PERTH, Australia – As Australia prepares to reopen the country after strict lockdown measures, the TGA is making a new regulation to allow companies to supply their COVID-19 rapid antigen self-tests for home use beginning Nov. 1. “There’s light at the end of the tunnel for Australians on a number of fronts,” said Health Minister Greg Hunt in a Sept. 28 press conference.

Broncus Holding Corp.’s shares tumbled more than 20% on its first trading day on Friday, Sept. 24, in Hong Kong. It raised HK$1.55 billion (US$199.1 million) at HK$18.70 a share, the top end of its target range. Nearly half of the proceeds will be used for the R&D and commercialization of its two core interventional pulmonology products: the Intervapor system and the RF Generator + RF Ablation Catheter (RF-II).

PERTH, Australia – Atmo Biosciences Ltd. has closed an oversubscribed AU$9.6 million (US$7 million) capital raise that will allow it to further develop its gas-sensing capsule for monitoring the health of the gut and the microbiome. Until now, there has not been a diagnostic test that can measure gases in the gut in vivo.

Nec Corp. is branching out into new health care and life science businesses, which will make use of artificial intelligence (AI) and other digital technologies. It is targeting a business value of ¥500 billion (US$4.56 billion) for these new areas by 2030. “Nec already announced this in our Mid-term Management Plan 2025 and is creating this health care and life sciences business to help drive future growth. As to why we chose 2030, it relates back to our Nec 2030VISION outlined in the plan,” an Nec spokesperson told BioWorld.

The COVID-19 pandemic is still swirling about, and rapid antigen tests are still playing a vital role in pushing back against the COVID-19 pandemic, and Australia’s TGA has responded with a guidance on when software used with rapid antigen tests qualifies as a regulated device. The TGA has classified such software as a class 3 device when used with a rapid antigen self-test, thus requiring a separate regulatory application before it can be eligible for entry in the Australian Register of Therapeutic Goods (ARTG).

PERTH, Australia – Changes to Australia’s medical device requirements have resulted in certain devices no longer requiring TGA conformity assessment certification, including class IV in vitro diagnostics (IVDs). As of July 23, 2021, devices that contain drugs or materials of animal, microbial, recombinant or human origin no longer require mandatory TGA conformity assessment certification. Instead, sponsors of these devices will be able to provide conformity assessment documents issued by notified bodies designated by a European Union member state to support their applications on the Australian Register of Therapeutic Goods (ARTG).

Cureapp Inc. is ready to take the next step for its digital therapeutic app (DTA) for hypertension, after completing a late-stage clinical trial and publishing the results. The company said it is the first global trial for a therapeutic app, conducted to seek regulatory approval in the field of hypertension.

The med-tech market in China has lured many device makers and investors into doing business there despite concerns about intellectual property (IP) theft. While some of those IP theft worries have eased, China’s National Medical Products Administration (NMPA) is still implementing an order that came into force June 1, creating an environment of massive regulatory uncertainty that will force device makers to navigate carefully when attempting to access the world’s largest med-tech market.

Lunit Inc. won an innovative medical device designation from South Korea’s Ministry of Food and Drug Safety (MFDS). The designation was for Lunit Insight MMG, its commercial artificial intelligence (AI) solution for breast cancer detection from mammography images. The company said that Lunit Insight MMG is now the first medical device of its type to receive the designation, and the company now has its second innovative medical device designation. “All of our commercialized products are now designated innovative medical devices by the MFDS. We will ensure that our Lunit Insight AI products allow medical staff to rapidly and accurately diagnose patients,” said Beomseok Suh, CEO at Lunit.

PARIS – Researchers at the Institute for Surface Technologies and Photonics in Weiz, Austria, and the Institute of Scientific and Industrial Research Osaka University, Japan, have invented new ultra-flexible health monitoring patches that use harvested bio-mechanical energy. “These new devices represent a wireless e-health patch for accurate pulse and blood pressure monitoring,” Andreas Petritz, from the Institute for Surface Technologies and Photonics (the materials research unit of Joanneum Research FmbH), told BioWorld.