Summary of Evidence

Wireless Capsule Endoscopy (WCE) is a valuable imaging option for the patients with gastrointestinal disorders. It is a relatively safe procedure that can help, especially for diagnosing small-bowel imaging. For individuals with small-bowel bleeding, Crohn’s disease and small bowel imaging in GI hereditary polyposis syndromes, the evidence includes systematic reviews, randomized controlled trials (RCT), and case series. Relevant outcomes are test validity, symptoms, change in disease status, and other test performance measures. The evidence supports use of WCE for these with low incidence of adverse events. The available evidence is insufficient to support the application of Wireless capsule Endoscopy for other applications. Randomized controlled trials with larger sample sizes are needed to better understand the outcomes and safety of WCE. Similarly, there is insufficient evidence to determine the efficacy and safety of magnetically controlled capsule endoscopy and patency capsule, or health outcomes for individuals with gastrointestinal disorders. Randomized controlled trials with larger sample sizes are needed to understand how these modalities compare with standard of care.

Rationale

The PillCam, previously called M2A® Capsule and Given® Diagnostic System were originally granted 510(k) market clearance by the FDA in August 2001 as an adjunctive method for evaluation of small bowel abnormalities in persons with unexplained or recurrent GI bleeding who have undergone conventional endoscopy and/or other diagnostic procedures that failed to locate the source of bleeding. They received approval in July 2003 as a first-line method for detection of small bowel abnormalities. The Given Diagnostic® System with the PillCam™ ESO was granted 510(k) market clearance in 2004 for visualization of the esophageal mucosa. The PillCam ESO® (Given Imaging, Inc., Duluth, GA) received 510k clearance by the FDA in 2007 for imaging the esophagus. In 2014, the PillCam® COLON 2 (Given Imaging Ltd. [Yoqneam, Israel]) was approved by the FDA as a de novo Class II device. In 2020, the FDA granted de Novo classification for the Navicam®, MCE (Ankon Technologies Co., Ltd., Wuhan, Shanghai, China), a magnetically controlled capsule endoscope. In 2006 the FDA granted 510(k) clearance for the Agile™ Patency System (Given Imaging, Inc., Duluth, GA).

Cortegoso Valdivia P et al (2022) published a systematic review and meta-analysis to evaluate performance measures such as completion, detection and retention rates of Capsule Endoscopy. Literature through to August 2021 was screened for articles regarding all capsule types: small bowel, double-headed capsule for the colon or PillCam®Crohn's capsule, magnetically-controlled capsule endoscopy, esophageal capsule and patency capsule. Primary outcomes included detection rate (DR), completion rate (CR) and capsule retention rate (RR). DR, CR and RR were also analyzed in relation to indications such as obscure GI bleeding (OGIB), known/suspected Crohn's disease (CD), celiac disease (CeD), neoplastic lesions (NL) and clinical symptoms (CS). 328 original articles involving 86,930 patients who underwent CE were included. OGIB was the most common indication (n = 44,750), followed by CS (n = 17,897), CD (n = 11,299), NL (n = 4989) and CeD (n = 947). The most used capsule type was small bowel CE in 236 studies. DR, CR and RR for all indications were 59%, 89.6% and 2%, respectively. According to specific indications: DR were 55%, 66%, 63%, 52% and 62%; CR were 90.6%, 86.5%, 78.2%, 94% and 92.8%; and RR were 2%, 4%, 1%, 6% and 2%.  The authors concluded that pooled DR, CR and RR are acceptable for all capsule types. OGIB is the most common indication for CE. Technological advancements have expanded the scope of CE devices in detecting GI pathology with acceptable rates for a complete examination.

Tamilarasan AG et al (2022) published a systematic review and meta-analysis to evaluate the diagnostic accuracy of PCEs in IBD. The authors comprehensively searched electronic databases (MEDLINE, SCOPUS, EMBASE, and Cochrane Central Register of Controlled Trials) for studies comparing the diagnostic accuracy of PCE with endoscopic evaluation, intestinal ultrasound or magnetic resonance enterography (MRE). Data were analyzed by calculating forest plots and the use of the I2 statistic for heterogeneity. Fourteen studies were identified, with seven studies evaluating PCE diagnostic yield in Crohn's disease (CD) and seven studies in ulcerative colitis (UC). In CD, there was a trend to superiority of PCE over MRE and colonoscopy with a pooled odds ratio (OR) of 1.25 (95% CI, 0.85-1.86%) for the detection of CD. This translated to an increased diagnostic yield of 5% and 7% for PCE compared with MRE and colonoscopy, respectively. PCEs had a diagnostic sensitivity for the detection of UC of 93.8% (95% CI, 87.6-97.0%) and a specificity of 69.8% (95% CI, 38.2-89.6%). The authors concluded that PCEs have a comparable diagnostic yield to colonoscopy and MRE in Crohn's disease. The major difficulty remains standardization of PCE scoring systems and the lack of transmural assessment. In UC, PCE has an excellent diagnostic sensitivity and positive predictive value, but there are limitations to its use including the lack of histologic assessment and poor specificity.

Xiang B et al (2021) published a systematic review and meta-analysis to evaluate the accuracy of fecal calprotectin and capsule endoscopy for the diagnosis of small bowel Crohn's disease and to predict relapse. A systematic literature search was performed for studies to diagnose and predict relapse of the disease with fecal calprotectin and capsule endoscopy. The relevant pooled data including sensitivity, specificity, diagnostic odds ratio, positive likelihood ratio, negative likelihood ratio and area under curve were calculated using Stata 14.0. Twenty-one studies were included in the final analyses. The diagnostic accuracy of the disease and relapse were obtained for capsule endoscopy, with a pooled sensitivity of 0.90 and 0.82, specificity of 0.76 and 0.56, diagnostic odds ratio of 33 and 6, and area under curve of 0.92 and 0.82, respectively. Diagnostic accuracy of the disease was calculated for fecal calprotectin values of 50, 100 and 200 ug/g; the sensitivity values were 0.84, 0.66 and 0.45; specificity values were 0.49, 0.74 and 0.87; diagnostic odds ratio were 5, 5 and 5; and area under curve were 0.74, 0.76 and 0.75, respectively. A fecal calprotectin level of 100-140 ug/g for the prediction of relapse had a pooled sensitivity of 0.68, specificity of 0.91, diagnostic odds ratio of 21, and area under curve of 0.77. The authors concluded that capsule endoscopy is effective in diagnosing small bowel Crohn's disease and predicting relapse.

Wang YC et al (2020) published a systematic review and proportion meta-analysis to determine pooled rates, predictors and temporal-trend of VCE adverse events over the past two decades. Systematic search of PubMed and EMBASE for English-language publications reporting VCE adverse events (January 1, 2000, to March 31, 2019) was performed. Data were extracted independently by two investigators. Pooled VCE adverse event rates were calculated using the random or fixed model as appropriate. Predictors and temporal-trend of each adverse event were performed by meta-regression analyses. In total, 402 studies were identified, including 108,079 VCE procedures. Rate of retention, swallow disorder, aspiration, technical failure, and procedural adverse events were 0.73% (95% confidence interval [CI] 0.59-0.89%), 0.75% (95% CI 0.43-1.13%), 0.00% (95% CI 0.00-0.00%), 0.94% (95% CI 0.65-1.28%), 0.67% (95% CI 0.32-1.10%), respectively; incomplete examination rate of esophagus, stomach, small bowel, and colon were 9.05%, 7.69%, 12.08%, 19.19%, respectively. Patency capsule reduced retention rate by 5.04%, whereas known inflammatory bowel disease increased retention rate by 4.29%. Elder was the risk and protective factor for small bowel incomplete examination (0.30%) and swallow disorder (- 0.72%), respectively. Rates of retention and small bowel incomplete examination significantly declined over time (P = .0006 and P < .0001). The authors believe that VCE adverse event rates were generally low, and retention and small bowel incomplete examination rates declined over the past two decades. Patients with known inflammatory bowel disease or elder should be alerted to high risk of retention or small bowel incomplete examination.

Lei II et al (2024) published a systematic review and meta-analysis aimed at assessing the diagnostic accuracy of CCE for colonic inflammation, predominantly ulcerative colitis (UC) and Crohn's disease (CD). The authors systematically searched electronic databases (EMBASE, MEDLINE, PubMed Central, and Cochrane Library) for studies comparing the diagnostic accuracy between CCE and optical endoscopy as the standard reference. A bivariate random effect model was used for the meta-analysis. From 3797 publications, 23 studies involving 1353 patients were included. Nine studies focused on UC, and ten focused on CD. For UC, CCE showed a pooled sensitivity of 92% (95% CI, 88-95%), a specificity of 71% (95% CI, 35-92%), and an AUC of 0.93 (95% CI, 0.89-0.97). For CD, the pooled sensitivity was 92% (95% CI, 89-95%), and the specificity was 88% (95% CI, 84-92%), with an AUC of 0.87 (95% CI, 0.76-0.98). Overall, for inflammatory bowel disease, the pooled sensitivity, specificity, and AUC were 90% (95% CI, 85-93%), 76% (95% CI, 56-90%), and 0.92 (95% CI, 0.94-0.97), respectively. The authors concluded that despite the challenges around standardized disease scoring and the lack of histological confirmation, CCE performs well in diagnosing inflammatory bowel disease, It demonstrates high sensitivity in both UC and Crohn's terminal ileitis and colitis and high specificity in Crohn's disease. Further studies are needed to evaluate the diagnostic accuracy of other colonic inflammatory conditions.

Blanco-Velasco G et al (2021) published a prospective, comparative, randomized, and blinded study to compare the diagnostic yield of the Pillcam SB3 and OMOM CE in small bowel bleeding. Patients with suspected small bowel bleeding were included. All the patients were given both types of CE in random order. Diagnostic yield and functionality between the 2 types of CE were analyzed. 44 patients were included, out of which 54.5% were female with a median age of 63.5 years. Battery time was significantly longer with SB3 (816.5 vs. 700.5 min, p < 0.001), and the download time was shorter with OMOM (33 vs. 132 min, p < 0.001). Both CEs presented 1 failure. The cause of the bleeding was identified in 39 SB3 (88.6%) and in 34 OMOM CE (77.3%) (p = 0.256). P2 lesions were observed in 32 SB3 (72.7%) and in 29 OMOM CE (65.9%) (p = 0.784). The agreement between both CEs for P2 lesions was moderate (κ = 0.628). The study concluded that Pillcam SB3 and OMOM devices are safe procedures and have a similar diagnostic yield. Significant differences were observed in the battery life and download time with both CEs.

Branchi F et al (2020) published a prospective randomized trial aimed at evaluating the diagnostic yield and efficacy of the lateral/panoramic versus the axial view capsule system in CD. Consecutive CD patients were enrolled in a prospective monocentric study. Each patient ingested an axial (PillCam SB3) and a lateral/panoramic (CapsoCam Plus) view capsule with a 3-h interval in a randomized order. Two experts blindly evaluated the CE carried out. A third expert reviewed the videos in cases of discordance. Twenty-five CD patients were enrolled (four males, age at CE 51.2 ± 16.6 years, age at CD diagnosis 41.7 ± 20.6, years on a gluten-free diet [GFD] 9.6 ± 9.4). Indications at CE were refractory CD in nine cases, non-responsiveness to GFD in 10 and GFD non-compliance in six. A positive finding was evidenced in 15 (60%) and 13 (52%) cases by CapsoCam and PillCam respectively (not significant). Atrophy was detected by both capsules. Considering the percentage of the small-bowel mucosa presenting atrophy signs, mean values were 22% ± 35 and 20% ± 29 for lateral/panoramic and axial systems, respectively (not significant). Compared to duodenal histology, PillCam correctly identified 80% of patients with SB atrophy, whereas CapsoCam identified 73% of cases. The authors concluded that lateral/panoramic view CE is effective in the detection of small-bowel atrophy in CD and presents good sensitivity and specificity when compared to histology.

Rubin et al (2011) published a pilot study evaluating the ability of Live View Video Capsule Endoscopy (VCE) with Pillcam Eso(®) to accurately identify high and low risk patients with UGIB. Twenty-four patients with a history of UGIB within 48 h of admission to the ER were randomized to VCE versus standard clinical assessment. VCE was read real-time at the bedside and later reviewed after download. Positive VCE findings included coffee grounds, blood clot, red blood, or a bleeding lesion. VCE positive patients underwent EGD within 6 h. Control patients and VCE negative patients underwent EGD within 24 h. Seven of 12 patients were VCE positive. All seven had confirmatory stigmata at EGD. Of the five VCE negative patients, four had no stigmata at EGD and one was not endoscoped due to comorbidities. The actual lesion was visualized at VCE in four of 12 patients during live view and in an additional two patients after download (6/12). Time to endoscopy in the VCE positive group was significantly shorter than control patients (2.5 vs. 8.9 h, P = 0.029). There was no mortality. Blood transfusion requirement and length of stay were not significantly different in the two groups. The study concluded that Live view VCE accurately identifies high and low risk ER patients with UGIB. Use of VCE to risk stratify these patients significantly reduced time to emergent EGD and therapeutic intervention.

Hussey et al (2018) published an observational, prospective, single-center study of CCE post-incomplete colonoscopies. The aim was to prospectively assess the efficacy of same-day CCE after incomplete OC in an unselected patient cohort. Patients with an incomplete OC for any reason other than obstruction or inadequate bowel preparation were recruited. CCE was performed after a minimum of a one-hour fast. Once the patient was fully alert, intravenous metoclopramide was administered after capsule ingestion when possible, and a standard CCE booster protocol was then followed. Relevant clinical information was recorded. CCE completion rates, findings and their impact, and adverse events were noted. Fifty patients were recruited, mean age = 57 years and 66% (n = 32) were female. Seventy-six per cent (n = 38) of CCEs were complete; however, full colonic views were obtained in 84% (n = 42) of cases. Patients > 50 years of age were five times more likely to have an incomplete CCE and there was also a trend towards known comorbidities associated with hypomobility having reduced excretion rates. Overall diagnostic yield for CCE in the unexplored segments was 74% (n = 37), with 26% (n = 13) of patients requiring significant changes in management based on CCE findings. The overall incremental yield was 38%. CCE findings were normal 26% (n = 13), polyps 38% (n = 19), inflammation 22% (n = 11), diverticular disease 25 (n = 12), angiodysplasia 3% (n = 1) and cancer 3% (n = 1). Significant small bowel findings were found in three (6%) cases, including Crohn's disease and a neuroendocrine tumor. A major adverse event occurred in one patient (2%), related to capsule retention. The authors concluded that same-day CCE is a viable alternative means to assess unexplored segments of the colon after incomplete OC in selected patients.

Eliakim et al (2020) published a sub-study of a prospective randomized controlled Comprehensive Individualized proactive therapy of Crohn's Disease trial (CURE-CD) which aimed to compare the correlation and reliability of the novel PillCam Crohn's score with the existing small bowel capsule Lewis inflammatory score. The study cohort included Crohn's disease patients in remission who were evaluated with PillCam Crohn's. Each result was independently reviewed by two experienced readers. Inflammation was scored in all studies using Lewis inflammatory score and PillCam Crohn's score (comprised of a sum of scores for most common and most severe lesions multiplied by percentage of segmental involvement + stricture score). Fifty-four PillCam Crohn's studies from 41 patients were included. The median Lewis inflammatory score was 225 for both readers. The median PillCam Crohn's score was six (0-14) and four (3-15) for readers 1 and 2, respectively. There was a high inter-rater reliability coefficient between the two readers for Lewis inflammatory and PillCam Crohn's score (0.9, p < 0.0001 for both). The correlation between PillCam Crohn's score and fecal calprotectin was stronger than for Lewis inflammatory score (r = 0.32 and 0.54 respectively, p = 0.001 for both). The authors believe that the novel panenteric capsule score correlates well with the Lewis inflammatory score, has excellent reliability, and may be potentially more accurate in estimation of the panenteric inflammatory burden.

Keller et al (2010) published a randomized, clinical trial in healthy volunteers assessing the safety and efficacy of remote magnetic manipulation of a modified capsule endoscope (magnetic maneuverable capsule [MMC]; Given Imaging Ltd, Yoqneam, Israel) in the esophagus of healthy humans. This study involved 10 healthy volunteers and was conducted in an academic hospital setting. All participants swallowed a conventional capsule (ESO2; Given Imaging) and a capsule endoscope with magnetic material, the MMC, which is activated by a thermal switch, in random order (1 week apart). An external magnetic paddle (EMP; Given Imaging) was used to manipulate the MMC within the esophageal lumen. MMC responsiveness was evaluated on a screen showing the MMC film in real time. The main outcome measures were safety and tolerability of the procedure (questionnaire), responsiveness of the MMC to the EMP, esophageal transit time, and visualization of the Z-line. No adverse events occurred apart from mild retrosternal pressure (n = 5). The ability to rotate the MMC around its longitudinal axis and to tilt it by defined movements of the EMP was clearly demonstrated in 9 volunteers. Esophageal transit time was highly variable for both capsules (MMC, 111-1514 seconds; ESO2, 47-1474 seconds), but the MMC stayed longer in the esophagus in 8 participants (P < .01). Visualization of the Z-line was more efficient with the ESO2 (inspection of 73% ± 18% of the circumference vs 33% ± 27%, P = .01). The magnetic forces were not strong enough to hold the MMC against peristalsis when the capsule approached the gastroesophageal junction. The authors had difficulty reproducing the tumbling movements of the capsule within the esophagus consistently. The study was also limited by smaller sample size and lack of follow-up.

The American Society of Gastrointestinal Endoscopy (ASGE) in their 2013 technology status evaluation report on Wireless Capsule Endoscopy stated that, WCE has established itself as a valuable test for imaging the small intestine. It is a safe and relatively easy procedure to perform that can provide valuable information in the diagnosis of small-bowel conditions. Its applications still remain limited within the esophagus and colon. Future developments may include improving visualization within the esophagus and developing technologies that may allow manipulation of the capsule within the GI tract and biopsy capabilities. In general, WCE is a safe procedure. The main potential adverse event of WCE is capsule retention, defined as a capsule endoscope remaining in the digestive tract for a minimum of 2 weeks or one that has required directed therapy to aid its passage. Retention can occur in the setting of NSAID strictures, Crohn’s disease, small-bowel tumors, radiation enteritis, and surgical anastomotic strictures. Occasional cases of retention within other sites (e.g., Zenker’s diverticulum, duodenal diverticulum, umbilical hernia, Meckel’s diverticulum) have been reported. An abdominal radiograph is recommended after 2 weeks if retention is suspected and if confirmed, may require surgery or endoscopic intervention. In their 2022 guidelines on Quality Indicators for Capsule Endoscopy and Deep Enteroscopy, the ASGE state that, substantial evidence and expert consensus exist to support the use of capsule endoscopy as a diagnostic tool in individuals with overt and occult suspected small bowel bleeding including iron-deficiency anemia.

American College of Gastroenterology (ACG) in their 2015 practice guidelines on the diagnosis and management of small bowel bleeding, recommend, based on moderate level evidence that Video Capsule Endoscopy (VCE) should be considered as a first-line procedure for small bowel (SB) evaluation after upper and lower GI sources have been excluded, including second-look endoscopy when indicated. In the diagnosis of small bowel bleeding, provided that the VCE in not contraindicated, it should be performed before deep enteroscopy to increase diagnostic yield.

Reference List

1. Cortegoso Valdivia P, Skonieczna-Żydecka K, Elosua A, et al. Indications, Detection, Completion and Retention Rates of Capsule Endoscopy in Two Decades of Use: A Systematic Review and Meta-Analysis. Diagnostics (Basel). 2022;12(5):1105. Published 2022 Apr 28. doi:10.3390/diagnostics12051105
2. Tamilarasan AG, Tran Y, Paramsothy S, Leong R. The diagnostic yield of pan-enteric capsule endoscopy in inflammatory bowel disease: A systematic review and meta-analysis. J Gastroenterol Hepatol. 2022;37(12):2207-2216. doi:10.1111/jgh.16007
3. Xiang B, Dong Z, Dai C. The diagnostic and predictive value of fecal calprotectin and capsule endoscopy for small-bowel Crohn's disease: a systematic review and meta-analysis. Rev Esp Enferm Dig. 2021;113(3):193-201. doi:10.17235/reed.2020.6996/2020 
4. Wang YC, Pan J, Liu YW, et al. Adverse events of video capsule endoscopy over the past two decades: a systematic review and proportion meta-analysis. BMC Gastroenterol. 2020;20(1):364. Published 2020 Nov 2. doi:10.1186/s12876-020-01491-w
5. Lei II, Thorndal C, Manzoor MS, et al. The Diagnostic Accuracy of Colon Capsule Endoscopy in Inflammatory Bowel Disease-A Systematic Review and Meta-Analysis. Diagnostics (Basel). 2024;14(18):2056. Published 2024 Sep 16. doi:10.3390/diagnostics14182056 
6. Blanco-Velasco G, Zamarripa-Mottú RA, Solórzano-Pineda OM, Mascarenhas-Saraiva M, Blancas-Valencia JM, Hernández-Mondragón OV. Comparison in the Diagnostic Yield between "Pillcam SB3" Capsule Endoscopy and "OMOM Smart Capsule 2" in Small Bowel Bleeding: A Randomized Head-to-Head Study. Dig Dis. 2021;39(3):211-216. doi:10.1159/000511958
7. Branchi F, Ferretti F, Orlando S, et al. Small-bowel capsule endoscopy in patients with celiac disease, axial versus lateral/panoramic view: Results from a prospective randomized trial. Dig Endosc. 2020;32(5):778-784. doi:10.1111/den.13575 
8. Rubin M, Hussain SA, Shalomov A, Cortes RA, Smith MS, Kim SH. Live view video capsule endoscopy enables risk stratification of patients with acute upper GI bleeding in the emergency room: a pilot study. Dig Dis Sci. 2011;56(3):786-791. doi:10.1007/s10620-010-1336-9
9. Eliakim R, Yablecovitch D, Lahat A, et al. A novel PillCam Crohn's capsule score (Eliakim score) for quantification of mucosal inflammation in Crohn's disease. United European Gastroenterol J. 2020;8(5):544-551. doi:10.1177/2050640620913368 
10. Keller J, Fibbe C, Volke F, et al. Remote magnetic control of a wireless capsule endoscope in the esophagus is safe and feasible: results of a randomized, clinical trial in healthy volunteers. Gastrointest Endosc. 2010;72(5):941-946. doi:10.1016/j.gie.2010.06.053
11. Hussey M, Holleran G, Stack R, Moran N, Tersaruolo C, McNamara D. Same-day colon capsule endoscopy is a viable means to assess unexplored colonic segments after incomplete colonoscopy in selected patients. United European Gastroenterol J. 2018;6(10):1556-1562. doi:10.1177/2050640618800629
12. Lacy BE, Tack J, Gyawali CP. AGA Clinical Practice Update on Management of Medically Refractory Gastroparesis: Expert Review. Clin Gastroenterol Hepatol. 2022;20(3):491-500. doi:10.1016/j.cgh.2021.10.038 
13. ASGE Technology Committee, Wang A, Banerjee S, et al. Wireless capsule endoscopy. Gastrointest Endosc. 2013; 78(6):805-815.
14. Leighton JA, Brock AS, Semrad CE, et al. Quality indicators for capsule endoscopy and deep enteroscopy. Am J Gastroenterol. 2022; 117(11):1780-1796.
15. Gerson LB, Fidler JL, Cave DR, Leighton JA. ACG Clinical Guideline: Diagnosis and Management of Small Bowel Bleeding. Am J Gastroenterol. 2015;110(9):1265-1288. doi:10.1038/ajg.2015.246
16. Food and Drug Administration (FDA) [website]. Searchable 510(k) database scanned for Product Code NEZ (Wireless, gastrointestinal, capsule imaging system). Updated December 6, 2006. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm. Accessed January 7, 2007.
17. Food and Drug Administration (FDA) [website]. 510(k) approvals. K010312. August 1, 2001. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm. Accessed January 7, 2007.
18. Food and Drug Administration (FDA) [website]. 510(k) approvals. K031033. July 1, 2003. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm. Accessed January 7, 2007.
19. Food and Drug Administration (FDA) [website]. 510(k) approvals. K032405. October 29, 2003. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm. Accessed January 7, 2007.
20. U.S. Food and Drug Administration 510(k) Reclassification Order. NaviCam Capsule Endoscope System with NaviCam Stomach Capsule. DEN190037. Silver Spring, MD: FDA. May 22, 2020. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?ID=DEN190037. Accessed on April 01, 2024.
21. U.S. Food and Drug Administration 510(k) Summary. Given PillCam® Platform with PillCam®SB Capsules Given® AGILE Patency System. No. K090557. Silver Spring, MD: FDA. September 28, 2009. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf9/K090557.pdf. Accessed on April 01, 2024.