The ECG feature is one of the main highlights of the Apple Watch Series 4, but as it turns out, bringing it to the market is quite a challenge for Apple.
Not only that the company received the FDA approval in the United States literally just a few hours before the September 12 press unveiling, but Apple also needs substantially more time to roll it out in other countries, mostly because of the clearance it must receive in each country.
The United Kingdom is one such example, and a report from 9to5mac revealed that it could take many months before Apple can get ECG ready for the local market.
First and foremost, the Medicines and Healthcare products Regulatory Agency (MHRA) requires companies launching such devices to perform a clinical investigation before the public release, and a pre-study notification is required.
“You may need to carry out a clinical investigation as part of the process… (read more)
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