Apple Executives Met With FDA to Discuss Mobile Medical Applications

Apple has signaled strong interest in health-monitoring technology, which could wind up in a widely anticipated smartwatch. A group of senior Apple executives met with directors at the United States Food and Drug Administration in December to discuss mobile medical applications, according to the FDA’s public calendars that list participants of meetings.

Among the participants from Apple were Jeff Williams, senior vice president of operations; Bud Tribble, vice president of software technology at Apple; Michael O’Reilly, the former chief medical officer of Masimo Corporation, who joined Apple in 2013; and an employee from Apple’s government affairs department. On the FDA side of the table were Jeff Shuren, the director of the agency’s Center for Devices and Radiological Health, and Bakul Patel, who drafted the FDA’s mobile medical app guidance and is a staunch advocate for patient safety when it comes to apps and medical gadgets. It is widely expected that the watch will have a focus on health monitoring. Apple last year hired several people with expertise in medical sensors, including O’Reilly. His former company, Masimo makes medical monitoring devices. Bob Mansfield, Apple’s senior vice president for technologies, who previously ran hardware engineering, has been heavily involved in exploring devices and sensors and technologies within Apple that can monitor people’s health and connect to an iPhone, according to an Apple employee who is not authorized to speak publicly for the company. Mansfield is directly involved in the Apple smartwatch hardware, this person said.