ARTICLE SUMMARY:
In this week’s roundup: AliveCor’s portable six-lead EKG is the first to leverage a new UK National Institute for Health and Care Excellence program for early evaluations of medtech; FDA finally issues its long-awaiting OTC hearing aid regulation; the EU addresses classifications for products without an intended medical purpose; and more from Europe, the US, Australia, and China.
Top Picks
Novel NICE program and OTC hearing aids:
AliveCor EKG leverages new NICE program. The KardiaMobile 6L—a six-lead portable EKG device that links to a smartphone app developed by AliveCor Inc.—is the first to leverage a new medtech program from the UK National Institute for Health and Care Excellence (NICE). An August 12 draft recommendation from NICE conditionally supports use of KardiaMobile 6L in NHS psychiatric services to measure cardiac QT interval for people prescribed antipsychotic medications. The monitoring is needed to inform safe treatment, but in-office 12-lead EKGs can cause reluctance and distress in targeted patients, NICE says. Among the conditions for the draft recommendation: multiple real-world evidence datapoints should be collected. The recommendation is the first to come from NICE’s recently established Early Value Assessment pilot for medtech, which is designed to offer quicker, earlier assessments of promising medtech. The pilot is spearheaded by Mark Chapman, who was tapped in May as NICE’s interim director for Medical Technology and Digital Evaluation after a 21-year career at Medtronic plc. It’s goal is to accelerate access to the devices within the NHS system while more data is collected. When sufficient real-world evidence is generated, NICE will take another look as part of its traditional technology assessment programs. The pilot is primarily, though not exclusively, focused on reviewing promising digital health technologies at the moment. Public comments on the draft KardiaMobile 6L recommendations are due August 25.
