District Court Overturns FDA’s LDT Rule: What the Ruling Means for Clinical Labs Now
Christine P. Bump
Under the district court’s vacatur, the LDT final rule and its compliance deadlines are no longer in effect and cannot be enforced
medical devices
Minimally Invasive Approach Could Change Standard of Care for Normal Pressure Hydrocephalus
Dan Levangie
New treatments are moving away from open surgery and toward minimally invasive techniques
EU IVDR 2017/746: Impact to Clinical Laboratories and Drug Developers
David Latto, PhD, Jill Haizlip, BS, MBA
How central labs can mitigate IVDR impact
Ensuring Precision in Dose Accuracy Verification
Sartorius
Solutions for mitigating error and improving precision in dose accuracy testing
What Latest EU 2024/1860 Amendment Means for IVD Manufacturers
Oliver Eikenberg, PhD
Key deadlines and questions in vitro diagnostic manufacturers need to consider to comply with IVDR Amendment EU 2024/1860
QIAGEN Receives EU IVDR Certification for QIAstat-Dx Syndromic Testing Instruments and Assays
QIAGEN
Product line earns CE-marking under new EU IVDR framework—including QIAstat-Dx Analyzer, QIAstat-Dx Rise and panels for detection of gastrointestinal and respiratory infections
FDA Releases New Principles for Machine Learning-Enabled Medical Devices
U.S. Food and Drug Administration
The new guiding principles promote transparency to build trust and improve the user experience of machine learning-enabled medical devices
World’s Fastest COVID-19 Test Is Here!
University of Bath
Compact, lab-on-a-chip genetic testing device detects SARS-CoV-2 in nasal swab samples within minutes
Portable Device Enables Rapid On-Site Detection of SARS-CoV-2
American Society for Microbiology
The device helps detect SARS-CoV-2 at points of care and in areas with barriers to health care
The Impact of New Regulations on IVD Manufacturing
Sartorius
Learn how the new IVDR (in vitro diagnostic regulation) rules affect future innovations