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Spine Remodeling 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

Empirical Spine, Inc., a medical device company creating a new class of spinal implant that works in parallel with the natural structures of the spine to restore functionality and optimize quality of life, recently had its Premarket Approval (PMA) Module II accepted and closed by the US Food & Drug Administration (FDA), an important milestone in the commercial approval process for its ...

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

Gières (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), which is being held from June 17 to ...

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

Transformative closed-loop technology senses the spinal cord’s response to stimulation and instantaneously adjusts therapy to sustain durable, optimized treatment Long-term results published in two premier clinical journals show clinically meaningful improvements in pain relief, physical and emotional functioning, sleep quality, and health-related quality of life Saluda Medical Pty ...

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

Augmedics, a pioneer in augmented reality surgical image guidance, has announced U.S. 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 ...

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

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

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

RIVANNA®, developers of world-first, imaging-based medical solutions, announced they have entered into a partnership with BOMImed, a recognized manufacturer of anesthesia and critical care related consumables to represent and distribute the Accuro® portfolio of products in Canada. BOMIMED is a choice distribution partner for RIVANNA as its focus is within the fields of anesthesia and ...

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 for comprehensive ...

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

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

Augmedics, a pioneer in augmented reality surgical image guidance, announced today that it has raised $36 million in an over-subscribed Series C financing with an international syndicate of Israel-US investors. This comes only eight months after the company closed a $21 million Series B financing, bringing the total funding to date to $63 million. H.I.G. Capital, Revival Healthcare Capital, and ...

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 first Augmented Reality Guidance system to be used in surgery. It ...

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

CHICAGO--(BUSINESS WIRE)--Midwest Orthopaedics at Rush announced today that Dr. Frank Phillips, Professor and Director of the Division of Spine Surgery and the Section of Minimally Invasive Spine Surgery at Rush University Medical Center, completed the first augmented reality (AR) minimally invasive spine surgery. The Augmedics xvision™ Spine System surgical guidance system allows a surgeon ...

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

CHICAGO--(BUSINESS WIRE)--Augmedics, a pioneer in augmented reality surgical image guidance, has raised $15 million in Series B financing, led by its U.S. staff. In a nearly unprecedented move, the company’s employees formed limited liability company AUG Management LLC to raise $4 million in an effort to secure and successfully launch the company as venture capital (VC) all but evaporated ...

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 Augmented Reality Guidance system for surgery, allows surgeons to visualize ...

ByAugmedics

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