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On May 27th, Shukun coronary AI assisted diagnosis products and Shukun pneumonia AI assisted diagnosis products both obtained the EU MDR CE certificate.
diagnosis
CE certification is the entry threshold required for medical device products to enter most countries centered on Europe, while MDR is a new version of the regulations issued by the European Commission in compliance with the development of the medical device industry, which proposes changes to the clinical evaluation and testing of products before marketing.
On May 5, 2017, the European Union officially released a new version of the medical device regulation MDR (EU 2017/745), which replaced the old medical device directive MDD (93/42/EEC).
Under the new MDR regulations, medical devices entering the European market will be subject to stricter restrictions.
Heart vascular disease is the number one disease, illness and death rates in the first place.
Heart blood vessels
It is reported that the coronary AI products of Shukun Technology can meet the requirements of superiority.
Pneumonia is the most common disease in the world.
There are currently 500 million people in Europe, and there is a huge patient population in both cardiovascular and pulmonary diseases.
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