“Apple obtained FDA clearance to use the feature in the US just one day before the launch of the Watch, though Apple has not yet enabled it,” Lovejoy reports. “But despite a study suggesting an accuracy rate of 98% in detecting AFib, Apple may face a much tougher battle in gaining similar clearance in the UK.”
“I asked the Medicines and Healthcare products Regulatory Agency (MHRA) what would be involved, and how long the process would typically take,” Lovejoy reports. “The good news is that the process itself isn’t that complicated… However, Apple may also be asked to carry out a ‘clinical investigation’ – or medical study – designed to test the effectiveness of the AFib detection.”
Read more in the full article here.
MacDailyNews Take: Hopefully, Apple has already done the advance work and it won’t take” “years” to get Apple Watch ECG to the UK.