Apple Needs FDA Approval for its Healthcare Ambitions Says Munster

With Apple CEO Tim Cook claiming that the company’s greatest contribution to mankind will be in health, Loup Ventures analyst Gene Munster has said that FDA approval is the key to Apple’s health ambitions (via Ped 3.0).

So far, some Apple initiatives aimed at broadly disrupting the healthcare sector have struggled to gain traction. “The obstacle for Apple is that from a clinician’s standpoint, the majority of data the Watch collects is primarily for ‘entertainment purposes,” said Munster.

According to a report by The Wall Street Journal, Apple has an internal project codenamed “Casper,” which has explored the possibility of creating an Apple primary care network. 

While Casper is still an active initiative, Munster believes it’s unlikely Apple will ultimately build a primary care network given it is outside of the company’s core competency.

“Instead, we see the company’s health ambitions anchored in devices and data that can be leveraged by clinicians for care. To achieve this, Apple must secure more Class II-grade medical device features for Watch and potentially AirPods. Class II designations give healthcare providers the legal confidence to trust and use the data these devices collect.”

Currently, the Apple Watch has a Class II designation for its atrial fibrillation (Afib) feature granted by the FDA. A Class II designation ensures that collected data is accurate and safe to be acted upon.