The European Union has now granted regulatory clearance last week to the first-ever AI (Artificial Intelligence) tool that will analyse the X-rays automatically and autonomously. The name of this new device is CheckLink and it is an autonomous AI medical Imagine Suite that without oversight from a radiologist reads the chest X-rays. Developed by Oxipit which is a medical imaging company, CheckLink will exist alongside medical professionals as an essential and important thing of the clinical workflow. The company says it is a big achievement for them. They said that a big part of the last few years is spent by their radiologist on this.
How does it work?
CheckLink, the AI tool, is not only an X-ray device but more than this. It scans the chest X-rays of patients and then automatically sends the report of the patients on those that find it fully healthy or without any abnormalities. And when the reports do find any problem in the patient’s body the report is then sent to radiologists for their reviews. The device is helpful as it reduces the workload of the radiologist when the report is marked healthy because of the automatic scanning process. Saving the time of the radiologist by preparing reports and checking whether there are any potential health concerns, so is very helpful in overall tasks.
CheckLink got CE mark certification in the EU last week, ensuring that the device meets all the safety standards. The CE mark certification for the tech is like any item is getting clearance from the Food and Drug Administration in the US. But the latter one is harder to get than the former one as it is more informative and is not easy to get. CE clearance is easy to obtain. The CE certification made it a class llb health device. This means that the device is now safe to use with intensive care monitoring tools such as ventilators. After getting a certification from CE, Oxipit is now planning to get it certified from the FDA too.
The certification is not that easy either and one cannot say that CE clearance was easy for CheckLink but the device has been through a lot of testing. It reviewed approximately 500,000 real X-rays across multiple different locations and spent more than a year on these reviewings. The CEO of Oxipit, Gediminas Peksys said that during the piloting stage of the CheckLink, the sensitivity metric of 99 % was translated to 0 clinically relevant mistakes at their deployment institutions in a release.
The company stated that CheckLink will specifically be suitable in primary care offices, where the tool will help save time. Because in primary care offices there is almost 80 per cent of X-rays turn up normal, with no abnormalities. And the time that will be saved will be utilised on those patients that need it. But radiologists have concerns about the new technology as this can reduce their value of them and can fully substitute them one day and their profession will become fully automated. But Oxipit and experts say that these tools are not to replace human forces but to assist them in their work so that healthcare can be improved. But the mathematical proof is present before everyone to see that the AI technique is based on the singular idea of removing human radiologists. But Oxipit denies it by saying that the question of any mathematical performance does not arise when they can combine the AI capabilities and Human expertise.
It was stated by Oxipit that it expects that the very first healthcare organisations will be using this tool by 2023. Only CheckLink retrospective analysis AKA X-rays will be assigned by Oxipit because they are the ones that have been already reviewed by the radiologist. And when the tool gets a green mark by passing all the real-world tests it will then be used for the preliminary analysis.