Patient preference evidence was used make regulatory decision making more patient-centered. In addition, we captured the heterogeneity of patient preferences allowing market approval of effective devices for risk tolerant patients. CDRH is using the study tool to define minimum clinical effectiveness to evaluate new weight-loss devices. The methods presented can be applied to a wide variety of medical products. This study supports the ongoing development of a guidance document on incorporating patient preferences into medical-device premarket approval decisions.
Diet and exercise, except in controlled circumstances, have not been shown to provide effective and prolonged weight loss for the majority of those who are obese. Several older drugs intended to reduce weight have been withdrawn from the market, and the new drugs show only modest weight loss. Surgical intervention, specifically procedures that alter the normal gastrointestinal anatomy, does provide prolonged periods of sustained weight loss, with rebound weight gain over time. A variety of medical devices to assist in weight reduction have been studied, but only two are legally marketed devices for obesity. The authors propose a new paradigm for devices intended to treat obesity, based on a benefit-risk determination, with the hope to provide sponsors an a priori tool for systematic assessment of the risks associated with the devices intended for treatment of obesity and to suggest appropriate levels of benefit for devices with different risk levels. The paradigm is not intended to determine the class of a device from a regulatory perspective. This approach was conceived at a Food and Drug Administration (FDA) co-sponsored workshop in October, 2011 and formally presented to an FDA advisory panel for discussion in May 2012.
Artificial intelligence (AI) technologies in clinical medicine have become the subject of intensive investigative efforts and popular attention. In domains ranging from pathology to radiology, AI has demonstrated the potential to improve clinical performance and efficiency. In gastroenterology, AI has been applied on multiple fronts, with particular progress seen in the areas of computer-aided polyp detection (CADe) and computer-aided polyp diagnosis (CADx), to assist gastroenterologists during colonoscopy. As clinical evidence accrues for CADe and CADx, our attention must also turn toward the unique challenges that this new wave of technologies represent for the U.S. Food and Drug Administration and other regulatory agencies, who are tasked with protecting public health by ensuring the safety of medical devices. In this review, we describe the current regulatory pathways for AI tools in gastroenterology and the expected evolution of these pathways. (Gastrointest Endosc 2020;92:801-6.)Artificial intelligence (AI), which refers to computer technology designed to mimic human intelligence, has emerged as a promising tool for tackling a wide variety of challenges in clinical medicine. 1 A subset of AI is machine learning, a technique in which computers use data to perform tasks without explicit instruction. In the last 5 years, numerous applications of AI have been developed and approved for clinical medicine, including identification of diabetic retinopathy and diagnosis of cutaneous malignancy. 2,3 AI technologies have proven especially promising in improving clinical performance during GI endoscopy. Over the past decade, numerous groups have developed novel computer-aided polyp detection (CADe) and computer-aided polyp diagnosis (CADx) systems, using endoscopic still images and video data. [4][5][6][7] In the past 3 years, several prospective clinical trials examining CADx and CADe systems have demonstrated the real-world feasibility of these technologies. In 2018, Mori et al 8 performed a single-center, open-label prospective study examining the performance of a deep learning CADx system, Endobrain, to accurately diagnose diminutive rectosigmoid polyps. The EndoBrain CADx technology subsequently received regulatory approval by the Pharmaceuticals and Medical Devices Agency, a regulatory body in Japan. 9 Soon after, Wang et al 10 published the first randomized clinical trial examining the role of CADe in colonoscopy, which demonstrated a significant increase in adenoma
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