Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has been stepping up efforts to bring innovative medical devices to market faster and make the regulatory approval process more predictable and further speed up approval processes that have been known for long delays.

PERTH, Australia – After unveiling its new regulatory framework for custom-made and 3D-printed devices, Australia’s Therapeutic Goods Administration (TGA) is now proposing further refinements due to pushbacks from stakeholder that manufacture custom-made and patient-matched devices.

HONG KONG – Singapore authorities have given provisional approval for a locally developed breath test for COVID-19. The test is developed by Breathonix Pte Ltd., a spin-off company from the National University of Singapore through its Graduate Research Innovation Program. The company said its Brefence Go COVID-19 breath test system was the first test of its kind to secure provisional authorization in Singapore.

The Guangzhou Sino-Israel Bio-industry Investment Fund (GIBF) has raised more than half of its proposed ¥2 billion (US$313 million) round. “The second fund, GIBF2, will focus on Israeli and European biotechnology companies, which are developing innovative drugs and are in phase II to III clinical trials,” Avner Lushi, the CEO and co-founder of the GIBF, told BioWorld.

Suzhou-based Intocare Medical Technology Co. Ltd. raised up to ¥100 million (US$15.66 million) in a series D funding round led by Qiming Venture Partners. Oriza Holdings, Oriza FOFs and Yuanbio Venture Capital also participated in the round. The company said the proceeds would be used for product R&D, clinical research, marketing promotion, and the launch of new offices and production sites.

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.