Health Advances’ Post

Next week! Join Dr. Young Wang, MD, and Dr. Ingela Mauritzon, PhD, as they walk through the intricacies of in vitro diagnostics (IVD). Upon completion, attendees will be able to: • Understand the significance of regulatory harmonization in IVD • Identify common challenges and pain point • Gain access to valuable resources for ongoing learning Enroll today (with or without contact hours) > https://bit.ly/3RV3Sm5 #ACRP #Webinar #ContinuingEducation #InVitroDiagnostics #IVD

We are excited to introduce our new LinkedIn page dedicated to In Vitro Diagnostics (IVD). Stay tuned for key regulatory updates, industry news, and expert perspectives as we navigate the dynamic landscape of IVDs. Find out more on In Vitro Diagnostics on our dedicated webpage: https://bit.ly/45GEXsN #BSI #IVD #IVDR #RegulatoryCompliance

Follow our new LinkedIn page for everything IVD related.

This was a really nice summary of FDA proposed regulation ove LDTs. Although I understand the intention, the implementation, even with an extended phase out period, is going to be a nightmare. And we saw how they handled covid EUA applications, which weren’t full 510k submissions & they couldn’t get through them in a timely manner, along with poor decision making in their part to draw sensitivity comparisons between rapid test & PCR as false negatives. As a result we had people waiting days to get test results back & then testing positive for months clearing viral RNA when they were no longer infectious. Hmmm. Rapid tests were the way to go the entire time. We had multiple clients in RADx that received $, they submitted & their tests never got fully reviewed. Crickets from FDA. Now imaging tens of thousands of tests being submitted at once… 🤦♂️

I'm so excited about this newly announced collaboration between Roche and PathAI which will combine the power of companion diagnostic biomarkers and AI to continue to advance patient care. Medicine just continues to get better and better! #pathology #ai #roche #pathai #diagnostics #oncology #medicine #digitalpathology #patientcare #precisionmedicine #personalizedmedicine

You’ve done so much to get to the finish line, but find one final hurdle: regulatory approval. When launching an in vitro diagnostic, sponsors can avoid barriers to success… That means millions of dollars and years of development can move forward – get our insights: https://bit.ly/3JxCG85 #RegulatoryApprovals #InVitroDiagnostics #PremierConsulting

The results of in vitro diagnostic tests influence up to 70% of clinical decisions, despite representing only 0.8% of total healthcare expenses. The importance of these tests lies in their ability to provide rapid and precise information, enabling healthcare professionals to make timely and targeted decisions that directly impact the effectiveness of treatments, the selection of therapies, and the optimization of healthcare resources. In this context, In Vitro Diagnostics Devices play a crucial role. The accuracy and reliability of Anicrin IVD Devices ensure accurate and consistent diagnostic results. #anicrin #IVD #diagnostics #labs

The EU’s new In Vitro Diagnostic Regulation (IVDR) introduces significant changes for in vitro diagnostic (IVD) manufacturers, including the requirement for clinical and scientific evidence to support products’ validity. To ensure continued access to the European market for IVDs, read this comprehensive review of the regulatory changes, transition timelines and actions to remain compliant.

The EU’s new In Vitro Diagnostic Regulation (IVDR) introduces significant changes for in vitro diagnostic (IVD) manufacturers, including the requirement for clinical and scientific evidence to support products’ validity. To ensure continued access to the European market for IVDs, read this comprehensive review of the regulatory changes, transition timelines and actions to remain compliant.

The EU’s new In Vitro Diagnostic Regulation (IVDR) introduces significant changes for in vitro diagnostic (IVD) manufacturers, including the requirement for clinical and scientific evidence to support products’ validity. To ensure continued access to the European market for IVDs, read this comprehensive review of the regulatory changes, transition timelines and actions to remain compliant.