这个ai可以帮助消灭结肠癌

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Michael Wallace在20年中占胃肠学家的数百种结肠镜检查。他认为他非常擅长认识到可以沿着结肠脊升起的增长,并且可能变成癌症。现在,食品和药物管理局批准了一个新的工具,承诺帮助医生在结肠镜检查期间认识到癌前生长:由Medtronic制作的人工智能系统。医生说,与其他措施一起,该工具可以帮助改善诊断。GI Genius于2019年10月在欧洲批准,是FDA清除的第一个用于帮助检测结直肠息肉的AI。

Michael Wallace在20年中占胃肠学家的数百种结肠镜检查。他认为他非常擅长认识到可以沿着结肠脊升起的增长,并且可能变成癌症。但他并不总是完美的。有时息肉是平坦的,很难看到。其他时候,医生只是想念他们。 “我们都是人类,”Wallace说,他们在梅奥诊所工作。在早上的背靠背手术后需要注意分钟细节,他说,“我们累了。”

如果令人不快,结肠镜检查在突出癌前息肉和预防结肠癌中的高度有效。但该程序的有效性严重依赖于医生执行它的能力。现在,食品和药物管理局批准了一个新的工具,承诺帮助医生在结肠镜检查期间认识到癌前生长:由Medtronic制作的人工智能系统。医生说,与其他措施一起,该工具可以帮助改善诊断。 “我们真的有机会在任何被筛选的人中完全灭绝冒号癌,”华莱士队在该项目上咨询的华莱士说。

Medtronic系统称为Gi Genius,已经看过更多的冒号,而不是大多数医生。 Medtronic和合作伙伴Cosmo Pharmaceutical通过审查欧洲和美国在欧洲和美国在运行毒品试验时收集的康马索收集超过1300万视频来识别息肉。为了“教导”AI来区分潜在的危险生长,将图像用胃肠科学家标记为正常或不健康的组织。然后通过在完美条件下进行的结肠镜阶段开始测试AI逐渐变得更难识别息肉,同样地移动到更加困难的挑战,如区分非常小的息肉,仅在相机范围内短暂地或隐藏一个黑点。

该系统可以添加到医生已经用于执行结肠镜检查的范围内,随着医生探测结肠,突出显示带有绿色盒子的潜在息肉。 GI Genius于2019年10月在欧洲批准,是FDA清除的第一个用于帮助检测结直肠息肉的AI。 “它发现即使是错过的事情,”华莱士说,华莱士曾撰写了对GI Genius的第一个验证研究。 “这是一个令人印象深刻的系统。”

Mark Pochapin,Nyu Langone的胃肠学家没有参与创建GI Genius,说它是有道理的,即AI擅长识别息肉。 “当你看看息肉时,”较少的多样性,“Pochapin说。数百万个结肠镜检查视频提供了充足的数据,以使算法综合。这应该屏蔽系统对其他医疗算法中的偏差的担忧。 “只有这么多品种的息肉,”他说。

Medtronic的GI业务总裁Giovanni di Napoli表示,Medtronic看到Gi Genius和其他AI工具作为未来业务的基石。为此,该公司将更多的时间和资源投入到此设备的FDA批准中。 “我们花了几乎一年的时间来获得FDA批准,”Di Napoli说。 “这是不容易的。”

Medtronic寻求FDA清除,根据该机构称之为De Novo途径,这要求申请人提供有关新设备的安全和有效性的信息,包括临床数据。这是一个冗长,更多的涉及应用程序,即一些其他AI医疗设备避免了。大多数AI和机器学习医疗设备使用被称为510(k)途径的简化的FDA应用程序在市场上进行市场,这只需要他们证明其设备类似于已经使用的其他工具,通常需要大约六个月。根据在柳树的一项研究中,2015年至2020年的市场上市场的222 AI设备,92%通过510(k)。

从技术上讲,FDA不会“批准”GI Genius。该机构储备该术语,用于通过第三个,更严格的过程。

Medtronic向FDA提供了来自美国和欧洲的临床试验数据,欧洲显示GI Genius是安全的,并且它很少被严格地脱颖而出作为息肉。但是,虽然GI Genius可以帮助,确保医生在他们的最后一天的最后一个结肠镜检查时,Pochapin持怀疑态度,即AI将是一个游戏更换者。 “这是一个帮助我们做得更好的事情的工具,”Pochapin说。 “我认为我们不需要它,但我认为它会很好。”

结肠直肠癌是美国的第三次常见的癌症,但它应该可以预防。如果医生能够尽早找到那些癌前的生长,在他们成为一个问题之前,他们可以被删除。 “这应该是一个合理的期望,如果你每五年或十年透过结肠镜检查的麻烦,你不应该患上结肠癌,”华莱士说。但这取决于程序的质量。

GI Genius是一系列工具中的最新工具,可以改善结肠镜检查。 2012年,FDA清除了Endocuff,一个带有指状延伸的盖子,它附着在范围的末端,轻轻拉回结肠的褶皱。在过去的几年里,医生也研究了患者吞下含有蓝色染料的药丸的有效性,这使得更容易看到息肉。还有一些基本的人类做法,也可以帮助医生更彻底:确保他们在每次考试中花费足够的时间,并且护士观察也可以改善结果。


英文译文:

Michael Wallace has performed hundreds of colonoscopies in his 20 years as a gastroenterologist. He thinks he’s pretty good at recognizing the growths, or polyps, that can spring up along the ridges of the colon and potentially turn into cancer. But he isn’t always perfect. Sometimes the polyps are flat and hard to see. Other times, doctors just miss them. “We're all humans,” says Wallace, who works at the Mayo Clinic. After a morning of back-to-back procedures that require attention to minute details, he says, “we get tired.”

Colonoscopies, if unpleasant, are highly effective at sussing out pre-cancerous polyps and preventing colon cancer. But the effectiveness of the procedure rests heavily on the abilities of the physician performing it. Now, the Food and Drug Administration has approved a new tool that promises to help doctors recognize precancerous growths during a colonoscopy: an artificial intelligence system made by Medtronic. Doctors say that alongside other measures, the tool could help improve diagnoses. “We really have the opportunity to completely wipe out colon cancer in anybody who gets screened,” says Wallace, who consulted with Medtronic on the project.

The Medtronic system, called GI Genius, has seen the inside of more colons than most doctors. Medtronic and partner Cosmo Pharmaceuticals trained the algorithm to recognize polyps by reviewing more than 13 million videos of colonoscopies conducted in Europe and the US that Cosmo had collected while running drug trials. To “teach” the AI to distinguish potentially dangerous growths, the images were labeled by gastroenterologists as either normal or unhealthy tissue. Then the AI was tested on progressively harder-to-recognize polyps, starting with colonoscopies that were performed under perfect conditions and moving to more difficult challenges, like distinguishing a polyp that was very small, only in range of the camera briefly, or hidden in a dark spot.

The system, which can be added to the scopes that doctors already use to perform a colonoscopy, follows along as the doctor probes the colon, highlighting potential polyps with a green box. GI Genius was approved in Europe in October 2019 and is the first AI cleared by the FDA for helping detect colorectal polyps. “It found things that even I missed,” says Wallace, who co-authored the first validation study of GI Genius. “It's an impressive system.”

Mark Pochapin, a gastroenterologist at NYU Langone who was not involved in creating GI Genius, says it makes sense that AI would be good at recognizing polyps. “There is less diversity when you’re looking at polyps,” says Pochapin. The millions of colonoscopy videos provide plenty of data to make the algorithm comprehensive. That should shield the system from concerns about bias in other health care algorithms. “There are only so many varieties of polyps,” he says.

Medtronic sees GI Genius, and other AI tools, as a cornerstone of its future business, says Giovanni Di Napoli, president of Medtronic’s GI business. To that end, the company invested lots of time and resources into winning approval from the FDA for this device. “It took almost a year for us to get FDA approval,” says Di Napoli. “It’s not easy.”

Medtronic sought FDA clearance under what the agency calls its de novo pathway, which requires applicants to provide information about the safety and effectiveness of new devices including clinical data. This is a lengthier and more involved application that some other AI medical devices have avoided. Most AI and machine learning medical devices go on the market using a streamlined FDA application known as the 510(k) pathway, which only requires them to prove their devices are similar to other tools already in use and typically takes about six months. According to a study published in The Lancet, of the 222 AI devices that went on the market in the US between 2015 and 2020, 92 percent did so through the 510(k).

Technically, the FDA won’t “approve” GI Genius. The agency reserves that term for devices that go through a third, even more rigorous process.

Medtronic supplied the FDA with data from clinical trials in the US and in Europe that show GI Genius is safe and that it rarely misidentifies healthy colon as a polyp. But while GI Genius could help ensure doctors are as thorough on their last colonoscopy of the day as they are on their first, Pochapin is skeptical that AI will be a game changer. “This is a tool to help us do what we already do better,” says Pochapin. “I don’t think we need it but I do think it will be nice to have.”

Colorectal cancer is the third-most-common cancer in the US but it should be preventable. If doctors are able to find those pre-cancerous growths early, they can be removed before they become a problem. “It should be a reasonable expectation, if you go through the trouble of getting a colonoscopy every five or 10 years, you shouldn't you shouldn't get colon cancer,” says Wallace. But that depends on the quality of the procedure.

GI Genius is the latest in a series of tools that can improve colonoscopies. In 2012, the FDA cleared the Endocuff, a cap with finger-like extensions that attaches to the end of the scope and gently pulls back the folds of the colon. Over the last several years, doctors have also studied the effectiveness of having patients swallow a pill containing a blue dye that makes it easier to see the polyps. There are also some basic human practices that can also help doctors be more thorough: making sure they spend enough time on each exam and having the nurse observe can improve outcomes too.


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