Masimo’s Wearable Vital Signs Monitor Gains CE Mark November 3, 2020 The company is initiating a limited European market release of the monitor. Read More
Boston Scientific’s Drug-Coated Balloon Gets FDA Clearance November 3, 2020 The Ranger drug-coated balloon has been cleared in Europe since 2014, and the company plans to immediately launch it in the U.S. Read More
DiA Imaging Analysis Receives 510(k) Clearance for Cardiac Ultrasound AI November 2, 2020 The AI solution works with the company’s other cardiac analysis products. Read More
Medtronic Gets FDA OK for Nerve-Monitoring System November 2, 2020 The system helps to improve efficiency and accuracy during surgeries. Read More
MMI Earns CE Mark for Robotic Microsurgery System October 30, 2020 The robotic device successfully performed its first four surgeries in Florence, Italy. Read More
Nvision Gets FDA Clearance for Osteotomy Wedge System October 30, 2020 The implant encourages multidirectional bone healing and improved fixation. Read More
Precision Biomonitoring’s COVID-19 Test Cleared in Europe October 30, 2020 The product includes 96 pre-loaded tests and is compatible with most laboratory instruments, Precision Biomonitoring said. Read More
DiaSorin’s COVID-19 Rapid Antigen Test CE Marked October 28, 2020 DiaSorin said it will be capable of producing up to 10 million of the tests per month soon after it launches the product. Read More
Medtronic’s Self-Expanding Venous Stent Gets FDA Clearance October 28, 2020 The device received a CE mark certification in April 2017 and is designed to be permanently implanted. Read More
Orthos Gains CE Mark for COVID-19 Antigen Test October 28, 2020 The company has also applied for an Emergency Use Authorization from the FDA. Read More
C4 Imaging’s Nonmetallic MRI Marker Cleared October 28, 2020 The marker creates a reference point that can be used to guide procedures, such as the treatment of cancer using radiotherapy. Read More
FDA Clears Abiomed’s Cardiopulmonary Bypass System October 27, 2020 Users must have specialized training in extracorporeal circulation therapy. Read More