Agency for Healthcare Research and Quality posts a final 1tech assessment on the "Quality, Regulation and Clinical Utility of Laboratory-developed Tests" on its website June 22. The report, largely unchanged from a draft document issued last August, was requested by CMS' Coverage and Analysis Group (2"The Gray Sheet" Aug. 24, 2009). The assessment concludes that establishing the quality of lab-developed tests is challenging and the lack of clinical validity or utility assessment is cause for concern. In particular, "given the dynamic nature of the molecular testing area, the assessments of the quality, regulation or utility of [lab-developed molecular tests] need to be frequently updated." FDA is seeking to finalize a comprehensive framework for oversight of lab-developed tests, with a public meeting on the matter scheduled for July 19-20 (3"The Gray Sheet" June 21, 2010)
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Medtronic announced it received expanded MRI labeling for its DBS systems, which is critical, given that almost 70% of all DBS-eligible patients will likely need an MRI at some point in their care, says Ashwini Sharan, CMO for Medtronic Neuromodulation.
In this episode, Medtech Insight reporter Natasha Barrow speaks to LungLife AI CEO Paul Pagano. Lung Life AI is a US-based AIM-listed medical technology company that has developed a liquid biopsy test for the early detection of lung cancer called Lung LB. Pagano runs through the highlights of Lung Life AI journey to date and its future ambition for a strategic partnership. He also provides advice to similar diagnostic companies seeking reimbursement andcompliance with the US FDA Lab Developed Test ruling.
Dxcover sets up new Clinical Laboratory Improvement Amendments (CLIA) lab in Franklin, Tennessee.
EnsoData positions itself as device-agnostic and interoperable, with FDA-cleared software that can integrate with all major devices. CEO Mortara said this flexibility helps maximize patient reach by enabling both direct provider engagement and integration with device manufacturers.
After multiple warning letters and safety communications, the US FDA has decided to block the import of certain endoscopes from Olympus. In total, the agency’s action pertains to 58 device models manufactured by the Japanese firm used in urinary, respiratory, abdominal and pelvic procedures.
