ASX-listed medtech Singular Health Group has been given the green light to continue developing and manufacturing its 3Dicom diagnostic medical software in Perth after retaining its global regulatory certification.
The company today revealed it has now retained the international standard of certification for medical devices that is a prerequisite for continued regulatory approval for distribution across the majority of global markets. Management says the retention of its “ISO13485” certification demonstrates ongoing adherence to best-in-class global standards for quality assurance and medical device development.
The clearance proves Singular’s continued compliance with regulatory and quality requirements of Health Canada, the Therapeutic Goods Administration in Australia, and the United States Food and Drug Agency (FDA) through that country’s Medical Device Single Audit Program.
ISO13485 is the primary standard for medical device development and manufacture and has been globally adopted by almost all leading medical device regulatory bodies as a prerequisite for the registration of Class II and higher medical devices.
Singular’s 3Dicom medical device allows medical practitioners such as dentists, surgeons and radiologists to convert conventional 2D MRI, CT and PET scans into immersive 3D images. The change provides a clearer insight into a patient’s medical problems and enables better surgical planning.
The product comes in three distinct categories – 3Dicom MD is used by medical practitioners for diagnosis and treatment, 3Dicom Patient allows patients to store medical records and works in conjunction with practitioners using the 3Dicom MD software, while 3Dicom R&D is primarily used as a learning and teaching aid in education facilities, including universities, around the world.
In addition to its regulatory clearance certification, the recent relocation of Singular’s software development activities from its previously Subiaco-based office to the consolidated Bibra Lake premises required notification to the FDA, British Standards Institute (BSI) and additional quality and regulatory updates due to its status as a Medical Device Establishment (MDE). An onsite site verification audit at Bibra Lake was combined with the required annual surveillance audit and submitted for panel review with BSI.
The successful passing of our annual surveillance audit by BSI, an independent auditing body, demonstrates our strong commitment to quality and risk management in our development of diagnostic medical software and enables us to seek further regulatory approvals on a global scale. Singular Health Group managing director and chief executive officer Denning Chong
Just this month, the company announced the receipt of a binding purchase order for its patented 3Dicom technology from Las Vegas-based Roseman University in Nevada. Management says Roseman is the first US college to adopt the 3Dicom R&D software as a medical education tool in a market forecast to be worth some US$17.6 billion (AU$26.8 billion) by 2027.
Earlier this year, Singular also revealed it had locked in its first enterprise order for 3Dicom in the US, with 5000 licenses purchased by Techworks 4 Good on behalf of American veterans. It will allow veterans to upload and share medical records from their 3Dicom Patient account through online, desktop and mobile applications, greatly improving accessibility, portability and continuity of care.
Late last year, the company’s 3Dicom R&D software was selected as the medical education program of choice by Majmaah University in Saudi Arabia, with an initial order of 20 annual licenses.
Is your ASX-listed company doing something interesting? Contact: office@bullsnbears.com.au