Obtaining medical device approval from the FDA is the key to Apple’s healthcare business development ~ Analysts point out

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Jean Manster of Loup Ventures points out that it will be important for Apple’s healthcare business to obtain medical device approval for the device from the Food and Drug Administration (FDA). did.

Is your company’s own primary care maintenance a low priority?

Manster said that the key to Apple’s focus on the healthcare space is to get medical device approval for the device from the FDA.
“Although healthcare-related data collection using Apple products is gaining attention, from a clinician’s point of view, most of the data collected by the Apple Watch is for” entertainment purposes, “” he said. I will.
The Wall Street Journal reports that Apple has an in-house project codenamed “Casper” that has explored the possibility of building Apple’s primary care network.
Casper is still active, but Apple’s potential to build a primary care network is a low priority because it’s outside the company’s core strategy and corporate value. Mr. explains.
Examples of companies that have clinics mainly for employees include the Cook Family Health Center of COOK Medical in the United States and the Fujitsu Clinic in Japan.

FDA approval as a Class II medical device is important

Ultimately, Manster points out that if Apple wants to increase its involvement in the healthcare space, it needs to provide clinicians with more useful data, using the Apple Watch and AirPods series. The healthcare-related data (medical software) measured using it states that it needs to be approved as a Class II medical device.
The “ECG” app has been approved as a Class II medical device, but Apple Watch’s “Blood Oxygen Wellness” is offered as “Wellness, Fun, and Better Life” rather than a medical device. Therefore, the measurement data cannot be used for diagnostic purposes.
Source: Ped 3.0 via iPhone in Canada, Cook Family Health Center, Fujitsu Clinic
Photo: Apple

Source: iPhone Mania

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