PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) will begin accepting applications from domestic companies to become conformity assessment bodies (AU CAB) beginning July 1. The aim is to allow approved Australian corporations to issue conformity assessment certification for medical devices under Australian law to align with the country’s essential principles.

A first-of-its-kind blood test that can detect whether cancer is absent, imminent, or present in different stages is on its way to the market. This is a claim made by brothers Ashish Tripathi and Anish Tripathi, who lead Singapore-based molecular diagnostic company Tzar Labs Pte. Ltd. and Mumbai-based Epigeneres Biotechnology Pvt. Ltd., respectively.

Esco Lifesciences Group Ltd. has closed what it claims to be the largest private fundraising round by an Asia-based life sciences tools company. The Singapore-headquartered life sciences product company raised $200 million in an oversubscribed series A and crossover round. The financing was led by Vivo Capital and Novo Holdings A/S, with participation from new investors, including China Investment Corp. and Singapore-based global investor EDBI.

PERTH, Australia – Emvision Medical Devices Ltd.’s stroke helmet could potentially transform care for stroke patients by treating them at the bedside or before they even get to the hospital. The company’s portable, non-ionizing brain scanner is capable of rapidly producing quality images to help paramedics determine if a stroke is ischemic or hemorrhagic.

PERTH, Australia – With half the world’s population, Asia Pacific is quickly replacing Europe as the world’s second-largest medical device market, and China, Korea and Australia stand out as leaders, said Tim Schmid, company group chairman for Johnson & Johnson Medical Devices, Asia Pacific, during the recent Ausmedtech 2021 virtual conference.

HONG KONG – Genetron Holdings Ltd. is teaming up with JD Health International Inc. to develop full-cycle cancer management solutions encompassing both online and offline components. The partnership will focus on the six key areas of consumer health care, digitization of liver disease management, government medical associations, sharing of customer screening resources, industry, and user education as well as the consolidation of oncology doctors and experts on a single platform.

PERTH, Australia – As D-Day approaches for the European Medical Device Regulations (MDR), Australia is also nearing completion of implementing its own medical device reforms, which closely mirror the EU MDR. “We had to look at aligning as close as possible with the EU system, but we’ve had to align with a moving, incomplete and delayed target, and the TGA asked us to move ahead of the EU reforms,” said John Skerritt, deputy secretary, Health Products Regulation for the Therapeutic Goods Administration (TGA), during the recent Ausmedtech virtual conference.

PERTH, Australia – Six classes of medical devices listed on Australia’s Register of Therapeutic Goods (ARTG) will fall under new classification requirements on Nov. 25, 2021, following numerous consultations with industry. The consultations were part of the Australian government’s plans to overhaul its medical device regulations to be more in line with the European Medical Device Regulation (MDR).

HONG KONG – Dia Imaging Analysis Ltd. has teamed up with Sonoscape Medical Corp. to deliver cardiac ultrasound artificial intelligence (AI) solutions. The partnership aims to reduce the variability associated with manual or visual analysis, and increase efficiency and accuracy throughout the analysis process. As a result, China-based Sonoscape's ultrasound devices will be offering a layer of automated AI-based analysis to support the clinician’s decision-making process, courtesy of Dia's AI-based cardiac solutions.

PERTH, Australia – The launch of Australia’s first medical device development and manufacturing facility in Melbourne is set to fast-track new treatments for people with conditions such as epilepsy, Parkinson’s disease, hearing loss, stroke and diabetes.