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BioWorld - Tuesday, December 16, 2025
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Canada expands regs to protect drug, device supplies

Sep. 2, 2021
By Mari Serebrov
Even as the Biden administration pushes for drug imports from Canada as a way to help curb U.S. prescription drug prices, Canada is doubling down on its efforts to protect its supply of drugs and medical devices.
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Hand holding money plant

Fluid Biotech raises $4.7M for a world’s first in brain stent development

Aug. 24, 2021
By David Godkin
TORONTO – Fluid Biotech Inc. has raised $4.7 million in oversubscribed seed funding to further develop and commercialize the world's first hybrid polymer-metal flow-diverting brain stent for curing brain aneurysms that can lead to stroke. Following successful preclinical studies of the stent, attention now turns to applying this fresh capital to hiring contract manufacturers to prepare for first-in-human implantation and production of the mostly polymer-constructed stent.
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Patient undergoing cognitive testing with Champ

Voxneuro cognitive platform to launch following Canadian and FDA approvals

Aug. 13, 2021
By David Godkin
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.
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Sample rendering of Sievrt

Health Canada likes what it sees in Sievrt VR radiology platform

Aug. 6, 2021
By David Godkin
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.
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Swift Medical’s mobile app

Swift Medical raises $35M to break silence around wound care technology

Aug. 6, 2021
By David Godkin
TORONTO – A “silent epidemic” all but “ignored” by medical technology developers. That’s how Carlo Perez, founder and CEO of Swift Medical Inc., described the hesitancy of the industry to directly tackle chronic wound care through development of more advanced medical imaging and diagnostic systems. Undaunted, U.S. and Canadian investors have raised $35 million in series B funding to advance development and uptake of Swift Medical’s own AI-powered, digital wound care platform.
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Canada’s Rx price review board slapped for overstepping its bounds

Aug. 5, 2021
By Mari Serebrov
Canada’s Federal Court of Appeal took the Patented Medicine Prices Review Board to task for ordering Alexion Pharmaceuticals Inc. to “forfeit excess revenues” generated by Soliris (eculizumab) between 2009 and 2017.
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Canada’s patent system steps forward to catch up

Aug. 4, 2021
By Mari Serebrov
For the first time ever, Canada will be granting patent term adjustments beginning in January. That’s welcome news for the biopharmaceutical and med-tech industries, and it’s long overdue, Jeffrey Morton, a partner at Snell & Wilmer LLP, told BioWorld.
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Hand holding ADAMM-RSM device

Wearable asthma device tested for its prediction of chronic pulmonary disease

July 26, 2021
By David Godkin
TORONTO – What do ER doctors want most for their patients? Never to return to the ER, said Giovanni Ferrara, a professor at Edmonton’s University of Alberta Hospital's Division of Pulmonary Medicine. Ferrara is heading a feasibility project to see if a wearable device developed by Rochester, N.Y.-based Heath Care Originals Inc. can predict with scientific certainty when the condition of a patient with lung disease is worsening and requires another visit to the hospital.
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Lock on digital globe illustration

Cyber threats: Enough is enough, nations tell China

July 20, 2021
By Mari Serebrov
Responding to the growing number of state-sponsored cyber threats to health care and other key sectors and to the compromise of the Microsoft Exchange Server, which was disclosed in March, Canada, the EU, U.K., U.S. and other NATO allies issued statements July 19 laying out expectations and markers for how responsible nations behave in cyberspace and specifically calling out China’s “malicious cyber activity.”
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Illustration of spine before and after Miscoli

VBT device for treating adolescent scoliosis awarded breakthrough device designation

July 13, 2021
By David Godkin
TORONTO – Spino Modulation Inc., a subsidiary of Montreal-based med-tech company Spinologics Inc., has received breakthrough device designation for a vertebral body tethering (VBT) device to treat adolescent idiopathic scoliosis, one of three types of scoliosis that cause the spine to develop an abnormal curve.
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