Summary of PMA Originals & Supplements Approved
Originals: 2
Supplements: 60
Summary of PMA Originals Under Review
Total Under Review: 52
Total Active: 18
Total On Hold: 34
The Medical Device Business Journal — Medical Device News & Articles | MassDevice
FDA | Recalls | 510(k) | Pre-Market Approvals | MDSAP | Clinical Trials
Summary of PMA Originals & Supplements Approved
Originals: 2
Supplements: 60
Summary of PMA Originals Under Review
Total Under Review: 52
Total Active: 18
Total On Hold: 34
California medtech company Direct Flow Medical notched some major milestones today, announcing a European regulatory win and completed enrollment in a U.S. feasibility trial for its transcatheter aortic valve implantation systems.
Massachusetts medical device maker Ocular Therapeutix announced today that it won FDA premarket approval for its flagship ReSure sealant, a hydrogel designed to help heal surgical wounds in the eye.
In newly released guidance documents FDA regulators for the 1st time laid out separate 510(k) application recommendations for blood glucose meters intended for over-the-counter patient use and those designed for professional healthcare settings.
Inspire Medical Systems is getting the FDA treatment, landing a date next month with the Anesthesiology & Respiratory Therapy Devices panel to undergo review of the company’s implanted Inspire II Upper Airway Stimulator for treatment of obstructive sleep apnea.
New York mHealth company Kinsa this month touted FDA 510(k) clearance for its Kinsa thermometer, the 1st U.S.-approved oral smartphone-connected thermometer.
The thin and compact Kinsa "smart" thermometer connects to the headphone jack of smartphones and other mobile devices. The display shows readings and alerts users if the thermometer slips out of place.
By Stewart Eisenhart, Emergo Group
Siemens (NYSE:SI) won 510(k) clearance for its Magnetom Prisma 3 Tesla MRI System.
The high-resolution Magnetom Prisma includes features that cut down on vibrations and produce high-quality images, down to fine anatomical details of the brain. Siemens is offering on-site upgrades to customers who already have the Magnetom Trio, another 3T MRI system.
Samsung Electronics (LON:BC94) said it landed 510(k) clearance from the FDA for its S Health app.
The S Health app pulls biometric variables from 3rd-party devices, including calories burned, projected heart rate, blood glucose, blood pressure and sleep efficiency.
By Stewart Eisenhart, Emergo Group