PERTH, Australia – The majority of medical device and biopharma industry respondents agreed that Australia’s Therapeutic Goods Administration (TGA) responded effectively to COVID-19, but they want to see the agency improve its processes to act faster and with more clarity, according to the TGA’s annual stakeholder survey.
PERTH, Australia – Perth-based regenerative medicine company Orthocell Ltd. saw its shares rise 27% on the heels of its first U.S. approval for its collagen medical device for dental guided bone and soft tissue regeneration applications. “It’s an important milestone for us, and one that came quicker than I was expecting it to come,” Orthocell CEO Paul Anderson told BioWorld. The company submitted its 510(k) application to the FDA in May, and he was expecting approval by the middle of 2021.
PERTH, Australia – Australia’s Medical Technologies and Pharmaceuticals Industry Growth Center (MTPConnect) is boosting funding for the translation and commercialization of research in diabetes, cardiovascular disease and regenerative medicine.
PERTH, Australia – Perth-based regenerative medicine company Orthocell Ltd. received marketing clearance from Australia’s Therapeutic Goods Administration (TGA) for its Celgro collagen medical device for dental guided bone and soft tissue regeneration applications. The approval validates the Celgro platform technology and clears the way for further approvals in nerve and tendon repair, Orthocell CEO Paul Anderson told BioWorld.
PERTH, Australia – The COVID-19 pandemic certainly put pressure on Australia’s Therapeutic Goods Administration during the 2019 to 2020 year, but it also showed that the agency was able to rise to challenge and not buckle under pressure, revealing a number of strengths that the agency will build upon, the TGA said in its annual performance report.
PERTH, Australia – Australia is employing some new genomic tools to help identify SARS-CoV-2 infections and track them within communities. Illumina Inc. and the University of Melbourne have partnered to establish the Illumina-University of Melbourne Genomics Hub – a first for the Asia-Pacific region – which will bring together the best of genomic expertise and technology in Australia.
PERTH, Australia – Researchers at the QIMR Berghofer Medical Research Institute in Queensland have developed a way of testing whether COVID-19 patients’ immune systems are gearing up to fight the virus that causes the disease.
PERTH, Australia – Med-tech company Control Bionics began trading on the Australian Securities Exchange (ASX:CBL) Dec. 7 in an IPO that saw the company raise AU$15 million (US$11.25 million). Melbourne-headquartered Control Bionics develops assistive technologies (AT) that allow people with severe disabilities to communicate and control electronic devices using electromyography (EMG).
PERTH, Australia – Australia's Therapeutic Goods Administration (TGA) is requiring manufacturers of permanently implantable devices to provide patient implant cards and consumer device leaflets with their devices, beginning Dec. 1. New implantable devices will need to comply by Dec. 1, 2020, and existing implantable devices will have until Dec. 1, 2021, to comply.
PERTH, Australia – Australia’s Therapeutic Good Administration (TGA) has unveiled its final regulatory requirements for personalized medical devices, including 3D-printed devices, that go into effect on Feb. 25, 2021. Under the previous framework, custom-made medical devices were exempt from the requirement to be included in the Australian Register of Therapeutic Goods (ARTG).