TORONTO – Koios Medical Inc. has received Health Canada approval for its DS Smart Ultrasound decision support software, which the company said accurately interprets breast ultrasound examinations. Company CEO Chad McClennan told BioWorld greater accuracy will provide early cancer detection rates, while reducing costly false positives and unnecessary biopsies.
Emergent Biosolutions Inc.’s Bayview facility in Baltimore passed its manufacturing inspection with international regulators, clearing the way for shipment of batches of Johnson & Johnson’s (J&J) COVID-19 vaccine containing drug substance made at the plant.
The world of artificial intelligence (AI) regulation is still in its infancy, but a number of agencies are nonetheless keen on harmonization for at least some of this policymaking task. The FDA announced recently that it has joined with Health Canada and the U.K. Medicines and Healthcare Products Regulatory Agency to develop a series of 10 guiding principles for good machine learning practices (GMLP), thus answering one of the key questions facing developers of these algorithms.
TORONTO – Western New York Imaging Group, a one-hour drive across the U.S.-Canadian border, will soon be the site for a hard launch of Champ, a system developed by Voxneuro Inc. that evaluates suspected cognitive brain disorder or symptoms such as fatigue, memory loss or brain fog. This comes after Voxneuro won FDA registration of the cognitive platform as a class II exempt medical license, followed last month by Health Canada approval of the system for help diagnosing concussion, traumatic brain injury and dementia.
TORONTO – Health Canada has green-lighted an all-in-one virtual reality (VR) platform for use in diagnostic radiology. Software developer Luxsonic Technologies Inc. said the award of a class II medical device license to its mobile Sievrt suite of diagnostic tools is the first time a VR system of this kind has been approved by a national regulatory agency.
TORONTO – Health Canada has proposed a single regulatory framework for medical device and drug clinical trials after broad industry consultation and a hard line drawn by the COVID-19 pandemic for a more streamlined system.
TORONTO – Ambu Inc. has won Health Canada clearance for a flexible, single-use cystoscope for diagnosing, managing, and treating lower urinary disorders such as incontinence and bladder cancer. The disposable Ascope 4 Cysto system goes head-to-head with reusable urology scopes that must be reprocessed after each use, diminishing image quality and mechanical performance, said Jens Kemp, Ambu’s vice president of marketing for North America.
TORONTO – For Scott Kadwell, president of Markham, Ontario-based RSK Medical Inc., the distributor tagged to sell the Health Canada approved Gammacore Sapphire, the device represents “a shift from a business to business to a direct-to-consumer business model.” For Rockaway, N.J.’s Electrocore Inc. which developed the self-administered technology, it’s one more regulator to have greenlighted the FDA cleared, CE-marked device for treating intractable migraine and cluster headache.
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