health’s Rapid Home COVID-19 Test Gets EUA
November 23, 2020
Sofwave Medical Gets CE Mark and Israeli Clearance for Ultrasound Skin Therapy