The latest global regulatory news, changes and updates affecting medical devices and technologies, including: HQO recommends home UVB therapy; Health Canada announces testing advisory panel.
PARIS – Esight Corp. is starting distribution of its newest low-vision assistive technology in France, Germany and the U.K. The latest version of the technology, the Esight 4, was designed to be more versatile and mobile than before, has double the display brightness and has improved the auto-focus function, according to the company.
There has been a recent renaissance in the interest in radiopharmaceuticals used for diagnostic and therapeutic applications, as well as their combined use (theranostics). A recent Canadian partnership between Admare Bioinnovations and the Centre for Probe Development and Commercialization (CPDC) aims to take advantage of the country’s expertise in the field and leverage promising radiopharmaceutical innovations into potential commercial opportunities.
TORONTO – A Canadian plant-based, cellulose scaffold implant for regenerating healthy spinal cord tissue has received U.S. FDA breakthrough device designation. The designation will enhance the process by which Ottawa-based Spiderwort Inc. interacts with the FDA during regulatory review of the Cellubridge implant, said Spiderwort CSO and cofounder Andrew Pelling, speeding its way to clinical trials.
TORONTO – Biomaterials med-tech company 3D Biofibr Inc. has raised CA$550,000 (US$423,500) seed funding to develop, commercialize and scale up a biofilm platform that mimics the spinning behavior of the common spider.
TORONTO – Toronto-based Sqi Diagnostics Inc. has reported significant clinical progress developing three novel COVID-19 tests for submission for U.S. FDA emergency use authorization.
TORONTO – Whether it’s President Trump obtaining the drug Regeneron or COVID-19 test kits fast tracked in the U.S. and Canada, this has been the year of temporary emergency approvals for drugs and medical devices. What is sometimes overlooked are permanent programs like Canada’s Special Access Program and the U.S.’s Expanded Access Program, designed to provide therapeutics to patients who have exhausted every avenue for a cure or relief from a devastating disease.
Researchers at Ontario’s University of Waterloo have developed a palm-sized device that uses radio waves to read blood glucose levels, as well as artificial intelligence (AI) software to get near instantaneous results.
TORONTO – What’s the difference between an organ transplant container tucked under a paramedic’s arm and an ordinary beer cooler packed with ice? Surprisingly, not much, according to researchers at London, Ontario’s Western University. They’ve come up with a portable, temperature-controlled container that prevents spoilage of donor organs during transport to the operating room – and of potential vaccines.
TORONTO – Health Canada has approved a portable COVID-19 test kit which began as a testing regime for identifying pathogens, microbes and viruses in the European food and natural products industry. The Hyris Bcube developed by Guelph, Ontario-based Songbird Life Science Inc., in partnership with London, U.K.’s Hyris Ltd., is described as a portable DNA-based “laboratory in a box” for coronavirus testing in large urban spaces as well as more remote, indigenous communities in Canada’s north.