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Featured POCT & Diagnostic Reagent Exhibitors
2025-07-01
Here are the standout players in POCT (Point-of-Care Testing) and rapid diagnostic reagents showcased at WHX Miami 2025, with a spotlight on innovative immunoassay solutions akin to alternating s...
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reclassifying hepatitis B and syphilis tests
2025-06-24
《FDA Advances Home‑Use Diagnostic Landscape: Reclassification & Support for POCT》-style report on the FDA’s recent POCT‑focused regulatory shifts — especially reclassifying hepatitis ...
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WHX Miami 2025 — A Global Hub for Medical Device Innovation & Trade
2025-06-16
Here’s a polished English news-style summary of WHX Miami 2025 (formerly FIME) with key highlights and context:
Event Overview
WHX Miami 2025, the rebranded Florida International Medical E...
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FDA Accelerates Home Test Approvals: POCT Is the Future
2025-06-11
1：Policy Shift: Home Diagnostics Enter the Fast Lane
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THC in Pets? What Most Owners Don’t Realize
2025-06-05
Unseen Risks, Subtle Symptoms, and the Need for At-Home Testing
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Understand in 10 Minutes: Home Test vs. Lab Test — What Really Sets Them Apart
2025-06-11
Many assume home testing is “less accurate” or “unprofessional.” In fact, certified home-use kits rely on the same biological principles as lab-based tests—only the sc...
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FDA-Cleared 12-Panel At-Home Drug Test Kit Empowers Families and Workplaces with Rapid Screening
2025-06-01
Conlight Diagnostics launches an FDA 510(k)-cleared immunoassay urine cup test, enabling self-administered screening for 12 common drugs of abuse in under 10 minutes.
Shanghai, China – June ...
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The In Vitro Diagnostic Regulation (IVDR) replaced the IVDD and entered into force on 26 May 2017 with 26 May 2022 as date of application
2025-05-16
In March 2023, the IVDR was amended as regards to transitional provisions for certain in vitro diagnostic (IVD) medical devices on Article 110(4) with the removal of the sell-off period to prevent ...
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The Shift from IVDD to IVDR—and the Challenges
2025-05-08
The shift from IVDD to IVDR represents a major change in how the IVD industry is regulated. While the EU Commission maintains that the system’s overall structure and approach remain consist...
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