Firm's second generation iUni unicompartmental knee resurfacing system is the only such device on the market with patient-specific jig instrumentation, which reduces the number of surgical steps during knee replacement, according to ConforMIS VP, Engineering John Slamin. The second-generation system, which launched last month after receiving 510(k) clearance, also features an improved design that reduces wear and iView patient-specific planning images that improve visualization for surgeons. The first-generation iUni launched in early 2008. ConforMIS also is preparing to file a 510(k) for its iTotal tri-compartmental knee resurfacing system (1"The Gray Sheet" July 13, 2009)
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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.
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.
Research recently published in JAMA Internal Medicine found that the FDA met its review timeline goals for the majority of breakthrough devices – but also revealed some apparent shortcomings in safety data supporting the submissions.
