Magellan Diagnostics Distributed Unapproved Testing Systems, FDA Says October 27, 2017 Magellan, a subsidiary of Meridian Bioscience, received a Form 483 after an FDA inspection revealed significant violations. Read More
FDA Clarifies When New 510(k)s Are Required for Device Updates October 27, 2017 The agency issued separate guidance for software. Read More
Medineering Wins CE Mark for Its Positioning Arm October 26, 2017 The technology is designed to assist surgeons in complex anatomical areas. Read More
Renishaw Wins FDA Approval for Neurosurgery Planning Software October 26, 2017 Neurosurgeons can use the software to create plans based on procedure type. Read More
Abbott Wins Marketing Clearance for First Smartphone-Compatible Cardiac Monitor October 25, 2017 The data collected are transmitted to a physician via a mobile app. Read More
FDA Approves New Nebulizer for Tyvaso Inhalation System October 25, 2017 Tyvaso was originally approved by the FDA for the treatment of pulmonary arterial hypertension in 2009. Read More
Implanet Receives CE Mark for JAZZ Passer October 24, 2017 The product received 510(k) marketing clearance from the FDA in September. Read More
Quidel Receives FDA Clearance for Solana Assay October 24, 2017 The assay received a CE Mark in August. Read More
DarioHealth Gains CE Mark for iPhone-Compatible Smart Glucose Meter October 23, 2017 DarioHealth seeks approval in the U.S., Canada, and Australia. Read More
Pear Therapeutics Receives Expedited Access Pathway Designation October 23, 2017 Clinical trials of the device demonstrated improved abstinence. Read More
Creavo Medical Secures 510(k) Clearance for Vitalscan October 23, 2017 Vitalscan is portable medical device measures activity. Read More
Australia Approves Anika’s Monovisc for Treatment of Osteoarthritis Pain October 20, 2017 The product recently received approval in India and Taiwan. Read More