The U.S. FDA gave the 510(k) green light to Echo IQ Ltd.’s Echosolv AS for its AI-enabled software as a medical device to be used as a decision support aid in detecting severe aortic stenosis.

Australia is the skin cancer capital of the world, but with a shortage of dermatologists, patients often wait too long to get skin checks that could end up costing them their lives.

Australia is the skin cancer capital of the world, but with a shortage of dermatologists, patients often wait too long to get skin checks that could end up costing them their lives.

TGA opened a consultation for regulation of assistive technologies, a key element of which is to make determinations about the regulatory status of some of these products. While the agency makes clear that some items that are currently unregulated may soon be subject to regulation, one of the more innocuous-seeming articles that may fall under regulation is the common and seemingly innocuous wig.

Skin biopsies could be a thing of the past thanks to the development of a new non-invasive microneedle patch to pre-screen for skin cancer. Dermr Health Solutions Pty Ltd. founder and CEO Stefan Mazy told BioWorld that the fledgling genomics startup company is pushing the boundaries of science with its Dermr patch that quickly and painlessly extracts live skin cells in 15 seconds, drastically cutting the time and discomfort associated with traditional biopsy procedures.

Skin biopsies could be a thing of the past thanks to the development of a new non-invasive microneedle patch to pre-screen for skin cancer. Dermr Health Solutions Pty Ltd. founder and CEO Stefan Mazy told BioWorld that the fledgling genomics startup company is pushing the boundaries of science with its Dermr patch that quickly and painlessly extracts live skin cells in 15 seconds, drastically cutting the time and discomfort associated with traditional biopsy procedures.

AI-focused medical diagnostics company Spectral AI Inc. is collaborating with burn wound therapy company Polynovo Ltd. to test limited deployment of Spectral’s Deepview system for predicting burn healing in Australia.

Australia’s Therapeutic Goods Administration (TGA) made significant changes to some of its regulations, including those for software-based medical devices. The TGA said that entities that are switching their products to a higher risk classification can continue to offer them for six months after Nov. 1, 2024, if they have an application on file with the TGA, but only if the sponsor notified the agency of such intent prior to May 25, 2022.