Breaking the PCR-Only Barrier: Dual 510(k) Clearance and CLIA-Waiver Establish FINDER as the First Molecular Point-of-Care Platform with Multifunctional Capabilities

Baebies announced FDA 510(k) clearance and CLIA-waiver approval for the FINDER® Flu A&B/SARS-CoV-2 Test, an ultra-rapid ...
PharmiWeb

Point-of-Care Diagnostics Market: Advancing Rapid Testing and Decentralized Healthcare

Molecular Diagnostics Market is experiencing steady expansion, driven by the global shift toward rapid, decentralized, and ...
PCR

TD Synnex Maverick invests to accelerate partner growth

TD Synnex Maverick, the specialist collaboration, digital signage, and unified communications business within TD Synnex, has ...
360dx

Lex Dx Wins FDA 510(k) Clearance, CLIA Waiver for Point-of-Care PCR System, Respiratory Test

NEW YORK – Lex Diagnostics said on Monday that it has obtained 510(k) clearance and CLIA waiver from the US Food and Drug Administration for its Velo point-of-care molecular diagnostic system and an ...
Seeking Alpha

Anbio Biotechnology's Hype And Hard Approvals Suggest A Stretched Valuation

Anbio Biotechnology is a medical device firm specializing in in-vitro diagnostics, with recent stock volatility and a thin public float. I believe they continue to face significant regulatory hurdles ...
BioSpace

AMDI Submits 510(k) and CLIA Waiver Dual Submission to FDA

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 ...
360dx

AMDI Submits Multiplex Respiratory Test, MDx Instrument for FDA 510(k) Clearance, CLIA Waiver

NEW YORK – Autonomous Medical Devices Incorporated (AMDI) has submitted its Fast PCR Mini Respiratory Panel test and AMDI Fast PCR Instrument to the US Food and Drug Administration for 510(k) ...
Forbes

Investing In Place, Investing In People: PCR’s New Headquarters

Forbes contributors publish independent expert analyses and insights. I'm co-founder & CEO with 30+ years in community economic development. Aug 26, 2025, 11:37am EDT PCR Partners and Board Members at ...
KLFY News 10

Anbio Biotechnology Responds to Global Outbreaks with Chikungunya Rapid Test and New 15-Minute Ultra-Fast PCR System

Covering both mosquito-borne diseases and emerging respiratory pathogens, Anbio continues to advance point-of-care diagnostics for timely outbreak detection worldwide. FRANKFURT, Germany, Aug. 8, 2025 ...