The FDA sent an early safety alert warning clinicians of deployment failures with certain Boston Scientific AXIOS Stent and ...
A major American medical device manufacturer is investing $110 million to expand production in Nebraska as part of an effort to restore pharmaceutical manufacturing and improve ...
Minneapolis-based Imricor Medical Systems said it won 510(k) clearance from the FDA for its Vision-MR Diagnostic Catheter.
Medtronic said Monday it received 510 (k) clearance from the Food and Drug Administration for an app to connect its smart ...
The Naox Link system uses soft, biocompatible in-ear electrodes integrated into wired earbuds to acquire, record, and ...
Medical Device Network on MSN
CSA Medical submits application to FDA for RejuvenAir System
The system aims to address underlying chronic cough and issues with mucus production and clearance in chronic bronchitis.
Johnson & Johnson’s filing comes a month after Medtronic gained U.S. clearance for its Hugo system as competition in the soft ...
FDA nonmedical wearable health data devices providing general health info will not face regulation, clarifying guidance for ...
The FDA will ease regulation of digital health products, aiming to deregulate AI and promote its widespread use.
FDA announces wearable devices providing non-medical info won't face regulation, offering clarity on digital health ...
The Bethlehem-based maker of at-home diagnostic tests said it submitted two separate applications to the FDA at the end of ...
The chief medical officer is interested in an easier path to market for health screening features in wearable devices.
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