Nasdaq

Spectral AI Submits De Novo 510k Application to FDA for DeepView® System Designed for Burn Care Diagnostics

Spectral AI submitted a De Novo 510k application for its DeepView System to the FDA, aimed at enhancing burn care. Spectral AI has announced the submission of its De Novo 510k marketing clearance ...
MarketScreener

Optiscan Imaging Limited Lodges U.S. FDA 510(K) Application for Invue Precision Surgery Device

Optiscan Imaging Limited announced the successful submission of a 510(k) application with the United States Food and Drug Administration ('FDA') for the Optiscan InVue(TM) precision surgery device.
RAPS

FDA Finalizes Guidances on CLIA Waiver Applications, 510(k) Dual Submissions

The US Food and Drug Administration (FDA) on Tuesday finalized two guidances providing recommendation for diagnostics makers looking to submit Clinical Laboratories Improvement Amendments (CLIA) ...
National Academies of Sciences%2c Engineering%2c and Medicine

Public Health Effectiveness of the FDA 510(k) Clearance Process: Balancing Patient Safety and Innovation: Workshop Report

To gain a foundation on which to build its discussions, the committee commissioned two former Center for Devices and Radiological Health (CDRH) staff to draft a background paper on the 510(k) or ...
National Academies of Sciences%2c Engineering%2c and Medicine

Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years

As noted in Chapter 1, the committee was charged by the Food and Drug Administration (FDA) to review the 510(k) clearance process and answer two principal questions: Does the current 510(k) clearance ...