The Health Care Financing Administration intends to allow Medicare coverage "of routine care costs" for all device trials conducted under IDEs, provided they fall within statutory benefits, according to the agency.
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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 company reaffirmed its guidance for adjusted gross profit margin for the full year 2025 to remain within the original range of 78% to 79%. Chief financial officer Scott Ullem attributed this to currency and tariff dynamics.
Olympus and Revival Healthcare Capital have launched Swan Endosurgical in a $458m milestone-based joint venture to develop a robotic platform for endoluminal surgery. The deal combines Olympus’ GI expertise with Revival’s start-up model, but will face technical and regulatory hurdles.
The biotech funding landscape is undergoing a fundamental shift. With traditional VC becoming increasingly cautious and selective, industry executives are exploring new avenues for capital. Conversely, this evolution may ultimately benefit the sector's long-term sustainability.
