BioMérieux Wins FDA Clearance for BioFire’s FilmArray Respiratory Panel 2 June 1, 2017 The FilmArray RP2 advances the existing FilmArray respiratory panel by reducing the assay time. Read More
OrthoAccel's AcceleDent Optima Gains FDA Clearance June 1, 2017 The orthodontic device directly connects patients and practices with usage monitoring. Read More
FDA Clears GenePOC’s Revogene Instrument and GBS LB Test June 1, 2017 The assay detects Streptococcus colonization. Read More
SpaceOAR System Acquires Shonin Approval in Japan May 31, 2017 SpaceOAR hydrogel is an absorbable prostate-rectum spacer that reduces rectal injury during prostate radiotherapy. Read More
Bayer Wins FDA Clearance of myBETAapp and Betaconnect Navigator May 31, 2017 The autoinjector is used to administer Betaseron. Read More
Atonomics Gains CE Mark For Trace Lipids Test Panel May 31, 2017 The lipids panel determines total cholesterol. Read More
Intuitive Surgical Achieves FDA Clearance for Robotic-Assisted Surgical System May 31, 2017 The da Vinci X System will be available for sale in the U.S. later this year. Read More
FDA Should Require More Labeling of Emergency Zika Diagnostics: GAO May 30, 2017 Some performance characteristics were not consistently reported across different tests, making it more challenging to compare them. Read More
Masimo Wins FDA Clearance of O3 Regional Oximetry for Pediatric Patients May 30, 2017 The device is already indicated for adults. Read More
Ra Medical Systems Achieves FDA Clearance For Peripheral Artery Disease Treatment May 30, 2017 The device is a catheter and laser system for the treatment of arterial blockages in the lower vessels. Read More
Stimwave Receives CE Mark Approval for Percutaneous Stimulator Anchoring System May 30, 2017 The injectable anchor is used in conjunction with the company’s wireless neurostimulator devices. Read More
Magellan Recalls Lead Testing Systems Over Accuracy Concerns May 29, 2017 Company announces recall against backdrop of FDA safety communication. Read More