The document follows the agency’s first digital health advisory meeting and a final guidance on postmarket updates to AI ...

Alleviant Medical announced that it received FDA investigational device exemption and breakthrough device designation for its ...

Both President Biden, and incoming President Trump, have made AI a top priority, and now the U.S. Food and Drug ...

The Medtronic Harmony transcatheter pulmonary valve system provides a minimally invasive alternative for congenital heart ...

Carotid artery stents are specialized devices used in carotid artery stenting (CAS) procedures to widen narrowed arteries, thereby improving blood flow and preventing plaque ... gaining access to ...

This document will help sponsors prepare a submission for a notice of compliance for a public health emergency drug under the regulations. It also outlines the process for meeting the post-market ...

medial devices, ethics committee, vaccines and cosmetics. The SUGAM registration provides an opportunity for the user to apply for the licenses through the online licensing system. Let us look in ...

Decluttering, strategic placement, and color choices optimize energy flow. Adding plants ... harmonious and inspiring work environment. Even devices can get a feng shui makeover.

Note: The expired drugs stored to claim a rebate from the income tax will not be considered an offence under the act unless not intended for sale. Documents for the qualified person (for Wholesale ...

Drug, and Cosmetic Act added by Congress in 2022], and we do recommend in our pre-market guidance that manufacturers make sure devices are patchable. Eventually, the devices that we approve today will ...