CMS will "undertake a complete review of the available literature" on prophylactic implantation of ICDs in patients with poor ventricular function, including SCD-HeFT, DINAMIT, DEFINITE and COMPANION clinical trials, CMS announces March 30. The agency also will assess evidence pertaining to selection of appropriate defibrillators for specific patient populations. The review responds to 1Medtronic's March 18 request that CMS amend its ICD coverage policy to include all patients with at least one year of remaining life expectancy, documented congestive heart failure for greater than 3 months and left-ventricular function of less than 35% - the indication evaluated in the SCD-HeFT trial. Following release of CMS' ICD coverage policy in 2003, the agency agreed to revisit its coverage criteria once SCD-HeFT results were unveiled (2"The Gray Sheet" March 15, 2003, p. 3)...
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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.
While HistoSonics is awaiting the CE mark in Europe, it hit a major milestone by securing early limited market access in Great Britain under a Unmet Clinical Need Authorization (UCNA), bringing its noninvasive histotripsy treatment to patients with liver tumors.
Manufacturing shifts, financial planning, and supply chain changes are among the adjustments that medtech leaders are making to Trump-era tariffs. Medtech Insight’s review of first-quarter earnings calls reveals how firms are navigating the impact and uncertainty of evolving trade policies.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Thirty-six documents have been posted on the tracker since its last update.
