Claritas iPET™ Approved by Australia TGA to Supply the Medical Software Device for Image Processing Enabling Diagnostic Quality Images from Short Scan Time and/or Low Dose ...

Claritas NucMed Technologies Ltd (Claritas), a healthcare technology company specializing in state-of-the-art image enhancement, noise reduction, segmentation and quantification, and related AI ...

Skyhawk Announces Australia's Therapeutic Goods Administration Has Determined SKY-0515 for Huntington's Disease Meets Eligibility Criteria for Registration via the Provisional ...

Australia's Therapeutic Goods Administration (TGA), responsible for approval of the safety, quality, and efficacy of therapeutic goods, has determined that Skyhawk's SKY-0515 orally-administered small ...
Citizen Tribune

Optellum Secures TGA Approval to Expand AI-Enabled Lung Nodule Solution To Australia

Optellum, the leading AI-enabled solution for earlier lung cancer detection, is thrilled to announce that it has received ...
Nasdaq

Beyond Air, Inc. Announces TGA Market Authorization for LungFit® PH Medical Device in Australia

Beyond Air's LungFit PH receives TGA authorization in Australia for delivering nitric oxide via ventilators, enhancing respiratory care capabilities. The press release includes multiple ...
Business Wire

Owlet Launches TGA-Approved Dream Sock™ in Australia & New Zealand, Expanding International Footprint and Bringing Trusted Pediatric Health Monitoring to More Families Worldwide

SYDNEY--(BUSINESS WIRE)--Owlet, Inc. (“Owlet” or the “Company”) (NYSE: OWLT), the pioneer of smart infant monitoring, today announces that Dream Sock ™ is now available for families across Australia ...
Nasdaq

Australia Therapeutic Goods Administration (TGA) Grants Provisional Registration for Novavax COVID-19 Vaccine

GAITHERSBURG, Md., Jan. 19, 2022 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious ...
Business Wire

Croma Australia Pty Ltd, a subsidiary of Hugel Aesthetics, Receives TGA Approval in Australia for LETYBO (letibotulinumtoxinA) for the Treatment of Glabellar Lines

NEWPORT BEACH, Calif.--(BUSINESS WIRE)--Hugel America, Inc., (Hugel Aesthetics), today announced it received Therapeutic Goods Administration (TGA) approval for LETYBO (letibotulinumtoxinA) to treat ...
BioWorld

COVID-19 disrupted Australia’s business but the TGA still met its goals

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 ...
The Australian

TGA recalls two more Australian sunscreens over suspect SPF claims

The Therapeutic Goods Administration pulled Outside Beauty and Skincare’s SPF 50+ Mineral Primer and Salus Body & Spa’s SPF 50+ Daily Facial Sunscreen from shelves on Monday. A TGA investigation found ...