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Spine Systems Articles & Analysis

24 news found

FDA Accepts & Closes Empirical Spine`s Limiflex PMA Module II as a Motion-Preserving Alternative to Lumbar Fusion

FDA Accepts & Closes Empirical Spine`s Limiflex PMA Module II as a Motion-Preserving Alternative to Lumbar Fusion

When one segment of the spine is weakened and unstable, as in degen spondy, the spine flexes unevenly, with a disproportionate amount of the motion occurring at the unstable level. ...

ByEmpirical Spine, Inc.


Saluda Medical Announces Robust Scientific Presence at 2022 International Neuromodulation Society (INS) World Congress

Saluda Medical Announces Robust Scientific Presence at 2022 International Neuromodulation Society (INS) World Congress

Key data highlights with the Evoke® System to include holistic composite treatment outcomes for disrupting the chronic pain cycle; opioid-sparing effects of therapy; real-world results; and cost-effectiveness compared to open-loop stimulation. Saluda Medical Pty Limited (“Saluda Medical”), a global medical device company revolutionizing the field of neuromodulation with an ...

BySaluda Medical Pty Ltd.


eCential Robotics boosts its platform technology with a surgical robotic arm

eCential Robotics boosts its platform technology with a surgical robotic arm

Built on a range of applications ("Apps") currently dedicated to the spine, the system could be extended in the future to multiple indications of bone surgery. ...

ByeCential Robotics


Saluda Medical Receives FDA Approval for the EvokeĀ® Spinal Cord Stimulation System to Treat Chronic Intractable Pain

Saluda Medical Receives FDA Approval for the EvokeĀ® Spinal Cord Stimulation System to Treat Chronic Intractable Pain

The Evoke System is the first and only available SCS system capable of instantaneously reading, recording, and responding to evoked compound action potentials (ECAPs) – the nerves’ response to stimulation – to provide precise, continually optimized therapy. ...

BySaluda Medical Pty Ltd.


Saluda Medical Announces $125M Equity Financing Led by Redmile Group LLC and New Investors Fidelity Management & Research Company LLC and T. Rowe Price Associates, Inc.

Saluda Medical Announces $125M Equity Financing Led by Redmile Group LLC and New Investors Fidelity Management & Research Company LLC and T. Rowe Price Associates, Inc.

Saluda Medical Pty Limited (“Saluda Medical”), a global medical device company revolutionizing the field of neuromodulation with an emerging portfolio of therapies driven by advanced closed-loop technologies designed to treat debilitating neurological disorders, earlier this quarter finalized US $125 million in equity financing, led by existing investor Redmile Group LLC as well as ...

BySaluda Medical Pty Ltd.


Augmedics Announces FDA 510K Clearance and U.S. Launch of xvision, the First Augmented Reality Guidance System for Surgery

Augmedics Announces FDA 510K Clearance and U.S. Launch of xvision, the First Augmented Reality Guidance System for Surgery

Food and Drug Administration (FDA) 510(k) clearance and the U.S. launch of its groundbreaking xvision Spine system (XVS), the first AR guidance system to be used in surgery. xvision Spine allows surgeons to visualize the 3D spinal anatomy of a patient during surgery as if they had “x-ray vision,” and to accurately ...

ByAugmedics


Nevro Responds to Competitor`s Announcement of FDA Approval for Painful Diabetic Neuropathy

Nevro Responds to Competitor`s Announcement of FDA Approval for Painful Diabetic Neuropathy

REDWOOD CITY, Calif., Jan. 25, 2022 /PRNewswire/ -- Nevro Corp. (NYSE: NVRO), a global medical device company that is delivering comprehensive, life-changing solutions for the treatment of chronic pain, today responded to Medtronic's announcement of FDA approval for painful diabetic neuropathy (PDN). "PDN represents a very large potential market, and having another competitor validate this large ...

ByNevro Corp.


Nevro Announces FDA Approval for Expanded Labeling for its 10 kHz High Frequency Spinal Cord Stimulation System for Treatment of Non-Surgical Refractory Back Pain (NSRBP)

Nevro Announces FDA Approval for Expanded Labeling for its 10 kHz High Frequency Spinal Cord Stimulation System for Treatment of Non-Surgical Refractory Back Pain (NSRBP)

REDWOOD CITY, Calif., Jan. 19, 2022 /PRNewswire/ -- Nevro Corp. (NYSE: NVRO), a global medical device company that is delivering comprehensive, life-changing solutions for the treatment of chronic pain, today announced receipt of FDA approval for expanded labeling for its Senza® Spinal Cord Stimulation (SCS) System for the treatment of Non-Surgical Refractory Back Pain (NSRBP). This approval ...

ByNevro Corp.


Augmented Reality Pioneer Augmedics Announces New CEO in Support of Accelerating Growth

Augmented Reality Pioneer Augmedics Announces New CEO in Support of Accelerating Growth

Hykes’ appointment as CEO signals an exciting new chapter in Augmedics’ growth trajectory, and a commitment by investors to leverage the early commercial success of the xvision system in building a world-class augmented reality surgical guidance company. ...

ByAugmedics


Nevro Announces UnitedHealthcare Coverage for High-Frequency 10 kHz Therapy for the Treatment of Painful Diabetic Neuropathy

Nevro Announces UnitedHealthcare Coverage for High-Frequency 10 kHz Therapy for the Treatment of Painful Diabetic Neuropathy

REDWOOD CITY, Calif., Jan. 4, 2022 /PRNewswire/ -- Nevro Corp. (NYSE: NVRO), a global medical device company that is delivering comprehensive, life-changing solutions for the treatment of chronic pain, today announced that UnitedHealthcare, the largest private health insurance company in the United States, will provide coverage for the company's high-frequency 10 kHz Therapy for the treatment of ...

ByNevro Corp.


RIVANNA Announces Partnership with BOMImed to Increase Distribution of Accuro in Canada

RIVANNA Announces Partnership with BOMImed to Increase Distribution of Accuro in Canada

” The Accuro spinal navigation system is designed to improve the efficiency of spinal needle guidance procedures using groundbreaking technology, including Multi-Frequency BoneEnhance® Image Reconstruction, which provides enhanced visualization of lumbar and thoracic bony anatomy, and SpineNav3D™ AI-Based Spine Recognition, which provides ...

ByRivanna Medical


SIGNUS and eCential Robotics announce long-term partnership offering an optimized solution combining navigation, robotics and implant systems for spine surgeries

SIGNUS and eCential Robotics announce long-term partnership offering an optimized solution combining navigation, robotics and implant systems for spine surgeries

Gières (Grenoble), France, and Alzenau, Germany, September, 28 2021 – eCential Robotics, a French growth company that designs, manufactures, and markets the first unified 2D/3D robotic imaging and surgical navigation system for bone surgery indications, and SIGNUS, an international and family-run company based in Germany that has been the experienced specialist ...

ByeCential Robotics


Augmented Reality Pioneer Augmedics Announces Raj Asarpota as Executive Vice President and Chief Financial Officer

Augmented Reality Pioneer Augmedics Announces Raj Asarpota as Executive Vice President and Chief Financial Officer

“His extensive experience in leading the financial operations of spine-focused medical device business – as well as driving successful M&A transactions – will make him an immediate asset to the future of the Augmedics business. ...

ByAugmedics


Augmented Reality Pioneer Augmedics Announces New Board Leadership

Augmented Reality Pioneer Augmedics Announces New Board Leadership

“We are delighted to have the leadership of these two renowned industry veterans as we continue to bring xvision to surgeons across the U.S. and revolutionize the way spine surgery is done.” Anderson brings more than three decades of experience as an executive, investor, and board member for emerging growth and market-leading healthcare companies. ...

ByAugmedics


Saluda Medical Announces Publication of 24-Month Spinal Cord Stimulation Results with the EvokeĀ® System

Saluda Medical Announces Publication of 24-Month Spinal Cord Stimulation Results with the EvokeĀ® System

Results show ~90% overall back and leg responder rate, ~68% high responder rate, and zero explants due to loss of efficacy ~83% of patients reduced or eliminated opioid use Need for patient re-programming visits nearly eliminated after 12 months Represents the first peer reviewed SCS study to show responder and high responder rate improvement over time Saluda Medical Pty Limited ...

BySaluda Medical Pty Ltd.


Augmedics, Augmented Reality Surgical Image Guidance Pioneer, Raises $36 Million in Series C Fundraising

Augmedics, Augmented Reality Surgical Image Guidance Pioneer, Raises $36 Million in Series C Fundraising

Food and Drug Administration (FDA) 510(k) clearance and the launch of its xvision Spine System (XVS) in the U.S., the first and only FDA-approved augmented reality surgical image guidance system. ...

ByAugmedics


Dr. James Lynch is the First US Private Practice Surgeon to Use Augmented Reality Spine Surgical Guidance at a Community Hospital

Dr. James Lynch is the First US Private Practice Surgeon to Use Augmented Reality Spine Surgical Guidance at a Community Hospital

RENO, Nev., July 1, 2020 /PRNewswire/ — Spine Nevada Minimally Invasive Spine Institute announced that Dr. James Lynch, a board-certified and fellowship-trained neurological surgeon, was the first private practice surgeon in the United States to use the Augmedics xvision Spine System at a community hospital. xvision is the ...

ByAugmedics


Dr. Frank Phillips is First in the World to Use Augmented Reality Surgical Guidance in Minimally Invasive Spine Surgery

Dr. Frank Phillips is First in the World to Use Augmented Reality Surgical Guidance in Minimally Invasive Spine Surgery

The Augmedics xvision™ Spine System surgical guidance system allows a surgeon to see a patient’s 3-dimensional (3D) spinal anatomy through skin as if they have x-ray vision. ...

ByAugmedics


Augmedics Employees Lead $15 Million Series B Financing to Secure and Successfully Launch Company Amid COVID-19 Crisis

Augmedics Employees Lead $15 Million Series B Financing to Secure and Successfully Launch Company Amid COVID-19 Crisis

Food and Drug Administration (FDA) 510(k) clearance and the U.S. launch of its xvision Spine system (XVS), the first AR guidance system to be used in surgery. xvision Spine allows surgeons to visualize the 3D spinal anatomy of a patient during surgery as if they had “x-ray vision,” and to accurately navigate ...

ByAugmedics


First Augmented Reality Spine Surgery Using FDA-Cleared Augmedics xvision Spine System Completed in U.S.

First Augmented Reality Spine Surgery Using FDA-Cleared Augmedics xvision Spine System Completed in U.S.

The xvision Spine System takes the best of surgical navigation systems and improves upon them to meet the needs of surgeons and provide technical confidence in the operating room. ...

ByAugmedics

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