TORONTO – Soundbite Medical Solutions Inc. has received Health Canada approval for a shock wave device that jackhammers its way through calcified, chronic total occlusions (CTO) in life-threatening critical limb ischemia (CLI), a severe form of peripheral artery disease. This comes after the Active Wire 0.014” was used for the first time in late January to successfully treat five patients.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: MITA announces new health care supplier standard; Laggardly patient record response costs provider $75k; New med-tech resource platform now includes logistics; Spectrascience the subject of speculation, SEC action; HC nudging along with regulatory modernization plan.
TORONTO – Startup CEOs may sometimes be forgiven a little exuberance on learning their technology has received the high sign from regulatory officials. So it was when the head of Monitio Intelligence Inc. Ben Su sifted through his email at his office in Coburg Ontario and saw the Health Canada logo at the top of the letter. “I was actually jumping up and down when I received that authorization letter. I was very excited,” Su said. Since then Su has been overseeing installation of an automated COVID-19 screening system.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Health Canada updates list of recognized standards; FTC posts draft consent agreement for Flo Health; Two more snared in PGx testing scam.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: USTR seeking input on nations with poor IP protections; NICE sticks with ABI to evaluate PAD; Health Canada to extend COVID-19 flexibilities.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA eyes grant of license for spectrometer for SARS; HQO eyes TAVI/TAVR for low-risk patients; ACLA says testing capacity beginning to strain.
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.
The COVID-19 pandemic has not run its course, but the U.S. FDA is already working on a plan for handling devices in the period after the public health emergency ends. Bill Maisel, chief medical officer at the FDA’s Center for Device and Radiological Health (CDRH), said the agency is thinking through what would have to appear in a guidance for a transition that may span a number of months, providing industry with some much-needed breathing room.