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
First U.S. Surgery With 3D-Printed Implant October 23, 2017 The team obtained permission to use the investigational device through the FDA’s expanded access program. 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