Coverage with evidence for stem cell transplants?: CMS proposes May 6 to allow coverage with evidence development for allogeneic hematopoietic stem cell transplantation for myelodysplastic syndrome, a group of diverse blood disorders in which the bone marrow does not produce enough healthy, functioning blood cells (1"The Gray Sheet" Nov. 30, 2009). The proposed coverage memo outlines criteria for prospective controlled clinical studies, including the need to address specified treatment outcomes and to adhere to strict standards of scientific integrity. CMS is taking comments through June 5 and plans a final rule by Aug. 4
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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.
A Japanese study of Watchman LAA closure devices found that leaks of any size after implantation raise the risk of stroke. The study comes shortly after the US FDA issued an early alert for the Watchman access systems.
A late-August batch of device classifications from the US FDA includes genetic tests from 23andMe, hand-held spinal surgery tools, and several IVDs.
Amendments to Germany’s – barely in force – health reform law will be decided after the summer break. The new DRGs payments plan and service groups will be reviewed, but critics fear for the law’s future.
