Deep01 awaiting second US FDA clearance for AI medical detection system
Mark Tsai, Taipei; Rodney Chan, DIGITIMES

Deep01, a Taiwan-based medical artificial intelligence (AI) startup, is applying for its second US FDA (Food and Drug Administration) clearance for midline shift detection and measurement, according to the company's CEO, David Chou.

The company said it obtained its first FDA clearance for intracranial hemorrhage detection AI system, which can produce results within 30 seconds, in July this year.

Earlier this month at the annual meeting of the Radiological Society of North America (RSNA), Chou, CEO of Deep01, presented a new function of brain computer tomography (CT) called "AI quantitative calculation of midline shift."

"Midline shift" is an important indicator that helps emergency physician to detect the degree of midline shift for diagnosing acute cerebrovascular disease and allows neurosurgeons to decide whether to perform craniotomy according to the degree of shift after reviewing CT images, he said. The AI system helps to calculate the degree of midline shift, which can shorten the decision time of the clinician, and the patient can obtain the corresponding treatment faster, and then has a better prognosis.

The Deep01 CEO noted that medical innovation in various countries is robust. In the process of collaborating with medical companies across Europe, America, and Asia, he claimed that Taiwan AI healthcare has its industrial advantages.

At the RSNA meeting, Deep01 discussed opportunities for cooperation with more than 10 international companies including CT (computer tomography), PACS (picture archiving and communication system), and telemedicine companies.

Deep01, established at the end of 2016, is the first medical AI startup in Taiwan and Asia-Pacific to obtain FDA clearance in the United States. There are about 12 employees, and some medical doctors have joined part-time.

The company said its next step is to market products overseas, cooperate with foreign CT companies, and also establish partnerships with domestic and foreign PACS companies.

Deep01 at RSNA

Deep01 CEO David Chou (second right)
Photo: Company

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