PERTH, Australia – Australian digital health company Resapp Health Ltd. was down nearly 52% following news that the U.S. FDA rejected its de novo request for its smartphone application for the diagnosis and management of respiratory disease. The agency rejected the application, citing the need for additional information to demonstrate that the “clinical benefits of the device outweigh the risks,” CEO Tony Keating told analysts during a March 12 conference call on the news.
PERTH, Australia – Six classes of medical devices listed on Australia’s Register of Therapeutic Goods (ARTG) will fall under new classification requirements on Aug. 25, 2020, 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).
PERTH, Australia – On the heels of scoring a CE mark for its Novosorb biodegradable temporizing matrix (BTM) in the EU, Melbourne-based Polynovo Ltd. crossed its first AU$2 million (US$1.3 million) month in December sales for its initial commercial product.
PERTH, Australia – After more than three years of consultations, Australia’s Therapeutic Goods Administration (TGA) finally has unveiled a new regulatory framework for custom-made and 3D-printed devices that aligns with international standards.
PERTH, Australia – Australian medication adherence technology firm Adherium Ltd. is relaunching itself after a management reshuffle and a successful capital raise of AU$5.4 million (US$3.5 million) to deploy a new commercial strategy.
PERTH, Australia – With the Brexit split now official, Australia’s Therapeutic Goods Administration (TGA) is trying to figure out the impact to its life sciences industry and the new trade relationships that will take effect after the transition period ends on Dec. 31, 2020.
PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) has issued a draft guidance to help sponsors better understand the evidence requirements for market authorizations for medical devices, including in vitro diagnostics (IVDs) and software as a medical device (SaMD).
PERTH, Australia – Brisbane, Australia-based Field Orthopaedics was formed when a group of orthopedic surgeons were exasperated by ongoing shortcomings in surgical practice and decided to do something about it.
PERTH, Australia – As of Feb. 12, Australia’s Department of Health confirmed 15 cases of novel coronavirus in Australia (five in Queensland, four in New South Wales, four in Victoria and two in South Australia). Of the confirmed 15 cases, five people have recovered and the others are in stable condition.
PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) is seeking input from industry stakeholders on a proposal to increase its fees to cover projected deficits this year. The proposal outlines three options.