iCAD Granted CE Mark for Breast Cancer Detection Device March 2, 2018 The device is compatible with Hologic, GE and Siemens systems. Read More
FDA Approves BD Onclarity HPV Assay March 2, 2018 The automated laboratory test is used on BD’s Viper LT system. Read More
Pure-Vu System Earns CE Mark February 28, 2018 The company received a CE mark based on positive clinical study results reported last November. Read More
Medtronic Wins FDA Nod for Guardian Sensor February 27, 2018 The system uses Medtronic’s SmartGuard algorithm to automatically adjust insulin delivery. Read More
Endomag’s Magseed Marker Cleared for Long-Term and Soft Tissue Implantation February 27, 2018 The system is designed to guide the accurate removal of cancer. Read More
Getinge Wins 510(k) Clearance for PulsioFlex Monitoring System February 27, 2018 The system provides cardiac output measurement both continuously and intermittently. Read More
Reva Receives CE Mark for Fantom Encore Bioresorbable Scaffold February 26, 2018 REVA expects to launch the entire product line later this year. Read More
Siemens Healthineers Receives FDA Clearance for MRI Application February 23, 2018 The device is available for the MAGNETOM Aera 1.5T and Skyra 3T MRI scanners. Read More
Alfa Scientific Designs Wins 510(k) Clearance for Fecal Blood Test February 22, 2018 Early diagnosis of colorectal cancer yields a 90 percent cure rate. Read More
MemoryMD Gets FDA Clearance for Wireless EEG Amplifier February 22, 2018 The technology can also make neurologists' offices more efficient, cutting the time for EEGs. Read More
FDA Grants EAP Designation to Guardant's NGS-Based Liquid Biopsy February 21, 2018 The company plans to submit a PMA to the FDA for the assay by year end. Read More
FDA Updates its Global Unique Device Identification Database February 21, 2018 The FDA made updates based on feedback and requests from medical device manufacturers. Read More