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ACC Results Recap Part I: Low-Risk TAVR Trials Bring Good News For Edwards And Medtronic; Apple Watch Detects AFib In Apple Heart Study
Medtech Insight's Results Recap is a regular feature covering the major device trial results compiled by MedDeviceTracker. This is the first of three special Results Recaps covering trial data presented at the American College of Cardiology Scientific Sessions in New Orleans, March 16-18, including presentations on Medtronic and Edwards Lifesciences’ transcatheter aortic valves and Apple’s Apple Watch, which now has electrocardiography capabilities.
With a regulatory framework and test plan in place, US FDA says it will use the rest of the year to run experiments in its pre-cert pilot program to figure out what metrics it needs to gather and processes it needs to develop to make the new paradigm for digital health products a reality. The agency says it plans to update stakeholders as needed on its progress.
In 2019, FDA will be taking steps to perform real-world testing of the effectiveness of its pre-cert program for health software and whether the program can be carried out within the agency's current regulatory authorities. The efforts come after more than a year of development and some pushback about statutory overreach and patient safety.
A new hearing aid lets users enjoy the full range of normal hearing frequencies, activated by a contact lens on the eardrum. The hearing aid from Earlens Corp. also provides audio gain without feedback. In October, the company completed an $87m round of financing, which will help launch its next-generation hearing aid, which employs magnetic induction for further hearing refinement.
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