SpinaFX receives CE Mark MDR for Triojection®

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SpinaFX News

SpinaFX Medical Receives CE Mark MDR Certification for its Triojection® System

SpinaFX Medical Receives CE Mark MDR Certification for its Triojection® System, Expanding Access to Minimally Invasive Lumbar Disc Treatment Across Europe and Key International Markets

TORONTO, July 15, 2026 /CNW/ — SpinaFX Medical Inc. (“SpinaFX”), a Toronto‑based medical device company specializing in image‑guided, minimally invasive spine care, today announced it has received Medical Device Regulation (MDR) CE Mark certification for its Triojection® System (MDR 843778). This certification enables commercial introduction of Triojection across the European Union and

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John Soloninka appointed CEO at SpinaFX Medical

SpinaFX Medical announces John Soloninka as Chief Executive Officer

SpinaFX Medical Inc. is pleased to announce the appointment of John Soloninka as Chief Executive Officer. John joined SpinaFX in 2021, as the first executive hire, taking progressive roles as COO, CTO and CSO. His leadership and expertise were critical in establishing the company with ISO 13485/MDSAP certification and achieving major

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FDA Grants Triojection IDE for its breakthrough, minimally-invasive image-guided lumbar disc treatment

SpinaFX Medical receives FDA Investigational Device Exemption (IDE) for Triojection®, its Breakthrough, Minimally-Invasive, Image-Guided Lumbar Disc Treatment.

The prospective, randomized, multicenter trial will compare intradiscal ozone/oxygen injection plus nerve root block to nerve root block alone in 300 patients in up to 30 US sites TORONTO, June 9, 2026 /CNW/ – SpinaFX Medical, a clinical-stage medical device company specializing in minimally invasive, image-guided therapies for intravertebral disc disorders, today

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FDA Designates Triojection® as a Breakthrough Device

FDA Designates Triojection® as a Breakthrough Device

TORONTO, Aug. 15, 2025 /CNW/ – SpinaFX Medical Inc., (“SpinaFX”) a leading innovator in image-guided interventional spine care, is proud to announce that its flagship device, Triojection®, has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA). This milestone acknowledges Triojection’s potential to offer a highly

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Jodi Menezes - Head of Clinical Affairs at SpinaFX

Jodi Menezes joins SpinaFX as Head of Clinical Affairs

We have recently welcomed Jodi Menezes to SpinaFX as Head of Clinical Affairs. Jodi joins us from Johnson & Johnson, with a decade of experience in the MedTech industry, where she has built a strong foundation in driving business growth, operational efficiencies, and strategic market expansion. In her role as Head of Clinical Affairs at

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Group of professionals networking and discussing at the SpinaFX.com event booth

SpinaFX at GRIBOI 2025 – Advancing Conversations in Spine Care

April 10-12, 2025 SpinaFX was honored to participate in the 33rd Interdisciplinary Research Conference on Injectable Osteoarticular Biomaterials and Bone Augmentation (GRIBOI), held at the Fairmont Banff Springs Hotel in Banff, Alberta, Canada. At Booth #3, our team engaged with interventional spine and pain specialists, researchers, and industry leaders from

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A medical professional of Spina FX giving a presentation on spinal imaging to a group of doctors

Advancing Spine Care: SpinaFX’s Educational Workshop at GRIBOI 2025

Banff, Alberta, Canada  SpinaFX, a Canadian company focused on developing minimally invasive, image-guided treatments for back pain caused by contained herniated discs, proudly participated in the 33rd Interdisciplinary Research Conference on Injectable Osteoarticular Biomaterials and Bone Augmentation (GRIBOI 2025). Held from April 10 to 12 at the Fairmont Banff Springs

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Back pain treatment pathway infographic showing diagnosis, conservative care, spinal injections, SpinaFX ozone therapy, and surgical discectomy options

SpinaFX Completes its Series B Funding Round

Advancing Innovative Spinal Treatment for Contained Herniated Discs [Toronto, Canada, 18th of December – 2024] – SpinaFX Medical Inc., an innovator in minimally invasive image-guided spinal care solutions, proudly announces the successful completion of its Series B funding round, raising its last tranche of CAD $5.3 million. “This investment, led by a

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SpinaFX Medical Applauds Clinical Trial Results

SIR Abstract of the Year study highlights promising treatment option for lumbar disc herniation with radiculopathy TORONTO, ONTARIO, January 17, 2023—Minimally invasive image-guided therapy company, SpinaFX Medical Inc. (SpinaFX), applauds the results of a randomized control trial conducted in Europe that demonstrated non-inferiority of intradiscal oxygen-ozone therapy to microdiscectomy for

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SpinaFX Medical Achieves ISO 13485:2016/MDSAP and EN ISO 13485:2016 Certification

TORONTO, Nov. 9, 2022 /PRNewswire/ – Minimally invasive image-guided treatment solution and technology company, SpinaFX Medical Inc. (SpinaFX), today announced the quality management system underlying its Triojection® system has been certified compliant with ISO 13485:2016/Medical Device Single Audit Program (MDSAP) for U.S. and Canada and EN ISO 13485:2016 for Europe.

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