RapidAI Receives TFDA Approval for Commercial Use

中文 

Taipei, TAIWAN — September 23, 2021 — RapidAI, the global leader in neurovascular imaging driving the next evolution of clinical decision making and patient workflow, is pleased to announce that it has received approval from the Taiwan Food and Drug Administration (TFDA) for its Rapid CTA, Rapid CTP, Rapid MRI, and Rapid for Angio products and is now commercially available to hospitals and health systems in Taiwan. It is currently being used in 10+ hospitals in Taiwan and more than 1800 hospitals in over 60 countries.

According to the Taiwanese Ministry of Health and Welfare, one in six of the Taiwan population suffer from a stroke at least once in their lifetime, and the cerebrovascular disease is one of top five causes of death in the country, taking an average of 10,000+ lives each year. For patients and their families every second counts when it comes to treatment, as research shows patients can lose nearly 1.9 million neurons every minute in which stroke is yet to be treated. Shortening the diagnosis time for doctors has then become a key for patient's survival after a stroke.
The first step of shortening diagnosis and treatment time is streamlining imaging and communications. When a stroke patient arrives to the emergency room, he/she typically undergoes a brain computed tomography, or CT scan, as well as other medical imaging such as a Multimodal CT or MRI to provide sufficient images for doctors to evaluate their condition and decide next steps.

With the RapidAI platform, developed by an experienced team of neurologists, radiologists, technologists and entrepreneurs, care teams are able to more easily view CT images, make quicker decisions, and get patients treatment faster.

Specifically, Rapid CTP can provide quantitative and color-coded models in just two minutes for doctors to assess salvageable brain tissue quickly. RapidAI can also quickly calculate the number and proportion of salvageable brain tissue and necrotic brain tissue, so doctors can determine whether the patient is still suitable for rt-PA or endovascular thrombectomy.

RapidAI also optimizes the medical team’s workflow by enabling doctors to immediately view a patient's status through the Rapid mobile app, share the images with other members of the care team, and discuss the patient’s diagnosis, anytime and from anywhere.

“With an easy-to-use interface, Rapid automatically selects ischemic brain images indicated for thrombolysis and/or thrombectomy for the stroke team. The implementation of Rapid has shortened the door-to-recanalization time and helped more patients receive efficient treatments,” said Dr. Nai-Fang Chi, Department of Cerebrovascular, Neuromedicine Center of Taipei Veterans General Hospital.

RapidAI is a highly recognized and widely used medical imaging platform worldwide. The 2018 DAWN and DEFUSE 3 studies, which were conducted using Rapid, were the primary research that led the American Heart Association (AHA) and the American Stroke Association (ASA) to update their acute stroke treatment protocols, extending the treatment window for acute stroke patients from 6 to 24 hours.

Dr. I-Hui Lee, Director of Department of Neurology and Cerebrovascular in Taipei Veterans General Hospital, shared: "We are happy that Rapid has been approved by Taiwan FDA for clinical applications. We believe this will also help more stroke teams in Taiwan to provide high-quality and efficient treatment for patients."