FDA approves Medtronic for home capsule endoscopy

“I think this is a great example of [moving care outside of the clinical setting] looks like this, ”Matthews said. Ideally, an endoscopy at home would speed up the time to diagnosis – and therefore the time to treatment – since doctors may not have to wait that long to make an appointment or get the datalogger back from the hospital. a patient.

Digital tablets have become a topic of interest in healthcare in recent years, although there are only a few products on the market. Much of the discussion has focused on digital pills used to track adherence to treatment, one expert said. report published by Rand Corp. In the past year. The FDA also said last year that it would temporarily authorize another medical device company, CapsoVision, to sell its capsule endoscopy procedure to patients at home during the pandemic.

Digital tablets “are very much in line with the trend towards expanding remote sensing capabilities,” said Benjamin Boudreau, a policy researcher at Rand Corp. who co-authored the report. The report, on the so-called Internet of Bodies, predicts a future in which activity trackers, internet-connected clothing and other sensors will allow doctors to better understand what is going on in the patient’s body in order to personalize care.

Johns Hopkins Medicine’s Matthews said he will be monitoring data on the safety and effectiveness of home endoscopy products to make sure the remote procedure does not have unintended consequences.

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

Medtronic’s Home Endoscopy Program is currently FDA-cleared for lesions that may indicate problems such as Crohn’s disease or unclear bleeding. Medtronic plans to provide data to the FDA for other indications such as colon imaging, Di Napoli said.

The company shared its ambitious plans for a home endoscopy system.

At Medtronic Investor Day last year Di Napoli announced partnership with Amazon use the company’s artificial intelligence and cloud-based tools so that the capsule can automatically analyze the patient’s gastrointestinal images and upload the images directly to the cloud, without an external data logger.

So far, home endoscopy “is a smaller area for Medtronic,” says Ryan Zimmerman, a medical technology analyst at BTIG. But “this is clearly a huge market,” he said, noting that millions of people undergo colonoscopy and other colon cancer screening every year.

Medtronic’s respiratory, gastrointestinal and renal systems revenue in the last quarter was $ 768 million, up 6.7% year-on-year and 9.6% of the company’s $ 8 billion total quarterly revenue. …

The company is still figuring out pricing and cost recovery details for the new home endoscopy program, Di Napoli said. The cost of a home procedure is similar to standard capsule endoscopy, as providers can bill for capsule endoscopy and telemedicine visits. The program is not intended to replace upper or lower endoscopy.

According to Di Napoli, the main added value of home capsule endoscopy is the shipping and handling of equipment that Medtronic covered during its early pilot projects.

Bass currently offers home capsule endoscopy to his patients. Bass said he has performed home capsule endoscopy on about two dozen patients since December.

In some cases, for example, if the patient has trouble swallowing, dementia, or another problem that makes it difficult at home, he asks them to come to the office. If the patient is uncomfortable with performing the procedure at home, he will also provide him with this opportunity. But most prefer the convenience of not having to take a day off to travel to the office.

Bass believes the COVID-19 pandemic has pushed healthcare to innovate and change processes faster. He said he hopes the industry will remain open-minded about finding new ways to reschedule medical care traditionally provided to patients at home, including the use of digital pills to identify problems that extend beyond the small intestine.

“We are slowly changing the way we do things,” Bass said. “If it weren’t for COVID here, I don’t think we would have done much differently.”

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