FzioMed, a US-based privately held medical device company, has included its Dynavisc on the Australian Register of Therapeutic Goods (ARTG). Dynavisc is an absorbable, viscoelastic gel that is applied to tendons and peripheral nerves to ...
Tags: FzioMed, medical device
The release of the new ISO standards for Consumer Product Safety (ISO 10377) and Consumer Product Recall (ISO 10393) has been greeted with enthusiasm from the grocery sector. These two new ISO standards, developed in parallel and with the ...
Tags: Consumer Safety, New Standards
Optimer Pharmaceuticals has announced the approval of Dificid (fidaxomicin) Tablets by the Australian regulatory body, the Therapeutic Goods Administration. Specialised Therapeutics Australia that has license to fidaxomicin in Australia ...
Therapeutic Goods Administration in Australia and the National Institute of Surveillance of Medicine and Foods in the Ministry of Health in Colombia have approved ElectroCore's non-invasive, non-pharmaceutical vagus nerve stimulation ...
Tags: ElectroCore, Therapeutic Goods, Medicine
Regenerative therapies company Cytomedix has received clearance from the Therapeutic Goods Administration (TGA) to commercialize its Angel cPRP system in Australia. The approval allows the company to use the system in the clinic or ...
Tags: Cytomedix, TGA, Angel cPRP system
SinuSys has received regulatory approvals from Health Canada and Australian Therapeutic Goods Administration (TGA) for its AerOs sinus dilation system, designed for the treatment of chronic sinusitis. Designed for use in office-based ...
Tags: SinuSys, Health Canada, Australian Therapeutic Goods Administration
The Therapeutic Goods Administration (TGA), the regulatory body for therapeutic goods in Australia, has prohibited sale, supply and use of DMAA (1,3-dimethylamylamine), an ingredient used in some sports supplements. The TGA noted that it ...
Tags: therapeutic goods, sports supplements, reports of adverse effects
Australian Therapeutic Goods Administration (TGA) has cleared Genzyme's once daily oral Aubagio 14mg dose for the treatment of relapsing multiple sclerosis (MS). Aubagio, which has anti-inflammatory properties, is expected to minimize ...
The Therapeutic Goods Administration (TGA) of Australia has approved Ikaria Lucassin (terlipressin) for the treatment of Hepatorenal Syndrome Type 1 (HRS 1) in patients who are actively being considered for a liver transplant. The ...