Apple recruits human resources who are familiar with medical regulations ~ Is the goal to measure blood sugar in the opple Watch?

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Aim for official FDA approval

Apple is looking for a regulatory project manager, which is required to lead a hardware team in the growing health category and overcome the regulations related to Class II medical equipment. 。 Class II specified by FDA is a group that requires more severe conditions than class II, which is a minimum legal management in a regulation requirements that may be injured in the event of a defect. 。 The detection of arrhythmias mounted on the Apple Watch and the ECG (ECG) function correspond to this class II, but at this stage, the approval was obtained only by obtaining approval (Clearance). There is none. In addition, the blood oxygen concentration measurement function of Apple Watch Series 6 did not require the approval or approval of FDA because it is a "wellness" tool and cannot be diagnosed or treated for illness.

Is the blood sugar measurement function a favorite?

今回のマネージャー募集は、こうした曖昧な部分を明確にし、FDAの規制に対し正面から立ち向かおうとするAppleの方向性を見て取ることができます。Appleによれば、この役職に選ばれた人物は「規制当局の承認を必要とするプロジェクトをリードし、Appleの画期的なテクノロジーの立ち上げに貢献する」とのことで、画期的な技術が今後登場するApple WatchやiPhoneに導入される可能性は高いでしょう。 ニュースサイト9to5Macは、AppleのサプライヤーであるRockleyが最近、手首に装着して血糖値を測定するデジタルヘルスセンサーのシステムを発表したことと関係あるのではないか、と指摘しています。この機能は、今年登場が期待されるApple Watch Series 7には採用が見送られる公算が大きそうですが、そう遠くない将来に実装されることを期待しても良さそうです。Source:9to5Mac,ApplePhoto:YouTube-Apple(kihachi)

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