PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) has issued a draft guidance to help sponsors better understand the evidence requirements for market authorizations for medical devices, including in vitro diagnostics (IVDs) and software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).
Brisbane, Calif.-based Caption Health Inc. received good news from the U.S. FDA, which has given a thumbs up to Caption Guidance. This software aims to assist medical professionals in the acquisition of cardiac ultrasound images and uses artificial intelligence (AI) to provide real-time guidance.
IDbyDNA Inc., a San Francisco-based metagenomics technology company, scooped up $20 million in series B financing in a round led by Artis Ventures. Genesys Capital and others participated in the round. The company plans to use the money to accelerate uptake of its Explify software platform.
IDbyDNA Inc., a San Francisco-based metagenomics technology company, scooped up $20 million in series B financing in a round led by Artis Ventures. Genesys Capital and others participated in the round. The company plans to use the money to accelerate uptake of its Explify software platform.
PERTH, Australia – Australia’s Parliament has passed the first tranche of medical device regulations reforms that follow a number of consultations over the last two years.
LONDON – Cognetivity Neurosciences Ltd. has received CE software as a medical device approval for its cognitive assessment tool, a five-minute test intended as a diagnostic aid to identifying the earliest stages of dementia.
HONG KONG – South Korea’s Medical IP Co. Ltd., an artificial intelligence (AI)-based medical 3D printing and software company, has won the FDA’s nod for its medical imaging analysis solution Medical Image Processing (Medip).
HONG KONG – Boston-based consulting firm Analysis Group Inc. will be working with China’s Institute of Hematology & Blood Diseases Hospital (IHBDH) on developing a first-of-its-kind blood disease research platform. The National Longitudinal Cohort of Hematological Diseases in China (NICHE) is set to hold the information of more than 10,000 patients across China.
TORONTO – Montreal’s Dialogue Technologies Inc. has received class 1 CE marking for artificial intelligence (AI)-powered software that enables the company’s existing telehealth platform to reduce the time required to triage patients in emergencies. The new AI-driven Dialogue Intake software also has “human-in-the-loop” capability ensuring real-time medical intervention to verify the accuracy of information provided physicians during telehealth consultation.
The U.S. FDA has engaged in an overhaul of its software policies in the wake of the mandates spelled out by the 21st Century Cures Act. However, those policies are still a work in progress, as a recent FDA webinar made clear. The FDA won’t have long to put those policies into place as the U.S. House of Representatives is considering a follow-on to the Cures Act, dubbed Cures 2.0, which will impose yet more changes on the agency’s approach to software regulation.
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