FDA Clears Spectral Medical Stand-Alone Pump December 26, 2017 The company plans to seek additional clearance for the product as an open platform hemoperfusion delivery device. Read More
Avinger Image-Guided Atherectomy Device Gets CE Mark December 26, 2017 The device enables surgeons to see inside the artery via the company’s Lightbox console instead of through x-ray. Read More
Senzime’s OnZurf Probe Scores CE Mark December 22, 2017 The device can monitor postsurgical healing and flag warning signs of post-operative complications. Read More
FDA Clears Laser Endomicroscopy Platform December 22, 2017 The College of American Pathologists reported high potential value for in vivo microscopy. Read More
TGA Signs Off on Glucose Monitor for iPhones December 22, 2017 Sales of the device in Australia will begin in January. Read More
FDA Grants Early Marketing Approval to Biom’Up Flagship Device December 22, 2017 The company plans to market the device in the United States by next summer. Read More
French Device Firm Snags CE Mark for Smart Sensor December 21, 2017 The device captures treatment information, including insulin dosages, and sends the data to a patient monitoring mobile app. Read More
K2M Group Receives CE Mark for 3D-Printed Expandable Cage System December 21, 2017 The system is designed to stabilize the cervical spine in patients needing treatment for trauma or tumors. Read More
German Devicemaker Gets CE-IVD Mark for Lung Cancer Assay December 21, 2017 The European Commission provided funding for the assay’s development. Read More
FDA Clears XableCath Blunt Tip Catheter December 21, 2017 The device will be used in the first U.S. surgical procedures during the first half of 2018. Read More
FDA to Require Agency-Wide Training in Use of Patient-Reported Outcomes December 20, 2017 A first-of-its-kind CDRH report lists the benefits to industry in using PROs. Read More
FDA to Harmonize Adverse Event Codes With IMDRF Terminology December 18, 2017 eMDR deployment is currently set for April 6, 2018. Read More