CMS proposes national non-coverage for infrared therapy devices July 26, due to insufficient evidence that the treatment is reasonable and necessary for beneficiaries with peripheral neuropathy, skin ulcers and related conditions. The agency cites poor quality, small sample size and "a significant placebo effect" in the available clinical studies. "Only when basic efficacy has been established can investigators determine through additional studies which populations, if any, might benefit from experimental light therapy," the agency writes. CMS generated the national coverage decision internally, in part due to an FDA warning letter concerning burns from the Anodyne Therapy device (1"The Gray Sheet" Feb. 6, 2006, p. 5). Comments on the proposed decision are due Aug. 25...
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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 FDA has given up on its effort to regulate lab-developed tests as medical devices, at least for now. The agency will not appeal a decision from the Eastern District of Texas that tossed out the FDA’s final rule, leaving the agency with few cards.
Abbott received the US FDA nod for its Tendyne system, offering a minimally invasive alternative to replace the valves of patients with severe mitral valve disease who are at risk for open-heart surgery.
SAGA Diagnostics has launched its breast cancer residual and recurrence detection test – Pathlight – in the US. The test’s ultrahigh sensitivity and specificity is rare to see in oncology, the company claimed.
