FDA published a proposed rule that would regulate IVDs, including LDTs, as medical devices, drastically altering the regulatory landscape for LDTs. The proposed rule would update the definition of ...

The U.S. Food and Drug Administration recently released the guidance “Oncology Drug Products Used with Certain In Vitro Diagnostic Tests: Pilot Program,” laying out the process by which FDA will offer ...

insights from industryLaura NeaVP of Quality and Regulatory ManagementTecan In this interview, News-Medical talks to Laura Nea, Vice President of Quality and Regulatory Management at Tecan, about the ...

The "A Regulatory Update on the Medical Device and In-Vitro Diagnostic Regulations in the EU (European Union) and UK Training Course (Apr 29, 2026)" training has been added to ResearchAndMarkets.com's ...

Bharat Book Bureau has announced the addition of the "Global In-Vitro Diagnostics (IVD) Market: Analysis and Forecast 2017-2023 (Focus on Product Type, Test Type ...

The in vitro diagnostics industry is expected to undergo a transformation. Learn more about the potential disruptors and what IVD companies can do to keep pace. Karl-Hubertus Gruber, Dr. Michael ...

Add Yahoo as a preferred source to see more of our stories on Google. Remote patient monitoring (RPM) employs digital technologies and services to collect, analyse, and transmit patients’ health data ...

DUBLIN--(BUSINESS WIRE)--The "The Role of the Person Responsible for Regulatory Compliance (PRRC) Under the MDR (Medical Device Regulation) and IVDR (In-Vitro Diagnostic Regulation) Training Course" ...

Accelerate Diagnostics, Inc. AXDX has initiated a collaboration and quality agreement with Bruker Corporation BRKR. The deal will help the company advance in vitro diagnostics in microbiology. With ...

Tempus AI Inc. shares rose after it said it received 510(k) clearance from the Food and Drug Administration for its RNA-based in vitro diagnostic device. Its stock recently rose 5.2% to $92.85 in ...

Dublin, Jan. 08, 2020 (GLOBE NEWSWIRE) -- The "Global In Vitro Diagnostics (IVD) Market: Analysis By Product (Medical Devices, Reagents and Kits, Services), By Technology, Application, End User, By ...