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RainMed products have obtained the national sales license issued by the local medical device regulatory authority in Serbia

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  • Time of issue:2021-12-20 17:03
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(Summary description)On October 21st, 2021, Suzhou RainMed Medical Technology Co., Ltd. (hereinafter referred to as "RainMed") announced that its products Coronary Analysis System caFFR (model ASC15) and Disposable Blood Pressure Transducer (model CPT-1500) have obtained the national sales license issued by the local medical device regulatory authority in Serbia, which marks the launch of caFFR in Serbia.

RainMed products have obtained the national sales license issued by the local medical device regulatory authority in Serbia

(Summary description)On October 21st, 2021, Suzhou RainMed Medical Technology Co., Ltd. (hereinafter referred to as "RainMed") announced that its products Coronary Analysis System caFFR (model ASC15) and Disposable Blood Pressure Transducer (model CPT-1500) have obtained the national sales license issued by the local medical device regulatory authority in Serbia, which marks the launch of caFFR in Serbia.

  • Categories:News Center
  • Author:
  • Origin:
  • Time of issue:2021-12-20 17:03
  • Views:
Information

On October 21st, 2021, Suzhou RainMed Medical Technology Co., Ltd. (hereinafter referred to as "RainMed") announced that its products Coronary Analysis System caFFR (model ASC15) and Disposable Blood Pressure Transducer (model CPT-1500) have obtained the national sales license issued by the local medical device regulatory authority in Serbia, which marks the launch of caFFR in Serbia.

Currently, RainMed focuses on the field of precision diagnosis and treatment of cardiovascular diseases and has developed caFFR and caIMR, two core products of digital functional diagnosis module. caFFR is based on conventional angiographic images for three-dimensional vascular reconstruction. It uses dedicated pressure sensors to capture real-time aortic pressure and calculates FFR values with optimized computational fluid dynamics algorithms. Compared with FFR value derived from the traditional guide wire, the diagnostic consistency of caFFR is up to 95.7%, which is the highest comparison consistency of FFR diagnostic products at present. caFFR has strong friendly human-machine interaction, and has the characteristics of safety, efficiency, accuracy, and simplicity. In 2019, caFFR obtained NMPA certification in China and CE certification in the European Union. At present, it has achieved large-scale admission sales in China and overseas, and has offered clinical service to nearly a thousand hospitals.

RainMed's product caIMR addresses the operational challenges of quantitative microcirculation measurement, providing a better prognosis evaluation without the need for pressure guidewires and vasodilators and additional surgical procedures of the operator. It is reported that the product has entered the clinical trial stage and is expected to be marketed by the end of next year.

At the same time, RainMed will also implement the new strategy, attach great importance to product development and technical innovation. Relying on the technical accumulation in control algorithm, image navigation, image intelligence, evidence-based medicine and other aspects, RainMed will launch vascular interventional surgical robot in the future and gradually form "unmanned operating room", which can free clinicians from tedious and time-consuming work, empower and serve clinicians.

"Whether FFR or IMR, our goal is to provide physicians and patients with a better tool to evaluate patients' myocardial ischemia at a macro and micro level before, during, and after surgery."

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