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 ...
The Scientist

The History and Evolution of PCR

Explore 40 years of PCR history, from Kary Mullis’s invention story to the rise of digital PCR and how it revolutionized ...
Oklahoma's News

Seegene unveils the world's first unattended PCR automation, igniting a global diagnostic paradigm shift at ADLM 2025

Fully Unmanned— CURECA™, the 100% Automated Diagnostic System Defining the Future Gold Standard, Debuts in Chicago, July 28–31 Unifying global diagnostic data - STAgora™, the big data platform set to ...
Seeking Alpha

Co-Diagnostics, Inc. Submits First FDA 510(k) Application for Co-Dx PCR Pro Platform

The Company expects that the application for OTC clearance will shortly be followed by pursuit of POC clearance, with other tests in the pipeline to meet the needs of a global market SALT LAKE CITY, ...
MarketWatch

Visby Medical Receives Landmark FDA De Novo Authorization for First-Ever OTC PCR Test for Sexual Health

SAN JOSE, Calif., March 28, 2025 /PRNewswire/ -- Today, Visby Medical(TM), a leading innovator in medical diagnostics, announced that the U.S. Food and Drug Administration (FDA) has granted De Novo ...
Business Wire

Stilla Launches Access Program for Industry’s First Six-Color Digital PCR System

BOSTON & PARIS--(BUSINESS WIRE)--Stilla Technologies, the company innovating the next generation of digital PCR solutions for life science research and molecular diagnostics, is pleased to announce ...
Business Wire

Visby Engages Quest and Labcorp to Broaden Consumer Access to First At-Home, FDA-Authorized PCR Test for STIs

SAN JOSE, Calif.--(BUSINESS WIRE)--Today, Visby Medical announced two new relationships that will expand national access to the Visby Women’s Sexual Health Test, the first, at-home, FDA-authorized PCR ...