Regulatory News In Brief
Baxter burn treatment gains FDA go-ahead: Baxter plans to launch its Artiss fibrin sealant adhesive for attaching skin grafts onto burn patients at the American Burn Association annual meeting April 29-May 2 in Chicago after receiving biologic license application approval March 19. Artiss is the "first and only" slow-setting fibrin sealant approved for the indication, Baxter notes. Unlike rapid-setting fibrin sealant tissue adhesives, which also contain the blood-clotting proteins fibrinogen and thrombin, Artiss has a lower concentration of thrombin, FDA notes. This allows surgeons more time to position the grafts before adherence to the skin, according to the agency. Intended as an alternative to staples, Artiss also contains aprotinin, a synthetic protein that delays the breakdown of blood clots
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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.
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Medical devices, diagnostics, and equipment face tariffs announced by President Donald Trump, despite industry pleas for exemption. The tariffs, ranging from 10%-49%, impact most countries trading with the US, potentially hindering innovation and increasing costs in the medtech sector.
The US FDA has published its final document to guide sponsors on using sex-specific data in designing clinical trials of medical devices. However, the guidance removes all references to gender that appeared in January’s draft guidance, released before the Trump administration took office.