Caption Health’s AI Software Cleared July 30, 2020 The software offers “comparable performance to an expert quantitative measurement,” the company said. Read More
FDA Clears Neocis’ Dental Robotic System for Full Arch Implant Treatments July 30, 2020 In a clinical study, the robotic system reduced surgery time to an average of 21 minutes. Read More
Cerus Endovascular Gets CE Mark for Microcatheter July 29, 2020 The device offers “stability and control” for delivering larger and braided devices, the company said. Read More
Beckman Coulter’s Automated Blood Banking Analyzer Cleared by FDA July 29, 2020 The unit is now available in the United States, Canada and countries across Europe. Read More
Bruker Earns CE Mark for PCR COVID-19 Test July 29, 2020 The test demonstrated 100 percent accuracy in two clinical trials. Read More
NOWDiagnostics’ COVID-19 Antibody Test Cleared in Europe July 29, 2020 The company is evaluating the test in clinical trials for point-of-care and over-the-counter use. Read More
FDA Clears Stratus’ Cannula for Radiofrequency Heat-Lesion Procedures July 28, 2020 The device earned a CE mark in 2018 and has been used in thousands of procedures in Australia and Brazil. Read More
Rapid Medical Earns CE Mark for Blood Clot Retriever July 28, 2020 Despite its large adjusted size, the device can be delivered using a standard microcatheter with a 0.53mm internal diameter. Read More
Zebra Medical Gets 510(k) Clearance for Mammography Tool July 28, 2020 The product has already received a CE mark in Europe. Read More
Lacrivera Nabs CE Mark for Lacrimal Plug July 27, 2020 Lacrivera is launching the product in a range of sizes and in single-pair or 10-pair boxes. Read More
AngioDynamics Earns 510(k) Clearance and CE Mark for Implantable Port July 27, 2020 The company said it will immediately launch the product in the U.S. and Europe. Read More
DiaCarta Gets Emergency Use Authorization for COVID-19 Test Kit July 27, 2020 All printed materials with the kit must make clear that the test is only for emergency use by authorized laboratories, the agency said. Read More