FDA approves Medtronic’s home capsule endoscopy procedure


“I think this is a good example [moving care outside of the clinical setting] It looks like,” Matthews said. Ideally, home endoscopy can speed up diagnosis time—and subsequently, treatment time—because doctors may not have to wait long to schedule patient appointments or retrieve data records from the hospital The patient.

In recent years, digital pills have been a hot area in the healthcare sector, even though there are only a few products on the market.Most of the discussion focused on the digital pill used to track medication adherence, according to report The RAND company published it last year. The US Food and Drug Administration also said last year that it will temporarily allow another medical device company, CapsoVision, to sell its capsule endoscopy procedures to patients at home during the pandemic.

Benjamin Boudreaux, a co-author of the report and a policy researcher at the RAND Corporation, said that the digital pill “is very much in line with the trend of increasing remote sensing capabilities.” This report on the so-called “Internet of the Body” predicts the future. Activity trackers, networked clothing and other sensors can allow doctors to better understand what is happening on the patient’s body, thereby enabling personalized care.

Matthews of Johns Hopkins School of Medicine said that he will pay close attention to the safety and effectiveness data of home endoscope products to ensure that remote surgery will not have any unintended consequences.

But in the end, home endoscopy “represents an important step forward in providing more patient-centered care,” he said. “This is a good sign… where is medicine going.”

So far, Medtronic’s home endoscopy program has been approved by the FDA to detect lesions that may indicate problems such as Crohn’s disease or unknown bleeding. According to Di Napoli, Medtronic is planning to submit data for other indications to the F???da, such as visualization of the colon.

The company shared its ambitious plans for home endoscope systems.

At Medtronic’s Investor Day last year, Di Naples Announced cooperation with Amazon Using the company’s artificial intelligence and cloud tools, the capsule can automatically analyze the images of the patient’s gastrointestinal tract and upload the images directly to the cloud without the need for external data loggers.

Ryan Zimmerman, an analyst in charge of medical technology at BTIG, said that so far, home endoscopes are “a smaller area for Medtronic.” But “obviously, this is a huge market,” he said, noting that millions of people receive colonoscopy and other colon cancer screenings every year.

Medtronic’s respiratory, gastrointestinal, and kidney revenues in the most recent quarter were US$768 million, a year-on-year increase of 6.7%, and accounted for 9.6% of the company’s total quarterly revenue of US$8.0 billion.

Di Napoli said the company is still working on pricing and reimbursement details for the new home endoscopy program. The cost of home surgery is similar to a standard capsule endoscopy, because the provider can charge for capsule endoscopy and telemedicine visits. This procedure is not suitable for replacing upper or lower endoscopy.

Di Napoli said that the main added cost of home capsule endoscopes is the transportation and delivery of the equipment-which Medtronic covered during the initial pilot.

At home is now the standard way for Bass to provide capsule endoscopy to its patients. Buss said that since December last year, he has performed capsule endoscopy on approximately 22 patients at home.

In some cases, such as if the patient has difficulty swallowing or suffers from dementia or other problems that will make the choice at home challenging, he will ask them to enter the office. If the patient is uncomfortable undergoing surgery at home, he will also give them that choice. But most people prefer the convenience of not having to take a day off to go to the office.

Bass attributes the COVID-19 pandemic to Promote healthcare innovation And modify the process faster. He said he hopes to see the industry continue to maintain an open mind, looking for new ways to transfer the care that has traditionally been done in person to patients at home-including the use of digital tablets to identify problems outside the small intestine.

As a field, “we have been slowly changing the way we do things,” Bass said. “Without COVID, I don’t think we would do many different things.”





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