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) ...

The US Food and Drug Administration (FDA) on Friday began posting decision summaries for its Clinical Laboratory Improvement Amendments (CLIA) waiver decisions for in vitro diagnostics (IVDs) as part ...

HAUPPAUGE, N.Y., Nov. 28, 2022 (GLOBE NEWSWIRE) -- Chembio Diagnostics, Inc. (Nasdaq: CEMI), a leading point-of-care diagnostics company focused on infectious diseases, today announced the submission ...

SAN DIEGO, CA - June 24, 2025 (NEWMEDIAWIRE) - Axim Biotechnologies, Inc. (OTCQB: AXIM), a leading developer of rapid diagnostic testing for ocular and systemic conditions, today announced that it has ...

The Centers for Medicare and Medicaid Services (CMS) announced that the Clinical Laboratory Improvement Amendments (CLIA) program will be paperless as of March 1, 2026. After this date, CMS will no ...

Stockhead’s Tylah Tully looks at news from Lumos Diagnostics (ASX:LDX), who has submitted its application to the FDA for CLIA waiver approval for FebriDx, a rapid point-of-care diagnostic test to ...

SANTA ANA, Calif., Sept. 15, 2025 /PRNewswire/ -- Today, Autonomous Medical Devices Incorporated (AMDI) announced its submission to the US Food and Drug Administration (FDA) of a dual 510(k) and CLIA ...

Dwight Egan (Chairman, CEO & President) framed Q2 as “another important step in our transition from platform development toward commercialization,” emphasizing “advancing regulatory milestones, ...

BETHLEHEM, Pa., March 23, 2011 (GLOBE NEWSWIRE) -- OraSure Technologies, Inc. (Nasdaq:OSUR) announced today that it has submitted to the U.S. Food and Drug Administration ("FDA") an application for a ...

With the spread of COVID-19, healthcare providers—including those that are more easily accessible to patients, like primary care practices and urgent care clinics—are looking for fast and reliable ...