Organogenesis' Apligraf living skin construct reduces the time it takes diabetic foot ulcers to heal by almost one-third, the company says.
Join thousands of industry professionals who rely on Medtech Insight for daily insights
Already a subscriber?
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.
