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A High-Tech Day for the FDA Emphasizes Its Digital Shift


Two mHealth approvals provide a snapshot of the agency’s evolution.

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Not long ago, the U.S. Food and Drug Administration had a reputation of being behind, or even resistant to, the technological innovations that promised to improve healthcare. In 2012, a story in the Washington Post detailed one tech company’s multiyear, budget-busting fight to earn approval for a medical imaging app—the sort of program that is common today. But back then, similar clashes between the FDA and digital-health developers were the norm.

How things have changed. That same Washington Post article described the seeds that helped regulators and innovators begin to understand where they stood and, ultimately, how to change a process that had come to hamper healthcare’s high-tech revolution. Since then, FDA Commissioner Scott Gottlieb, MD, has further prioritized digital health, exploring fast lanes for software companies, launching data-driven initiatives, and calling on Silicon Valley to fight the opioid crisis.

>> READ: How Might the FDA’s New Pilot Program Transform Digital Health?

“As part of our mission, we must also take steps to make sure that beneficial new technologies can efficiently advance and be made available to patients in a timely way,” Gottlieb said in April. “This is ultimately how patients are going to benefit from science.”

Just yesterday, two health-tech companies released two news briefs that further supported the idea that Gottlieb’s FDA is making strides in its mission to become more tech-friendly. By the morning’s end, the Swiss tech company Oculocare Medical and San Diego-based Companion Medical each announced approvals for their separate mobile health (mHealth) technologies.

The products were exactly the kind of thing that would have met great resistance, at great cost and delays going to market, from the FDA of old.

Oculocare’s Alleye is an mHealth app designed to monitor the eye and detect macular degeneration in certain patients, including those with diabetic retinopathy. After receiving a diagnosis, patients may take their own measurements via smartphones or tablets, which then transfer the data to physicians, who analyze the results. Europe approved the software last year.

Companion Medical’s InPen app for Android, which works with a smart pen to improve diabetes care, also got the green light from the FDA, following the agency’s approval of its iOS companion last December. The technology package contains a dose calculator, insulin tracking, dose reminders, and more, all the while transmitting data to a patient’s healthcare provider.

Once upon a time, it would have been unlikely to hear of two mHealth approvals in a single day. But once upon a time, the FDA was a different agency.

The shift, of course, benefits companies that no longer need to spend as much time or money on complying with overly rigorous, outdated regulations. But the revamped focus is primarily for patients.

“We are very excited about the FDA clearance, which will help millions of patients with [age-related macular degeneration] to better manage their health by monitoring their eyesight,” noted Lucas Bachmann, Oculocare’s CEO and co-founder.

Still, it’s unclear how the FDA’s digital push will continue to unfold. After all, its leaders and industry partners are still working on the framework for its software precertification program—the initiative that could bring cutting-edge programs, including artificial intelligence systems, to market more quickly—and what it will ultimately look like. But one thing is clear: The FDA’s no longer holding on to the past.

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