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BioWorld - Friday, December 19, 2025
Home » Topics » North America » Canada

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Device image

Front Line’s small aortic occlusion device approved in Canada

March 3, 2021
By David Godkin
TORONTO – Front Line Medical Technologies Inc. reported Health Canada approval for a device deemed the smallest for use in emergency situations when patients require hemodynamic support to maintain blood flow to the brain and heart. According to biomedical engineer, co-founder and Front Line CEO Asha Parekh, the Cobra-OS is the world’s smallest REBOA (Resuscitative Endovascular Balloon Occlusion of the Aorta) device.
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Regulatory front for Feb. 22, 2021

Feb. 22, 2021
By Mark McCarty
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Health Canada clarified RUO policy.
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Hand in medical glove holding device

Puzzle Medical solves FDA approval process with breakthrough device designation

Feb. 19, 2021
By David Godkin
TORONTO – Puzzle Medical Devices Inc. has been granted a U.S. FDA breakthrough device designation for a transcatheter heart pump designed for fragile patients with few minimally invasive options for treating advanced heart failure.
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Person in hospital scrubs uses Snapshot

Kent’s deal with Net Health to expand Snapshot’s footprint

Feb. 17, 2021
By David Godkin
TORONTO – Think of it. More than 14,000 facilities boasting 98% of the largest hospital chains across the U.S., two-thirds of skilled nursing facilities and hospice organizations and doctors’ offices. It’s that broad customer base Kent Imaging Inc. will have access to following its Jan. 26 agreement with medical software and analytics giant Net Health Inc., helping to expand the footprint of Kent Imaging’s Snapshot device for assessing non-healing wounds, notably those arising from diabetes.
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Illustration of vascular system in the legs

Soundbite Medical device for treatment of CTOs approved in Canada

Feb. 16, 2021
By David Godkin
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.
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Dollar sign in lightbulb

Kardium ups its game with $115M investment in atrial fibrillation ablation device

Feb. 1, 2021
By David Godkin
TORONTO – Kardium Inc. has secured US$115 million in private money to accelerate commercial growth in Europe of a mapping and ablation system for atrial fibrillation (AF), and conduct a clinical study for FDA approval of the system. Led by Fidelity Management & Research Co. LLC, this funding tranche follows a US$40 million investment in Kardium in 2018 driven by T. Rowe Price Associates Inc., which also invested this time around.
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Woman stands in front of COVID-19 screening system

Health Canada approves Monitio’s COVID-19 screening system

Jan. 29, 2021
By David Godkin
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.
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Software screenshot

Circle wins Ottawa funding support for its AI-driven cardiovascular imaging platform

Jan. 27, 2021
By David Godkin
TORONTO – Calgary-based Circle Cardiovascular Imaging Inc. is receiving CA$2.65 million (US$2.09 million) in funding from the Canadian government’s Western Diversification Program (WDP), which represents nearly half of the more than CA$5.5 million (US$3.35 million) investment made to four Alberta-based organizations and companies. Company CEO Greg Ogrodnick attributes this to Circle Cardiovascular’s position “as the world leader in cardiovascular imaging.”
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Hand holding "Acquisition" piece over puzzle

Acquisition of Collective Medical boosts Pointclickcare’s upward climb

Jan. 25, 2021
By David Godkin
TORONTO – Pointclickcare Technologies Inc. has followed up a series of private sector investments and purchases with its acquisition of Collective Medical Inc. and its real‐time notification platform for streamlining transitions from one stage of health care to another and reducing unnecessary length of stay and patient admissions. One of this country’s largest software companies, Pointclickcare said the US$500 million plus acquisition will pair its “rich, post‐acute data set” with Collective Medical’s network of more than 1,300 hospitals and other health care organizations across 39 states.
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Epstar 2F (top), Epstar 6F (bottom)

Epstar 2F goes where no other coronary catheter has gone before

Jan. 11, 2021
By David Godkin
TORONTO – The 2-French Electrophysiology Catheter (2F) had its Canadian launch in mid-December at Toronto’s Sunnybrook Health Sciences Centre where electrophysiologist Benedict Glover used it to map the small, tortuous branches of the coronary sinus in a patient suffering from cardiac arrhythmia. Developed by Toronto-based Baylis Medical Inc., the 2F is expected to work in tandem with the company’s larger 6F catheter to help diagnose comparatively rare but complex heart arrhythmias.
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