Spine

Accelus Introduces LineSider Modular-Cortical System for Posterior Fixation

Retrieved on: 
Monday, January 29, 2024

This expansion to Accelus’s LineSider Spinal System product portfolio is designed to meet the needs of surgeons who use a modular pedicle screw system from either a standard open approach or a medial-to-lateral cortical approach.

Key Points: 
  • This expansion to Accelus’s LineSider Spinal System product portfolio is designed to meet the needs of surgeons who use a modular pedicle screw system from either a standard open approach or a medial-to-lateral cortical approach.
  • “I highly recommend utilizing the LineSider Modular-Cortical System to complement the FlareHawk expandable interbody fusion device,” said Dr. Ryan Martyn, orthopedic spine surgeon at Spine Colorado.
  • The LineSider Modular-Cortical System builds on Accelus's legacy of developing adaptable, surgeon-centric solutions.
  • "The LineSider Modular-Cortical System exemplifies our commitment to elevating the surgical experience and improving patient outcomes,” said Accelus President and Chief Executive Officer Kevin McGann.

ClearPoint Neuro Announces Installation and First Procedure Using the ClearPoint Prism® Neuro Laser Therapy System and Navigation System at Kaleida Health in Buffalo

Retrieved on: 
Wednesday, January 24, 2024

SOLANA BEACH, Calif., Jan. 24, 2024 (GLOBE NEWSWIRE) -- ClearPoint Neuro, Inc. (Nasdaq: CLPT) (the “Company”), a global device, cell, and gene therapy-enabling company offering precise navigation to the brain and spine, today announced installation and completion of an initial procedure with both the ClearPoint Prism Neuro Laser Therapy System and the ClearPoint Neuro Navigation System by Dr. Jonathan Riley and team at Kaleida Health in Buffalo, New York.

Key Points: 
  • SOLANA BEACH, Calif., Jan. 24, 2024 (GLOBE NEWSWIRE) -- ClearPoint Neuro, Inc. (Nasdaq: CLPT) (the “Company”), a global device, cell, and gene therapy-enabling company offering precise navigation to the brain and spine, today announced installation and completion of an initial procedure with both the ClearPoint Prism Neuro Laser Therapy System and the ClearPoint Neuro Navigation System by Dr. Jonathan Riley and team at Kaleida Health in Buffalo, New York.
  • “We are ecstatic to have completed our first successful case with combined ClearPoint Neuro MRI targeting and laser ablation solutions,” stated Dr. Jonathan Riley, Assistant Professor of Neurosurgery at the University of Buffalo, and Medical Director of Functional Neurosurgery at Kaleida Health.
  • We look forward to continued success together with the team at Kaleida Health and as we look to expand into full market release later this year.”
    The ClearPoint Prism Neuro Laser Therapy System features the only non-cooled laser applicator on the market.
  • For more information about the ClearPoint Neuro Laser Therapy System please visit: https://www.clearpointneuro.com/clearpoint-prism-neuro-laser-system/

ClearPoint Neuro Announces First EU MDR Certification Success and Approval to Ship Product to Europe

Retrieved on: 
Monday, January 22, 2024

Additionally, the Company received updated certification from its Notified Body allowing for shipment of products manufactured at its new Carlsbad, California facility to Europe.

Key Points: 
  • Additionally, the Company received updated certification from its Notified Body allowing for shipment of products manufactured at its new Carlsbad, California facility to Europe.
  • European Medical Device Regulation 2017/745 (EU MDR), the new medical device regulation applicable in Europe, replaces the previous Medical Device Directive 93/42/EEC (MDD) regulation.
  • With the introduction of EU MDR, the EU is placing greater emphasis on safety measures, risk management, post-market surveillance, and data collection of medical devices for companies who wish to obtain European market access.
  • “Our team has risen to this challenge, especially given the importance of the EU to our pharmaceutical partners.”

Aclarion Expands Nociscan Access Into Phoenix With Key Opinion Leader Surgeon Advisor Juan Uribe, MD

Retrieved on: 
Monday, January 22, 2024

BROOMFIELD, CO, Jan. 22, 2024 (GLOBE NEWSWIRE) -- via NewMediaWire –  Aclarion, Inc. (“Aclarion” or the “Company”) (Nasdaq: ACON, ACONW), a healthcare technology company that is leveraging biomarkers and proprietary augmented intelligence algorithms to help physicians identify the location of chronic low back pain, announced today that Nociscan is now available in the greater Phoenix, AZ market at the Barrow Neurological Institute with Dr. Juan Uribe and other area physicians treating chronic low back pain.

Key Points: 
  • Dr. Uribe's practice emphasizes a comprehensive approach to treating the spine and applying minimally invasive spine surgery to complex degenerative disease.
  • Low back pain is an extremely debilitating condition that lacks a noninvasive tool helping me identify the location of a patient's pain.
  • Uribe is a renowned neurosurgeon at one of the world’s leading neurological institutes, Barrow,” said Ryan Bond, Chief Strategy Officer of Aclarion.
  • For information about Nociscan use in Phoenix, please contact Aclarion at [email protected] .

ONWARD® Announces Start of HemON NL Clinical Study

Retrieved on: 
Thursday, January 18, 2024

EINDHOVEN, the Netherlands, Jan. 18, 2024 (GLOBE NEWSWIRE) -- ONWARD Medical N.V. (Euronext: ONWD), the medical technology company creating innovative spinal cord stimulation therapies to restore movement, function, and independence in people with spinal cord injury (SCI), today announces the start of the HemON NL clinical feasibility study at Sint Maartenskliniek in Nijmegen, the Netherlands.

Key Points: 
  • EINDHOVEN, the Netherlands, Jan. 18, 2024 (GLOBE NEWSWIRE) -- ONWARD Medical N.V. (Euronext: ONWD), the medical technology company creating innovative spinal cord stimulation therapies to restore movement, function, and independence in people with spinal cord injury (SCI), today announces the start of the HemON NL clinical feasibility study at Sint Maartenskliniek in Nijmegen, the Netherlands.
  • The surgery was performed by neurosurgeon Erkan Kurt, MD at Radboud University Medical Center, which has a neurosurgery department affiliated with Sint Maartenskliniek.
  • Building on the Swiss HemON clinical feasibility study, HemON NL prepares the Company for expected initiation of a global pivotal trial, called Empower BP, which is designed to provide the evidence necessary to submit a pre-market approval (PMA) to the US Food and Drug Administration (FDA) and other global regulatory authorities.
  • The Company plans to enroll participants in both HemON and HemON NL as it finalizes the design of the Empower BP pivotal study.

Endologix Announces that Art Taylor Joins Board of Directors

Retrieved on: 
Thursday, January 25, 2024

Endologix LLC , a privately held, global medical device company dedicated to providing disruptive therapies for the interventional treatment of vascular disease, is pleased to announce that Art Taylor has been appointed to the Endologix Board of Directors.

Key Points: 
  • Endologix LLC , a privately held, global medical device company dedicated to providing disruptive therapies for the interventional treatment of vascular disease, is pleased to announce that Art Taylor has been appointed to the Endologix Board of Directors.
  • Art Taylor has over 30 years of experience in operational and financial executive leadership within the medical device, pharmaceutical, and high-tech industries.
  • Mr. Taylor served as a member of the Board of Directors for several medical device firms that were subsequently acquired and is currently a Board member for three early stage companies, and Providence Medical Technology, a commercial stage company.
  • "We are excited to welcome Art Taylor to the Endologix Board of Directors," expressed Matt Thompson, MD, President, and CEO of Endologix.

MTF Biologics Awards 2023 Grants for Innovation in Allograft Translational Research

Retrieved on: 
Monday, January 22, 2024

“MTF Biologics is proud of our long-standing commitment to supporting the scientific and patient communities through our allograft innovation grants,” said Joe Yaccarino, President and CEO of MTF Biologics.

Key Points: 
  • “MTF Biologics is proud of our long-standing commitment to supporting the scientific and patient communities through our allograft innovation grants,” said Joe Yaccarino, President and CEO of MTF Biologics.
  • “These grants advance the science of allograft tissue transportation and support MTF Biologics’ dedication to saving and healing lives.
  • We congratulate all of this year's recipients and look forward to the results of their crucial work which will positively impact lives around the world.”
    Innovation in Allograft Translational Research Grants fund translational and clinical research in the fields of allograft transplantation and allograft science.
  • Hans Burchardt Impact Awardee” for the awarded grant with the highest potential clinical impact.”
    Letters of Intent are now being accepted for the 2024 MTF Biologics Innovation in Allograft Translational Research Grants Program.

ChoiceSpine LLC Announces Changes in Leadership Roles

Retrieved on: 
Thursday, January 18, 2024

ChoiceSpine LLC, a medical device company in Knoxville, Tennessee, and privately held by Altus Capital Partners, announces that Marty Altshuler and Rick Henson, founders and Co-Presidents of ChoiceSpine, transitioned to Executive Advisor roles following 18 years of leading the company.

Key Points: 
  • ChoiceSpine LLC, a medical device company in Knoxville, Tennessee, and privately held by Altus Capital Partners, announces that Marty Altshuler and Rick Henson, founders and Co-Presidents of ChoiceSpine, transitioned to Executive Advisor roles following 18 years of leading the company.
  • Conjointly, effective January 01, 2024, the Board of Directors for ChoiceSpine, LLC selected Stephen Ainsworth, Executive Vice President of Strategy and Technology, and Andy Broyles, Chief Financial Officer, to succeed Mr. Altshuler and Mr. Henson as Co-Presidents of ChoiceSpine.
  • Mr. Altshuler and Mr. Henson will remain with ChoiceSpine, serving on the Board of Directors and as advisors to the Executive Team.
  • This strategic move is poised to enhance the company's innovative edge and continued growth in the spine market.

Orthofix Announces Commercial Partnership with MRIguidance

Retrieved on: 
Thursday, January 18, 2024

(NASDAQ:OFIX), a leading global spine and orthopedics company, today announced it has entered into an agreement with MRIguidance to distribute its BoneMRI™ imaging software in the U.S.

Key Points: 
  • (NASDAQ:OFIX), a leading global spine and orthopedics company, today announced it has entered into an agreement with MRIguidance to distribute its BoneMRI™ imaging software in the U.S.
  • The Company also announced the successful completion of the world’s first eight cases utilizing BoneMRI software with 7D’s FLASH™ Navigation System .
  • BoneMRI creates a synthetic CT from an MRI imaging exam without the use of harmful radiation.
  • This marks the successful start to a fruitful collaboration with Orthofix to deliver radiation-free spine surgery.”
    To learn more about the 7D FLASH Navigation System, please visit SeaSpine.com or 7DSurgical.com .

In the War on Cancer, Tampa General Hospital Cancer Institute Employs AI in its Newly Established Center for Precision Radiosurgery

Retrieved on: 
Thursday, January 25, 2024

TAMPA, Fla., Jan. 25, 2024 /PRNewswire/ -- Going under the knife is taking on a new and more promising meaning at Tampa General Hospital (TGH) Cancer Institute, where doctors are using a sophisticated AI-driven tool to treat cancer.

Key Points: 
  • TAMPA, Fla., Jan. 25, 2024 /PRNewswire/ -- Going under the knife is taking on a new and more promising meaning at Tampa General Hospital (TGH) Cancer Institute , where doctors are using a sophisticated AI-driven tool to treat cancer.
  • It is capable of treating cancerous and benign tumors throughout the body, as well as neurologic disorders, in as little as 15 minutes.
  • The tool, through its speed and advanced precision, is expected to expand the capabilities of Tampa General Cancer Institute's newly established Center for Precision Radiosurgery, said Dr. Richard Tuli, professor and chair of the Department of Radiation Oncology at USF Health Morsani College of Medicine, deputy director of the TGH Cancer Institute, and director of Radiation Oncology at Tampa General.
  • Tuli joined TGH from Memorial Sloan Kettering Cancer Center in New York, N.Y.
    "It's another example of providing our patients with the best possible care across the Tampa Bay region and the state,'' he said.