Nasdaq

Intelligent Bio Solutions Inc. Submits FDA 510(k) Application for Intelligent Fingerprinting Drug Screening System

Intelligent Bio Solutions Inc. (INBS) has submitted a 510(k) premarket notification to the FDA for its Intelligent Fingerprinting Drug Screening System, a rapid and non-invasive drug testing method ...
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 ...
RAPS

New guidances outline eSTAR submission requirements for de novo and 510(k) device applications

The US Food and Drug Administration is one step closer to requiring electronic submission of all premarket applications for both 510(k) and de novo medical devices, according to two newly released ...
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

The US Food and Drug Administration (FDA), through its Center for Devices and Radiological Health (CDRH), regulates medical devices and radiation-emitting products. 1 The 510(k) clearance process, ...
Business Insider

Radical™ Catheter Technologies Announces U.S. FDA 510(k) Clearance for its 6F Neurovascular Catheter -- Broadening Access Across a Wide Range of Applications

LOS GATOS, Calif., April 13, 2026 (GLOBE NEWSWIRE) -- Radical™ Catheter Technologies, a NeuroTechnology Investors (NTI) portfolio company, today announced the U.S. Food and Drug Administration (FDA) ...
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 ...