The agency approved a total of 91 original PMAs, panel-track PMA supplements and de novo classifications in 2016, outpacing last year's record for approvals of novel devices or indications, according to Medtech Insight's Approvals Tracker. Medtronic topped both the novel device approvals and 510(k) clearance lists for the year. Roche, Abbott, Siemens and GE also showed strong approval and clearance counts.

Q-Med is looking to solve two big problems of the disease management business: creating a proprietary hook and selling cost-benefit results to managed care plans which fit within their very short time horizons. The company believes and has evidence that their coronary artery disease monitor can identify patients who will have a heart attack or require some serious medical intervention within the one-to two year time frame of managed care plans.