Endoscopy saw a rollercoaster year in 2021, with ebbing and flowing waves of COVID-19 and elective surgeries alternately on and off the table — punctuated near year’s end by the discovery of the Omicron variant.
Looking ahead to 2022, artificial intelligence (AI), robotic-assisted endoscopy and reimbursement options are sure to drive endoscopy conversations. Infection prevention will remain a hot topic, and new single-use endoscopes are poised to debut.
The use of artificial intelligence in GI endoscopy moved to the top of the American Society for Gastrointestinal Endoscopy’s Gastrointestinal Endoscopy Editorial Board’s top 10 most significant developments list.
The board considers AI “poised to change endoscopy in the near future” while recognizing that barriers remain for full implementation, particularly cost.
AI and future improvements toward three-dimensional and 4K imaging in robotic endoscopy, as well as novel devices for suturing and dissecting, will spur significant advancements in endoscopic surgery, according to Philip Wai Chiu, a professor at the Chinese University of Hong Kong, Shatin, Hong Kong, in a post in EMJ, an open access e-journal.
“When we talk about AI, we always face the challenge of it being posed as man versus machine; however, I believe that the application of AI should be in collaboration with clinicians and endoscopists,” Chiu writes.
Technology To Handle A Rising Caseload
The CDC predicts the total number of cancer cases in the U.S. will increase by nearly 50 percent by 2050 as a result of population growth and aging. That will create a greater need for new diagnostic technologies in the field of pathology.
“Developments in robotic-assisted endoscopy may provide further options in patients who cannot tolerate conventional endoscopy,” according to research by Dr. Shraddha Gulati and others published in Digestive Endoscopy.
As they write in “The Future of Endoscopy: Advances in Endoscopic Image Innovations,” other developments in optical biopsy make “for an exciting future ahead.” They include “high-resolution spatial imaging using volumetric holographics providing information beyond the superficial mucosa, along with the possibility of functional tissue hypoxia imaging.”
Recasting the Reimbursement Landscape
Reimbursement changes will also impact flexible endoscopy and how it’s practiced.
On July 1, 2020, the Centers for Medicare & Medicaid Services (CMS), the federal agency that administers the Medicare program, created a new transitional pass-through (TPT) category and new HCPCS C code for single-use devices such as the aScope Duodeno, used in performing endoscopic retrograde cholangiopancreatography (ERCP) procedures in the hospital outpatient department. The aScope Duodeno would fall under that code until June 30, 2023.
Hospital outpatient departments may obtain additional, separate payments for devices with transitional pass through, or TPT, status. TPT payment applies to patients with traditional Medicare, but Medicaid, Medicare Advantage and commercial health plans may also recognize the C code and provide separate additional payment. TPT only covers certain procedures.
For instance, beginning Oct. 1, 2021, CMS started providing hospitals with additional device reimbursement for the Ambu Duodeno through NTAP when the device is used in the hospital inpatient setting.
Single-use endoscopes grabbed the spotlight this year as the U.S. Food and Drug Administration (FDA) issued safety communication updates about their use. One recommended a transition to partially or fully disposable duodenoscopes, another to using single-use bronchoscopes when there is increased risk of infection or when treating COVID-19 patients.
Reprocessed urological endoscopes also are under scrutiny as the FDA investigates “numerous” medical device reports describing patient infections and other contamination issues possibly associated with their use.
Endoscopes also won media attention when 45 became the new 50 for colorectal cancer screening due to the rise of colorectal cancer cases among young and middle-aged people.
Colorectal cancer — America’s second-deadliest cancer — is considered a preventable disease because of the effectiveness of early detection and removal of precancerous lesions with colonoscopy. Yet, according to the U.S. Preventive Services Task Force (USPSTF) statement, about a third of adults with access to screening do not take advantage of the option.
The Growing Field of Endoscopy
Juan Jose Gonzalez, CEO of Danish medical device company Ambu A/S, forecasts the single-use endoscopy market will grow from $500 million in 2021 to $2.5 billion by 2025 based on three key catalysts:
Another key trend, according to Gonzalez: All major group purchasing organizations (GPOs) will have single-use endoscopy buying categories by next year, giving U.S. hospitals access to these products. Ambu plans to launch its aScope 5 high-definition scope in 2022, propelling the company into the bronch suite. Ambu plans to bring 20 single-use flexible endoscopy products to market by 2022/23.
Lexington, Mass.-based Fujifilm Medical Systems U.S.A. Inc., has added artificial intelligence, high-tech image capture, and advanced data processing to accelerate innovations in its endoscopy portfolio.
This past year saw the launch of the Olympus EVIS X1, which the company is describing as its most advanced endoscope system to date. It’s designed to improve outcomes from disorders of the stomach, colon and esophagus, along with bronchial diseases.
Boston Scientific reported 11.4 percent organic growth in third quarter net sales for endoscopy, up from $475 million in 2020 to $533 million for the same period in 2021. The company is targeting more than $3 billion in revenue in its endoscopy division in 2025, according to a September Investor Day report.
The global endoscopy devices market is expected to reach nearly $46.7 billion by 2025, according to a report by Endoscopy Devices Global Market 2019. In the U.S. alone, that market is projected to reach $27.9 billion by 2027, according to the U.S. Endoscopy Devices Market Size Forecast 2022-2027.
Growing demand for minimally invasive surgery, new innovations that offer a wider scope of endoscopy applications, and an increase in the obese population who prefer bariatric surgery for weight reduction are among the factors driving growth in the endoscopy market, according to the report.