The casual observer may be inclined to think that the European Union’s Medical Device Regulation (MDR) is off to a rocky start, but those whose livelihoods are at stake have a more intimate view of the situation. An attendee at a Sept. 12 session at this year’s Regulatory Convergence lamented what she believes is a dismal outlook for EU patients and device makers in the coming year, a testimonial that drew cheers and applause from those in attendance.

Medical science has been experimenting with smart devices for several years to determine whether these products can detect circulatory system diseases, and a study presented at the 2022 meeting of the European Society of Cardiology (ESC 2022) seems to strongly suggest that the answer is a resounding yes. The eBRAVE-AF study of more than 5,500 enrollees of middle age or older demonstrated the ability of a smartphone camera and a downloadable app to at beat conventional screening for atrial fibrillation (AF), a finding that could save lives and boost the prospects of device makers in the digital health space.

Payers are known to have a significant burden in crafting coverage and reimbursement policies for in vitro diagnostics, but Gillian Hooker, chief scientific officer at Concert Genetics Inc., of Nashville, Tenn., told an audience at the Next Generation DX Summit that the dilemma may be more expensive than commonly appreciated. Hooker said administrative costs may add as much as $125 per administered test, an artifact of a fragmented value chain that seems to enjoy few, if any prospects of improvement in the near term.