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
medical devices
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
What Health Care Supplies Might We Run Out of Next?
Zahraa Chorghay, PhD
From the pandemic to geopolitical conflict, supply chain disruptions strain health care
The IVDR Deadline: How Will It Impact the Diagnostics Industry?
Manoj Gandhi, MD, PhD
On May 26, the 1998 IVDD becomes obsolete after a five-year transition to the EU’s IVDR process
Simulated Patients Can Reduce Time and Cost of Clinical Trials
Erica Tennenhouse, PhD
Researchers successfully replicated the outcomes of traditional clinical trials of a medical device using virtual patient populations
"Sweat Sticker" Diagnoses Cystic Fibrosis on the Skin in Real Time
Northwestern University
New wearable device changes color to detect early disease marker in newborns' sweat