Health Care

FDA clears at-home capsule endoscopy procedure from Medtronic

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“I think this is a great example of what [moving care outside of the clinical setting] looks like,” Mathews said. Ideally, at-home endoscopy could speed time to diagnosis—and subsequently, time to treatment—since physicians might not have to wait as long to schedule patients for an appointment or to get a data recorder back from the patient.

Digital pills have been an area of interest in healthcare in recent years, though there’s only a handful of products on the market. Much of the discussion has centered on digital pills used to track medication adherence, according to a report published by Rand Corp. last year. The FDA last year also said it would temporarily allow another medical device company, CapsoVision, to sell its capsule endoscopy procedure to patients at home during the pandemic.

Digital pills are “very much in line with the trend toward greater remote sensing capabilities,” said Benjamin Boudreaux, a policy researcher at Rand Corp. who co-authored the report. The report, on the so-called “internet of bodies,” forecasts a future where activity trackers, internet-connected clothing and other sensors let doctors better understand what’s happening in a patient’s body to personalize care.

Mathews at Johns Hopkins Medicine said he’ll be watching safety and efficacy data from at-home endoscopy products to make sure there aren’t any unanticipated consequences of a remote procedure.

But ultimately, at-home endoscopy “represents a meaningful step forward in delivering more patient-centered care,” he said. “This is a great signal of … where medicine is heading.”

So far, the at-home endoscopy program from Medtronic is cleared by the FDA for detecting lesions that could indicate problems like Crohn’s disease or obscure bleeding. Medtronic is planning to submit data to the FDA for other indications, like visualization of the colon, too, according to Di Napoli.

The company has shared ambitious plans for its at-home endoscopy system.

At Medtronic’s investor day last year, Di Napoli announced a partnership with Amazon to leverage the company’s artificial intelligence and cloud tools, so that the capsule could automatically analyze images of a patient’s gastrointestinal tract and upload images directly to the cloud, without an external data recorder.

So far, at-home endoscopy “is a smaller area for Medtronic,” said Ryan Zimmerman, an analyst at BTIG who covers medical technology. But “clearly, it’s a huge market,” he said, noting that millions of people undergo colonoscopy and other colon cancer screenings each year.

Medtronic posted $768 million in revenue for its respiratory, gastrointestinal and renal division for its most recent quarter, up 6.7% year-over-year and representing 9.6% of the company’s total $8 billion in quarterly revenue.

The company is still figuring out pricing and reimbursement details for the new at-home endoscopy program, according to Di Napoli. The cost for the at-home procedure is similar to standard capsule endoscopy, since providers can bill for capsule endoscopy and telehealth visits. The program isn’t indicated to replace upper or lower endoscopy.

The main added cost of at-home capsule endoscopy is shipping and delivering the equipment—which Medtronic covered during the initial pilots, Di Napoli said.

At-home is now the standard way that Bass offers capsule endoscopy to his patients. Bass said he’s performed at-home capsule endoscopy with about two dozen patients since December.

In some cases, like if a patient has trouble swallowing or has dementia or another issue that would make the at-home option challenging, he’ll ask them to come into the office. If a patient isn’t comfortable doing the procedure at home, he’ll give them that option, too. But most prefer the convenience of not having to take a day off of work to travel to the office.

Bass credits the COVID-19 pandemic with pushing healthcare to innovate and modify processes more quickly. He said he hopes to see the industry continue to keep an open mind about figuring out new ways to move care that’s traditionally been done in person to patients at home—including using digital pills to identify issues beyond the small bowel.

As a field, “we’ve been slow to change how we do things,” Bass said. “If COVID wasn’t here, I don’t think we would have been doing a lot of things differently.”

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