US FDA explains clinical study, pre-market requirements for computer-assisted detection devices

06 Jul 2012

The US Food and Drug Administration has issued updated versions of two related guidelines on computer-assisted detection (CADe) devices applied to radiology images and radiology device data. The guidelines explain how manufacturers should design and conduct clinical performance studies, and submit pre-market notification, or 510(k), applications for these products.

Drafts of the documents were issued for stakeholder consultation in October 2009; these have been updated in light of comments...

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Panel: FDA’s Home Healthcare Initiative Holds Promise, But Challenges Remain

06 Jun 2025

• By Elizabeth Orr

During a recent FDLI panel, experts discussed the FDA's Home Healthcare initiative, highlighting its potential benefits and challenges. Key issues include usability testing, reimbursement, labeling for home use, and the need for innovation while ensuring patient safety.