FDA instructed to the company to obtain new clearances for design modifications already made to Renasys. The company says 510(k)s for these changes are pending.
Smith & Nephew PLC announced June 23 that it has temporarily ceased distributing Renasys negative pressure wound therapy products in the U.S. after FDA told the company that it requires 510(k) clearances for modifications the company made to the systems without regulatory approval.
Smith & Nephew said it has already filed 510(k)s with FDA for these modifications, which include enhancements to both Renasys...
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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 European Commission is focusing on how tiny particles behave to help create an EU industrial “powerhouse.”
Under the terms of the new agreement, Philips will also begin bundling essential supplies – including ECG, noninvasive blood pressure (NIBP) components, and batteries – with its Medtronic-enabled monitors.
Bivacor aims to be first to the US market with a permanent total artificial heart, starting with use as a bridge to transplant. CMO William Cohn says data from countries with low transplant rates could support pivotal trials and long-term use.
