In Vitro Diagnostics

The College of American Pathologists wants a US district court to scrap the FDA’s final rule that unilaterally assumes oversight of lab-developed tests, but not because the college feels the agency has no business regulating them. Helena Duncan, senior director of quality at CAP, explained the college’s position to Medtech Insight.

The European Parliament intends to send an official message to the European Commission to try and push for an early revision of the Medical Device Regulation.

Marabio Systems says the new funding will help accelerate efforts to bring a blood test to market in 2025 that will accurately determine if a mother is a carrier of antibodies that cause MARA, a subtype of autism that believe to cause more severe behavior.

The European Commission’s proposed timeframe for revising the MDR and IVDR is far too long, Parliament believes, and is resulting in increasingly outdated products in healthcare establishments around European threatening patient care.

Having 50 notified bodies under the Medical Device Regulation is a landmark achievement for the EU after a long and slow, journey to reach this point.

Just as manufacturers need to implement corrective and preventive action plans, so this is an essential part of how a notified body functions; new guidance explains how.

In the latest episode of the In Vivo podcast, Russ Lebovitz, the co-founder and scientist behind San Diego's Amprion Diagnostics, discusses the role alpha-synuclein misfolding plays in neurodegenerative diseases and how early alpha-synuclein testing could mitigate the impacts of conditions ranging from Parkinson's disease to Lewy body dementia. 

This week, Establishment Labs Holdings announced the FDA gave it premarket approval for Motiva breast implant, Cologuard lands FDA approval for Cologuard Plus and GE HealthCare gets FDA nod for a new imaging agent. The FDA announces another expansion for TAP into ophthalmology and radiology. The AAMI and CTA will join forces to develop standards for AI and ML-enabled health care products.  

The owner of a Chicago COVID-19 testing lab plead guilty to wire fraud for billing the government for COVID-19 tests that were not performed. Also, test developer Talis Biomedical agreed to pay $32.5m to settle a shareholder suit.

There is to be more rigorous testing from now on for high-risk IVDs. Measures are also in place to prevent device shortages during the transition to new rules.