As discussed in the final guidance, FDA anticipates that the agency and industry will need up to 60 days after the publication of this guidance to operationalize the recommendations discussed; however ...

On January 7, 2025, FDA published a draft guidance titled “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations.” The draft guidance ...

CollaborateMD, a cloud-based revenue cycle management solutions company, is releasing its real-time claims submission and editing software this spring. The new software will allow users to submit ...

LEHI, Utah--(BUSINESS WIRE)--Owlet, Inc. (NYSE: OWLT) (the “Company”) announces that the U.S. Food and Drug Administration (“FDA”) has accepted for substantive review the Company’s de novo ...