PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) has issued a draft guidance to help sponsors better understand the evidence requirements for market authorizations for medical devices, including in vitro diagnostics (IVDs) and software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).

The results from a study comparing San Diego-based Bionano Genomics Inc.’s Saphyr to traditional cytogenetic methods for the clinical analysis of leukemia genomes revealed that the system was 100% concordant with the standard of care for the detection of somatic chromosomal abnormalities.

PERTH, Australia – As of Feb. 12, Australia’s Department of Health confirmed 15 cases of novel coronavirus in Australia.

BEIJING – Researchers from The Hong Kong Polytechnic University (PolyU) have developed a diagnostic system that they claim is the world’s most comprehensive as it can identify 30 to 40 pathogens in one single test within an hour.

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.

Guilford, Conn.-based Hyperfine Research Inc. has received the U.S. FDA’s nod for a bedside magnetic resonance imaging (MRI) system and is eyeing this summer for shipments. The portable system can be wheeled directly to the patient’s bedside and plugs into a standard electrical wall outlet.

LONDON – Consumer smartphone apps that use image processing algorithms to assess and monitor potentially cancerous skin lesions have not been properly tested in clinical trials and cannot be relied on to produce accurate results, according to a systematic review of published studies.