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.
The US’ foreign trading partners are not working hard enough to secure bilateral deals, says US President Donald Trump, who will introduce new reciprocal tariffs on Aug. 7. MedTech Europe stresses that patients will suffer if medtech is not excluded from the tariffs.
Philips Respironics has updated instructions for use for three ventilators that were included in a May 2024 recall. The company also added three potential injuries and one death to the original number.
Ultromics has secured $55m in Series C funding to advance its AI tool, EchoGo, which detects undiagnosed heart failure. The company's focus on diseases with available treatments resonated with investors.
