The SOFTWARE Act, introduced in the House by Rep. Marsha Blackburn, R-Tenn., with support from House members on both sides of the aisle, attempts to redefine regulation of health information technology, and, in particular, limit FDA’s oversight to “products that pose a potential risk to human health.”
Rep. Marsha Blackburn, R-Tenn., and a bipartisan group of colleagues in the House introduced the SOFTWARE Act Oct. 22 to redefine the regulation of health information technology, with the probable effect of deregulating much of the sector.
Besides Blackburn, the bill is cosponsored by Reps. Gene Green, D-Texas, Phil Gingrey, R-Ga., Diana DeGette, D-Colo., Greg Walden, R-Ore., and G.K. Butterfield, D-N.C.
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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.
During MD&M East last week, regulatory consultant Darren Reeves reminded device manufacturers that the time to get ready to comply with the new Quality Management System Regulation is now.
Handheld diagnostics are more powerful, accessible and clinically relevant than ever. Medtech Insight spoke to companies behind such technologies to learn how they work and discuss their commercial models.
An interactive look at recent executive-level company changes and promotions in the medical device and diagnostics industries.
