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Home » Authors » David Godkin

Articles by David Godkin

Theradaptive wins breakthrough device designation for spinal implant

Dec. 10, 2021
By David Godkin
Theradaptive Inc. has received an FDA breakthrough medical device (BMD) designation for its Osteo-Adapt SP spinal fusion implant for transforaminal lumbar interbody fusion to treat degenerative disc disease, spondylolisthesis, or retrolisthesis. Under the program Theradaptive will enjoy priority review for its spinal bone growth implant and interactive advice for continued development as well as clinical trial protocols during premarket review.
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Savvywire image

Savvywire at center of successful 20-patient cardiac study

Dec. 8, 2021
By David Godkin
TORONTO – Opsens Inc. has successfully treated 20 patients in the first-in-human study employing a new surgical guidewire to improve procedural workflow during transcatheter aortic valve replacement (TAVR). According to Opsens CEO Louis Laflamme, the Savvywire will be the first guidewire to deliver a valvular prosthesis while allowing continuous hemodynamic pressure measurement during the procedure.
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Cancer cells under magnifying glass

Canada approves Koios’s AI-driven, breast cancer ultrasound software

Dec. 1, 2021
By David Godkin
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.
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Canada pinned on globe

COVID-19 changing face of med-tech adoption, says new Medtech Canada CEO

Nov. 22, 2021
By David Godkin
TORONTO – Despite high tech costs and tight public sector budgeting, COVID-19 has driven Canadian procurement offices to echo a sentiment uttered by average Canadians, “Damn the costs. Give us something that really works.”
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Tumor microenvironment image obtained using multiphoton microscopy and endogenous fluorescence

Oncocyte launches immunotherapy response prediction test to bring cancer cells out into the open

Nov. 17, 2021
By David Godkin
TORONTO – Oncocyte Corp. launched Determaio, an immunotherapy response prediction test it said is “the first to comprehensively assess the tumor microenvironment.” This is important because of how smart cancer cells are in that microenvironment, Oncocyte CEO Ronnie Andrews told BioWorld, commandeering natural tissue repair biology and condensing immunological T cells so they back off attacking cancerous tissue.
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Mazor spinal navigation and robotic platform

Medtronic Canada launches Mazor spinal navigation and robotic platform

Nov. 11, 2021
By David Godkin
TORONTO - Medtronic Canada ULC, a subsidiary of Dublin-based Medtronic plc, has launched what it calls the “the first dedicated robotic assisted spine surgery platform in Canada.” The Mazor integrates surgical planning, workflow and execution by combining navigation and robotic technologies.
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Business pipeline illustration

Trillium lab gets C$1M to close gap between high performing algorithms and patient outcomes

Nov. 3, 2021
By David Godkin
TORONTO – Trillium Health Partners has received a C$1 million (US$810,000) grant from TD Bank Group to help accelerate the use of artificial intelligence (AI) at a newly developed health care lab. The AI Deployment and Evaluation (AIDE) lab will determine if machine learning models developed by industry and academia work well outside the data sets upon which they were trained.
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Doctor using Moleculight DX on foot wound

Moleculight partners with Joerns Healthcare to distribute new wound imaging device

Oct. 29, 2021
By David Godkin
TORONTO – Imaging company Moleculight Inc. has launched a new point-of-care, wound imaging platform intended for multiple U.S. health care settings and has also inked a deal with a U.S. distributor to ensure it gets there.
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Pathway Medical app on multiple tablet, smartphone screens

Investors spend C$1.6M to expand AI-driven medical decision-making platform

Oct. 22, 2021
By David Godkin
TORONTO – Pathway Medical Inc. has raised C$1.6 million (US$1.3 million) in an oversubscribed funding round to expand its evidence-based clinical decision support platform and deliver an enterprise version of its point-of-care technology. The current mobile app uses natural language processing and machine learning to give doctors evidence-based answers to questions on patient diagnosis and treatment.
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Radialis PET system photo

Radialis submits premarket notification for its organ-targeted PET camera

Oct. 8, 2021
By David Godkin
TORONTO – Radialis Medical Inc. has submitted FDA premarket notification for a positron emission tomography system (PET) that targets specific organs for low dose imaging and may be flexible enough to assess many different diseases. The Radialis PET camera is under clinical investigation at Toronto’s University Health Network and Princess Margaret Cancer Center for its ability to assess anomalies in breast cancer.
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