Coreline Soft, a medical artificial intelligence (AI) company, said on Friday that it obtained medical device certification (pre-market authorization) from the Singapore Health Sciences Authority (HSA) for nine of its AI-based  solutions on Saturday.

Coreline Soft obtained medical device certification (pre-market permission)  from the Singapore Health Sciences Authority (HSA) for nine of its AVIEW solutions on Saturday.
Coreline Soft obtained medical device certification (pre-market permission)  from the Singapore Health Sciences Authority (HSA) for nine of its AVIEW solutions on Saturday.

The certificate includes AVIEW products for analysis of lung and pulmonary diseases, coronary disease, a medical image 3D modelling and printing solution and an automated organ segmentation solution.

In particular, Singapore is one of the ASEAN member countries adhering to the Common Submission Dossier Template (CSDT), enabling ASEAN member countries to quickly respond to licensing among the 10 ASEAN members.

The CSDT is the application standard developed under the ASEAN Medical Devices Directive (ASEAN MDD) to harmonize the regulatory requirements in the region and reduce the entry burden for foreign manufacturers by limiting the alterations needed prior to application submission. It is similar to the 510(k) premarket notification in the U.S. and the CE marking in Europe.

Coreline Soft is speeding up its overseas licensing process to increase its presence in the global medical market leading with its flagship AI chest diagnosis solution, AVIEW LCS PLUS.

Prior to this certification, Coreline Soft acquired approval from the US FDA, European CE, Japan PMDA, and Taiwan TFDA. Additionally, it also obtained the medical device single audit program (MDSAP) in February this year which allows MDSAP members like the U.S. (FDA), Health Canada (MHLW), Japan (MHLW), Australia (TGA), and Brazil (ANVISA) to conduct a single regulatory audit of a product which satisfies the requirements of the regulatory authorities participating in the program with a a three-year validity period.

"With this certification, we will explore export markets in the Asian medical AI market, including Singapore, which is known as the medical hub in Southeast Asia, and actively promote new cooperation opportunities," Coreline Soft CEO Choi Jung-pil said.

He added that the company plans to become a comprehensive medical imaging solution encompassing the entire patient management experience from examination, diagnosis, treatment, and prognosis in the future.

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