PERTH, Australia – See-Mode Technologies has received 510(k) clearance from the U.S. FDA to market its Augmented Vascular Analysis (AVA) program that uses artificial intelligence (AI) to analyze vascular ultrasound scans to better predict stroke. Caused by plaque that ruptures in blood vessels and blocks blood flow to the brain, stroke affects roughly 15 million people per year and is the second-leading cause of death globally.

PERTH, Australia – During the COVID-19 pandemic, 90% of Australia’s clinical trials were put on hold, and the market cap of biotech and medical device companies on the Australian Securities Exchange dropped 5% to AU$11 billion (US$7.78 billion), according to a recent report by Australia’s Medical Technologies and Pharmaceuticals Industry Growth Centre.

PERTH, Australia – Astrazeneca plc is leasing 175 Sozo devices from Impedimed Ltd. and plans to put them in 20 countries to run phase II trials for a combination drug that looks at fluid imbalance in the human body in patients with heart failure (HF) and chronic kidney disease.

PERTH, Australia – Epi-Minder Pty. Ltd. has completed an oversubscribed series A round of AU$18 million (US$12.89 million) that will see its Minder epilepsy monitoring device enter a pivotal trial to support marketing applications in Europe and the U.S. The smartphone-enabled device promises to improve on wearables and other tools – such as patient diaries – that have proven to be unreliable.

Lumos Diagnostics Holdings Pty. Ltd. scooped up AU$25 million (US$17.9 million) in an oversubscribed pre-IPO ahead of its anticipated 2021 listing on the Australian Securities Exchange (ASX). The funds will be used to expand manufacturing operations in California and Florida and to grow the commercial footprint of Febridx, a rapid point-of-care (POC) test that can determine if a person has a viral or bacterial infection within 10 minutes.

PERTH, Australia – Astrazeneca plc is leasing 175 Sozo devices from Impedimed Ltd. and plans to put them in 20 countries to run phase II trials for a combination drug that looks at fluid imbalance in the human body in patients with heart failure (HF) and chronic kidney disease.

PERTH, Australia – Starpharma Holdings Ltd. completed a AU$45 million (US$32 million) placement to domestic and international investors that will see it advance its COVID-19 antiviral nasal spray. The treatment is based on the company’s antiviral dendrimer, SPL-7013.

PERTH, Australia – Regenerative medicine company Mesoblast Ltd. saw its stock drop 37% on the news that it received an FDA complete response letter to its BLA for Ryoncil (remestemcel-L) for the treatment of pediatric steroid-refractory acute graft-vs.-host disease.

PERTH, Australia – Astrazeneca plc is leasing 175 Sozo devices from Impedimed Ltd. and plans to put them in 20 countries to run phase II trials for a combination drug that looks at fluid imbalance in the human body in patients with heart failure (HF) and chronic kidney disease.

PERTH, Australia – Regenerative medicine company Mesoblast Ltd. saw its stock drop 37% on the news that it received an FDA complete response letter to its BLA for Ryoncil (remestemcel-L) for the treatment of pediatric steroid-refractory acute graft-vs.-host disease.