［心律不正撚］覺得新Apple Watch普通嘅你入一入嚟，我話你知佢比你想像中勁好多，將來可能救到好多人

其他你一定要買多件嘢貼響電話or貼響身先會度到ecg 你可以check吓件嘢幾錢

搞笑, 我以為隻watch可以醫好你

小米出隻咁功能既錶睇下你又吹唔吹

如果Apple Watch佢嘅心電感應真係有番咁上下準嘅話


呢個就係重點，係咪真係準確 如果係一定大賣

其實仲可以大力啲按住頸既大動脈

利申：有1×年svt

丫媽都有心律不正，我見好似話有自動報驚功能，好想買隻比佢。

但丫媽唔用iPhone

呢啲錶大家都知係無medical use certified的
病人用的話可以考慮配合FDA 認可醫學用途嘅KardiaBand
咁就更安心了

https://store.alivecor.com/products/kardiaband

咪同S4一樣原理
S4都有FDA認可

係呀
只係想話唔好齋靠隻錶

FDA個database我搵唔到佢個record

kardiaband就有

原來上面討論咗咁多
無追post

https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm558142.htm
2017年

https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm596872.htm
2018年

https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/510kClearances/ucm587897.htm
Kardia Band個clearance

另外search apple都係搵唔到

剩係認可個app?

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm620246.htm?utm_campaign=09122018_Statement_FDA%20Statement

https://www.fda.gov/MedicalDevices/DigitalHealth/DigitalHealthPreCertProgram/default.htm

搵過下apple有參加既FDA program,應該係呢個,Samsung Google都有份

Google既產品 :

多尻餘，你個心真係有問題到出事果陣你自己身體感覺唔到既咩？要用隻手錶提你？

有chest discomfort 咪 check check 囉
做咩咁執著要discover 隱性病
個心有唔妥一定會feel到架啦
要discover 啲隱性病就好心去做詳細screening 啦 唔通靠隻錶做diagnosis 咩
個定位啲連登仔炒晒車

我都好奇怪所以翻查下

原來FDA有個Pilot program 畀digital health software
簡化咗大量程序給予參加者pre-cert
Apple 嘅 Health app 就係通過咗呢個
呢個亦係點解只有app 而非Apple Watch 本身通過認證
而另一方面因為同其他地區嘅審核規格仍有距離
所以暫時未能喺其他巿場用

// Apple has been pushing its Apple Watch to become a more useful device for healthcare, and has worked with the FDA about its ambitions. The company has previously talked to the head of the FDA about "mobile medical applications" in 2014, while in 2017 it was picked to join eight other companies in an FDA pilot program to avoid problematic regulations that could slow down the development of new health-related products. //
https://appleinsider.com/articles/18/09/12/apple-watch-series-4-is-first-consumer-device-to-receive-fda-clearance-for-ecg-monitoring

// Digital Health Software Precertification (Pre-Cert) Program //
https://www.fda.gov/medicaldevices/digitalhealth/digitalhealthprecertprogram/default.htm

做ep好睇醫生手勢

其實510(k)都係類似既野,市面上有類近product就可以做stat comparison唔使做大量clincial tests,咁可以加快產品上架進程

但呢個scheme有個大問題就係有d life long product得2年clinical trial time就上market,跟住好多器材都出左問題,藥物會嚴好多但medical device而家仲係好大漏洞,美國果邊都有d body implant都出事

所以唔好一聽到FDA就出曬水

應該唔係，不過應該都係類似野

巴打你排咗期做手術未？
我要到十二月先見醫生

而家仲一時時有心悸

排咗11月尾

咁都係差唔多
祝巴打做完之後健健康康

按頸(carotid sinus message)有少少risk所以無叫人做
巴打醫好未？