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Spinal System 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

LimiFlex is intended to be an alternative to spinal fusion, which has persistent and well-documented drawbacks, including being highly invasive and expensive and carrying a high risk of surgery-related complications and re-operations. ...

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 EvokeĀ® 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. ...

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

GiĆØres (Grenoble), France, June 17, 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, unveiled its surgical robotic arm as a world premiere at the annual meeting of the French Society of Spinal Surgery (SFCR), ...

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

ā€œThe groundbreaking technology behind the Evoke System’s ability to intelligently measure spinal cord activation has had many of us excited for a long time,ā€ said Nagy Mekhail, MD, PhD, Professor at the Cleveland Clinic Lerner College of Medicine, Director of Evidence-Based Pain Medicine Research and Education in the Department of Pain ...

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.

Net proceeds from the financing will be used to operationalize and scale commercialization of the EvokeĀ® Spinal Cord Simulation System (SCS) for chronic pain and to further advance the Company’s technology platform across an emerging portfolio of transformational neuromodulation therapies. ...

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 ā€œx-ray vision,ā€ and to accurately navigate instruments ...

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)

(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 SenzaĀ® Spinal Cord Stimulation (SCS) System for the treatment of Non-Surgical Refractory Back Pain (NSRBP). This approval is specific to Nevro's ...

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

Augmedics, a pioneer in augmented reality (AR) surgical navigation, today announced its newest executive leadership addition in support of the accelerating growth of the company’s revolutionary AR-driven xvision system. The company announced the appointment of medtech executive Kevin Hykes as President and Chief Executive Officer. Hykes is a 30-year medical device veteran with expertise ...

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

Keith Grossman, Chairman, CEO and President of Nevro. "As the only spinal cord stimulation system that is FDA approved to treat PDN, we believe we are uniquely positioned to treat the thousands of patients suffering from the debilitating effects of PDN with a proven non-drug option. ...

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

It signifies a migration away from palpation-based needle placement in favor of a safer and more efficient image-guided standard for spinal needle placement.ā€ The Accuro spinal navigation system is designed to improve the efficiency of spinal needle guidance procedures using groundbreaking technology, including ...

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

The SIGNUS pedicle screw system is a safe, modular and economical fixation system for all interventions on spine. ...

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

Augmedics, a pioneer in augmented reality surgical image guidance, today announced that Raj Asarpota has been appointed executive vice president and chief financial officer, effective September 15, 2021. In this role, Asarpota will lead Augmedics’ global finance organization and will be responsible for accounting, treasury, financial planning and analysis, tax, and investor relations. ...

ByAugmedics


Augmented Reality Pioneer Augmedics Announces New Board Leadership

Augmented Reality Pioneer Augmedics Announces New Board Leadership

Augmedics, a pioneer in augmented reality surgical image guidance, today announced the appointment of Rick Anderson as executive chairman of the board and Bradley Paddock as the board’s independent director. Anderson joined the board in March upon the closing of Augmedics’ over-subscribed $36 million Series C funding, followed by Paddock in May. Both will begin their new roles ...

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

The study is the world’s first multicenter spinal cord stimulation study to demonstrate these levels of profound pain relief scores and functional outcome measures at 24 months highlighting the restorative benefits for patients implanted with Saluda’s proprietary EvokeĀ® Spinal Cord Stimulation (SCS) System. ...

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

The xvision Spine System allows surgeons to visualize the 3D spinal anatomy of a patient during surgery as if they had ā€œx-ray vision,ā€ and to accurately navigate instruments and implants while looking directly at the patient, rather than a remote screen. ...

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

The xvision Spine System uniquely builds and improves upon existing surgical navigation systems to meet the surgeons’ needs and provide technical confidence in the operating room. ...

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 xvisionā„¢ 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 ā€œx-ray vision,ā€ and to accurately navigate instruments and implants ...

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.

Augmedics, a pioneer in augmented reality surgical image guidance, has announced its groundbreaking xvision Spine System has been successfully used for the first time in a spinal fusion surgery in the United States. The system was used in a spinal surgery procedure by Johns Hopkins University surgeons. xvision, the first ...

ByAugmedics

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