Next Up For Apple: Is a Medical Product Coming in the Future?

November 24, 2015

In a recent interview with The Telegraph, Tim Cook, CEO of Apple®, discussed a variety of topics, including the Apple Watch and the production of a “government-licensed health product,” to name just a few.

According to Cook, the Apple Watch has a number of clear health benefits and is fully equipped with sensors that allow users to monitor their heart rate and activity levels. It has even been given credit for saving the life of a high-school senior. While wearing an Apple Watch, the teenage football player realized that his heart rate was higher than normal. Not long after, the boy mentioned it to his athletic trainer who expressed a great deal of concern and sent him to the doctor immediately. The doctor informed the boy that his organs were basically shutting down and, had he not come in, he could have died the next day.

While this may lead you to believe that Apple could be considering the regulation of the watch, Cook actually stated that he does not want the watch to become a regulated, government-licensed health product. He told The Telegraph that the company does not “want to put the watch through the Food and Drug Administration (FDA) process. I wouldn’t mind putting something adjacent to the watch through it, but not the watch, because it would hold us back from innovating too much, the cycles are too long. But you can begin to envision other things that might be adjacent to it -- maybe an app, maybe something else.”

It will be very interesting to follow Apple as it innovates its watch and potentially releases a medical product of some sort. Only time will tell if that will happen and, if it does, what the product will entail.

Are you in the process of developing a medical product? Do you have a product that needs FDA approval? We can help. Using our proprietary approach, we can help get your product through FDA cheaper, better, and faster. To learn more about our services and how we can help you, contact us today.



Medical Device Agency Alerts

November 24, 2015

FDA Grants Two Mobile Medical Applications to be Used with the Apple Watch

On Tuesday, September 11th, FDA granted two de novo classification requests for mobile medical applications to be used with the Apple Watch. ECG App The first app, referred to as the ECG app,...

Read More
FDA North America

November 24, 2015

General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products Guidance for Industry

Final Guidance July 2022 This guidance is intended to assist sponsors of investigational new drug applications (INDs) and applicants of new drug applications (NDAs), biologics license applications...

Read More
FDA IND

November 24, 2015

FDA releases Guidance for Industry on Bioavailability Studies Submitted in NDAs or INDs — General Considerations

FDA issued a final guidance to drug sponsors on conducting and submitting bioavailability (BA) studies for drug products in investigational new drug applications (INDs), new drug applications (NDAs),...

Read More