Neurosurgery

Zeta Surgical's Mixed Reality Navigation System Receives FDA Special 510(k) Clearance for Expanded Functionality

Retrieved on: 
Thursday, January 11, 2024

BOSTON, Jan. 11, 2024 /PRNewswire/ -- Zeta Surgical, a surgical robotics and mixed reality company, announced today that its Zeta Cranial Navigation System has received Special 510(k) clearance from the U.S. Food and Drug Administration (FDA) for expanded functionality through enhanced software features and compatibility with additional accessories.

Key Points: 
  • BOSTON, Jan. 11, 2024 /PRNewswire/ -- Zeta Surgical, a surgical robotics and mixed reality company, announced today that its Zeta Cranial Navigation System has received Special 510(k) clearance from the U.S. Food and Drug Administration (FDA) for expanded functionality through enhanced software features and compatibility with additional accessories.
  • The Zeta Cranial Navigation System is a mixed-reality navigation system for neurosurgery, providing surgeons with "GPS-like" guidance with millimetric accuracy in real-time.
  • The platform received its first 510(k) clearance from the U.S. FDA in September 2023.
  • "We are thrilled to scale Zeta's deployments in the U.S., building on its early successes in clinics," said Jose Amich, Co-Founder and CEO of Zeta Surgical.

OCUTRX Debuts Latest AR/XR Vision Headset at CES 2024: Revealing Expanded Uses, Surging Global Interest, and New Pre-Order Opportunities

Retrieved on: 
Tuesday, January 9, 2024

Ocutrx's OcuLenz, an innovative AR/XR headset, is engineered to address advanced macular degeneration (AMD), the leading cause of vision loss among adults over 65 .

Key Points: 
  • Ocutrx's OcuLenz, an innovative AR/XR headset, is engineered to address advanced macular degeneration (AMD), the leading cause of vision loss among adults over 65 .
  • Using advanced pixel manipulation, it overlays high-contrast images onto the user's field of view, compensating for AMD's central vision loss by shifting images to the peripheral vision.
  • Ocutrx invites attendees of the CES ShowStoppers event tonight to visit their booth for an exclusive live demonstration of the OcuLenz headset.
  • Additionally, to access our comprehensive press kit, which includes further insights and visuals on the OcuLenz headset, see our dedicated press kit .

Calidi Biotherapeutics Announces the Appointment of Three New Members to its Scientific and Medical Advisory Board

Retrieved on: 
Monday, January 8, 2024

Calidi Biotherapeutics, Inc. (NYSE American: CLDI or “Calidi”), a clinical-stage biotechnology company developing a new generation of targeted immunotherapies today announced the appointment of three new members to its Scientific and Medical Advisory Board.

Key Points: 
  • Calidi Biotherapeutics, Inc. (NYSE American: CLDI or “Calidi”), a clinical-stage biotechnology company developing a new generation of targeted immunotherapies today announced the appointment of three new members to its Scientific and Medical Advisory Board.
  • “Calidi continues to expand our Scientific and Medical Advisory Board, adding leading physicians and scientists from the top cancer hospitals and research institutions in the United States,” said Allan Camaisa, CEO and Chairman of the Board of Calidi Biotherapeutics.
  • Dr. Chiocca is a faculty member at Harvard Medical School and leads a laboratory focused on developing novel genetic therapies for malignant brain tumors.
  • from the University of Tennessee and completed his residency and fellowship at UAB Hospital in Neurology and Neuro-oncology.

Axogen Announces Promotions on Research and Development Team

Retrieved on: 
Thursday, January 4, 2024

ALACHUA, Fla. and TAMPA, Fla., Jan. 04, 2024 (GLOBE NEWSWIRE) --  Axogen, Inc. (NASDAQ: AXGN), a global leader in developing and marketing innovative surgical solutions for peripheral nerve injuries, today announced the promotions of three research and development team members.

Key Points: 
  • ALACHUA, Fla. and TAMPA, Fla., Jan. 04, 2024 (GLOBE NEWSWIRE) --  Axogen, Inc. (NASDAQ: AXGN), a global leader in developing and marketing innovative surgical solutions for peripheral nerve injuries, today announced the promotions of three research and development team members.
  • The promotions are:
    Mr. DeVinney joined Axogen in April of 2007 as Director of Clinical Research.
  • During his tenure, he has held positions of progressive responsibility in Clinical Research, Research and Development, Product Development, Medical Education, and Medical Affairs.
  • He has a diverse background, including academic research and the development of tissue technologies, medical devices, pharmaceuticals, and biologics.

RespireRx Pharmaceuticals Inc. Announces the Publication of a Case Report in which KRM-II-81 Totally Suppressed Epileptiform Activity in Brain Tissue Surgically Removed from Epileptic Patient

Retrieved on: 
Thursday, January 4, 2024

Cortical brain tissue surgically resected from the patient exhibited epileptiform bursting with microelectrode recordings.

Key Points: 
  • Cortical brain tissue surgically resected from the patient exhibited epileptiform bursting with microelectrode recordings.
  • When KRM–II–81, one of our lead GABAkines, was added the incubation fluid, the epileptiform activity in the excised brain tissue was fully suppressed.
  • Although our research team has observed suppression of activity previously in cortical tissue from epileptic patients, we have now observed recurrent epileptiform bursting in this patient’s tissue.
  • KRM-II-81 fully suppressed the epileptiform bursting, which returned when KRM-II-81 was removed from the incubation medium.

BAPTIST HEALTH AND COMPASS SURGICAL PARTNERS ANNOUNCE JOINT VENTURE TO EXPAND AMBULATORY SURGICAL CARE IN NORTHEAST FLORIDA

Retrieved on: 
Thursday, January 4, 2024

JACKSONVILLE, Fla. and RALEIGH, N.C., Jan. 4, 2024 /PRNewswire/ -- Baptist Health, a faith-based, mission-driven health system in Northeast Florida, and Compass Surgical Partners, an independent, full-service ambulatory surgery center (ASC) development and management partner, today announced their plans to jointly launch a network of ASCs branded as Horizon Surgery Center. The first of these projects is located on the campus of Baptist Medical Center Beaches in Jacksonville, Fla., slated to open in early 2024. Moving forward, Baptist Health and Compass Surgical Partners have plans to open multiple Horizon Surgery Center facilities in Northeast Florida, both by modernizing outpatient spaces owned by the health system and making targeted acquisitions of existing ASCs. Horizon Surgery Center Beaches will offer outpatient procedures across a range of surgical specialties including orthopedics, neurosurgery, plastics and general surgery.

Key Points: 
  • Moving forward, Baptist Health and Compass Surgical Partners have plans to open multiple Horizon Surgery Center facilities in Northeast Florida, both by modernizing outpatient spaces owned by the health system and making targeted acquisitions of existing ASCs.
  • Horizon Surgery Center Beaches will offer outpatient procedures across a range of surgical specialties including orthopedics, neurosurgery, plastics and general surgery.
  • "By working together with Compass, we aim to make excellent outpatient surgical care even more affordable and accessible to our growing community.
  • "Compass Surgical Partners is proud to engage in this joint venture with Baptist Health as it addresses its community's need for broader access to advanced surgical care," said Compass Surgical Partners CEO DJ Hill.

Accarent Health Announces Affiliation with Children’s Hospital Los Angeles to Provide Virtual Cardiology, Oncology and Musculoskeletal Second Opinion Services

Retrieved on: 
Tuesday, January 2, 2024

Children’s Hospital Los Angeles (CHLA) provides exceptional family-centered care and life-saving treatments delivered by renowned physicians, surgeons, nurses and technicians in a child-friendly environment.

Key Points: 
  • Children’s Hospital Los Angeles (CHLA) provides exceptional family-centered care and life-saving treatments delivered by renowned physicians, surgeons, nurses and technicians in a child-friendly environment.
  • CHLA has also developed multiple surgical episodes of care for cardiovascular, musculoskeletal disorders, neurologic conditions and gene replacement therapy to support their second opinion services.
  • Accarent Health connects employers, patients, and plan administrators to a network of top-rated medical centers for superior, cost-effective care.
  • Employers interested in adopting a value-based health care system can learn more about Accarent Health at www.accarenthealth.com.

NeuroOne® Reports Fiscal Fourth Quarter and Full Fiscal Year 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Thursday, December 14, 2023

The Company had no collaboration revenue in the fourth quarter of fiscal 2023 and $1,455,000 for the full year of fiscal 2023, compared to collaboration revenue of $1,942,000 in the fourth quarter and $1,949,000 for the full year of fiscal 2022.

Key Points: 
  • The Company had no collaboration revenue in the fourth quarter of fiscal 2023 and $1,455,000 for the full year of fiscal 2023, compared to collaboration revenue of $1,942,000 in the fourth quarter and $1,949,000 for the full year of fiscal 2022.
  • Total operating expenses in the fourth quarter of fiscal 2023 were $3.4 million, compared with $3.3 million in the same period of the prior year.
  • R&D expense in the fourth quarter of fiscal 2023 was $1.8 million compared with $1.4 million in the same period of fiscal 2022.
  • SG&A expense in the fourth quarter of fiscal 2023 was $1.6 million compared with $1.9 million in the same period of the prior year.

Integra LifeSciences Announces Definitive Agreement to Acquire Acclarent®

Retrieved on: 
Wednesday, December 13, 2023

Acclarent is an innovator and market leader in ENT procedures and upon closing, Integra will be one of the leading providers of ENT products and technologies.

Key Points: 
  • Acclarent is an innovator and market leader in ENT procedures and upon closing, Integra will be one of the leading providers of ENT products and technologies.
  • “This acquisition presents Integra with a rare opportunity to become a key player in the ENT segment.
  • Acclarent’s culture of pioneering technologies aligns with Integra’s legacy of innovation to transform care and restore patients’ lives,” said Jan De Witte, president and chief executive officer of Integra LifeSciences.
  • Goldman, Sachs & Co. is serving as exclusive financial advisor and Morgan, Lewis & Bockius LLP is acting as legal advisor to Integra.

NeuroOne® Receives FDA 510(k) Clearance to Market its OneRF™ Ablation System

Retrieved on: 
Monday, December 11, 2023

EDEN PRAIRIE, Minn., Dec. 11, 2023 (GLOBE NEWSWIRE) -- NeuroOne Medical Technologies Corporation (Nasdaq: NMTC) (NeuroOne or the Company), a medical technology company focused on improving surgical care options and outcomes for patients suffering from neurological disorders, today announced that it has received U.S. Food and Drug Administration (“FDA”) 510(k) clearance to market its OneRF™ Ablation System for creation of radiofrequency (“RF”) lesions in nervous tissue for functional neurosurgical procedures.

Key Points: 
  • This may also reduce hospital stays, number of surgeries, and adverse events, while offering significant benefits from a clinical perspective.
  • The addition of temperature control at the point of ablation also may enhance patient safety.
  • The OneRF Ablation System is the Company’s first device with a therapeutic indication and its third FDA 510(k)-cleared device.
  • NeuroOne estimates the current brain ablation market to be at least $100M worldwide and growing rapidly, with the potential to grow multifold based on large addressable patient populations with unmet clinical needs.