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Home / Apple / Apple VP of Health says the FDA was "very critical" in the Apple Watch clearance, the relationship with the agency is "good"

Apple VP of Health says the FDA was "very critical" in the Apple Watch clearance, the relationship with the agency is "good"



In an interview published Friday, Apple's health professor Dr. Sumbul Desai discussed the company's newborn interest in health and medicine, and suggests products such as the Apple Watch Series 4 and Health App are stepping stones to more advanced devices and services.

  Desai

Apple Health Professor Dr. Sumbul Desai. | Source: MobiHealthNews

Speaking to MobiHealthNews Desai said the first answer to Apple's first advance to devices removed by the US Food Drug Administration ̵

1; Apple Watch Series 4 – I've heard some cardiologists say, Yep, I started getting ECGs sent to me right away, Desai said. "And it has been" pretty decent ", with doctors already receiving action data from Watch's ECG function.

their biggest frustration is not around so much to get the ECG because they have found it useful, but it is that the healthcare system still has Finding the Right Way to Deal With That Incoming. "

Apple is trying to solve medical data management – what Desai calls a democratization of data – through applications and services such as health recordings. Traditi Unfortunately, patient health information is stored in archives maintained by health mail companies, but Apple's goal is to make the data portable. The company has also built direct sharing capabilities into its software, including PDF export for data generated by the ECG app for Apple Watch.

The latest Watch model is the first of Apple's devices to receive clearance from the FDA. COO Jeff Williams told the performance during a launch event last September, saying that Watch is "the first ECG product offered over the counter directly to consumers."

Desai offered background on the certification process in the interview and noted that Apple has developed a relationship with the FDA after working with the agency for years on various projects.

"So we have a good relationship with the FDA," Desai said. "But they kept us busy. I think they asked us very difficult questions, and in light of the size and impact we had, were very critical of our products and made us do the right thing and think about the user First and customer safety. first – as they should. "

When Apple recently pushed its toe into the health of health technology, Desai said the FDA helped the company navigate rigorous regulatory processes.

She tells of customer expressions that promise Watch's ability to identify atrial fibrillation and other irregular heart rhythms. Some of these stories have made the news, including a recent case where Watch's ECG data helped with the discovery of AFib in a Seattle man being monitored for the condition.

Desai touches on other Apple Watch related topics, including demographic targeting. Some have seen Watch's new ECG and autumn detection features most beneficial to older users, but Desai rejects these claims. Falls, she said, are one of the most common causes of contingency visits of all ages, while studies currently consider the prevalence of AFib in younger patients.

While she refused to comment on future products, Desai said Apple is in the "first inning" of its entry into health technology. More products such as Apple Watch seem to be in the pipeline, but it can be Apple's commitment to health data retention and deployment, where the company is making its mark on the industry.

"What drives us hears from our customers that we have had an impact on their health, and we have really moved toward thinking about how we democratize data, health and education, and truly democratize being good for everyone, " she said.

Desai joined Apple in 2017 after being CEO of Stanford Center for Digital Health, Vice President of Strategy and Innovation at Stanford Medical and Medical Director of Digital Strategy and Innovation at Stanford Healthcare.


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