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
Puerto Rico Medical Device Industry Still Reeling, Gottlieb Tells Congress October 26, 2017 A focus of the FDA’s efforts is maintaining electrical power for the factories. Read More
EMA Details Brexit Continuity Plan and Staff Retention Efforts October 25, 2017 The official selection of one of 19 potential host cities for the EMA is expected to be announced Nov. 20. Read More
FDA Posts Updated Inspection Manual Chapter October 25, 2017 The chapter covers medical devices, drugs, and biologics. 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
CDRH Extends Experiential Learning Program for 2018 October 24, 2017 The program gives the FDA staff a better understanding of the products they review. Read More
AdvaMed Petitions for Relief From India’s Device Price Caps October 24, 2017 India is considering price caps for other medical devices, such as orthopedic implants and catheters. 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