Intraoperative Imaging Articles & Analysis
23 news found
OnLume has received 510(k) clearance from the U.S. Food & Drug Administration (“FDA”) to market its first product, a fluorescence guided surgery (FGS) system. The OnLume Imaging System is indicated for fluorescence imaging of blood flow and tissue perfusion before, during, and after vascular, gastrointestinal, organ transplant, plastic, reconstructive, and micro surgeries. This ...
OnLume Inc., an early stage medical imaging company with unique technology for improving surgical precision, has been awarded a substantial grant from the U.S. National Institutes of Health (NIH)’s National Cancer Institute (NCI) to advance development of its proprietary device for Fluorescence-Guided Surgery (FGS). OnLume has developed novel FGS imaging technology to illuminate critical ...
BOSTON — May 24, 2022 — Activ Surgical™, a digital surgery pioneer, today announced the successful completion of an Institutional Review Board (IRB) study using its ActivSight™ intraoperative imaging module at the Jacobs School of Medicine and Biomedical Sciences at the University at Buffalo (UB) in New York. The 40-patient study was led by principal investigator Dr. ...
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 ...
Today marks yet another milestone in Activ Surgical’s history as we announce that the company was issued its third patent from the United States Patent and Trademark Office (USPTO) for our ActivSightTM interoperable imaging module. The ActivSight module is designed to interface with existing vision systems to enable surgeons to view in real-time critical physiological structures and ...
Ambareen Sheriff appointed as Vice President, Regulatory and Quality and Robin Stevens appointed as Non-Executive Director Novel, best-in-class agent for visualizing breast cancer margins to enter Phase III trial in 1H22 SAN DIEGO, CA – Avelas Biosciences, Inc. (“Avelas” or “the Company”), a clinical-stage drug-device company pioneering the field of fluorescence ...
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 ...
OrthoGrid® Systems, Inc, a global medtech leader on a mission to digitally transform intraoperative musculoskeletal surgery, announces the launch of ts new OrthoGrid Hip Preservation Application after receiving FDA clearance on February 18, 2021. The OrthoGrid Hip Preservation App is the latest version of OrthoGrid’s patented, distortion correcting, intraoperative-alignment technology ...
Alume Biosciences, Inc., a clinical stage biotechnology company developing nerve-targeted pharmaceuticals for surgical and therapeutic use, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its lead compound ALM-488. ALM-488 is an investigational fluorescently labelled nerve targeting pharmaceutical being developed as an adjunct for the ...
OrthoGrid® Systems, Inc., a global medtech leader on a mission to digitally transform intraoperative musculoskeletal surgery, announces the launch of its new OrthoGrid Hip software application after receiving FDA clearance on February 18, 2021. The new OrthoGrid Hip is the latest version of OrthoGrid System’s patented, distortion-correcting, implant-agnostic, intraoperative-alignment ...
Gières (Grenoble), France, January 19, 2021 - eCential Robotics, a French growth company that designs and produces the only system fully unifying 2D/3D robotic imaging and surgical navigation, and previously known as Surgivisio, today announced the rebranding of its identity. The rebranding contributes to the strengthening of the Grenoble-based company's position as a rising player in ...
SAN DIEGO, CA – Avelas Biosciences, Inc., pioneering the field of intraoperative fluorescent cancer imaging, today announced that the company has received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for pegloprastide (AVB-620) for the intraoperative detection and visualization of positive margins during breast cancer surgery. Pegloprastide is designed ...
Use of pegloprastide, a fluorescent cancer marker, during surgery correctly identified cancer in up to 75% of patients who may have otherwise been candidates for a repeat (re-excision) surgery Observed re-excision rate was ~6% in patients whose surgeries included pegloprastide; current re-excision rates are estimated at 20-40% among all patients receiving an initial lumpectomy Each year in the ...
NEW YORK— JULY 16, 2020 — Ambra Health, makers of the leading cloud-based, medical image management suite and Invenio Imaging, a leader in rapid intraoperative tissue imaging with Stimulated Raman Histology (SRH), today announced a partnership that integrates Ambra’s image management technology with Invenio’s NIO Laser Imaging System. The collaboration enables pathologists ...
Announced today, nView medical, a leading innovator in 3D medical imaging, and OrthoGrid Systems, Inc., a global MedTech leader offering intraoperative alignment technologies, are partnering to provide integrated solutions that increase surgical accuracy OR efficiency and improve patient outcomes As the first step for implementation, the companies are executing a proof of concept for a ...
Tomosynthesis imaging is a critical technology in the treatment of breast cancer and 3-D intraoperative specimen imaging is state-of-the art. The MOZART® System from KUBTEC Medical Imaging stands alone as it identifies the exact location of three dimensional objects such as tumors and localization devices inside breast cancer specimens. The VeraForm adaptable tissue marker is a radiopaque, ...
To help neurosurgeons diagnose brain tumors more efficiently, researchers from the University of Michigan developed a deep learning-based imaging technique that can reduce the tumor diagnosis process during surgery from 30-40 minutes to less than three minutes. First unveiled in 2017, the technique called stimulated Rama histology (SRH) helps neurosurgeons more rapidly assess tumor tissue in ...
SurgiMab, a late-stage biotechnology company pioneering a new antibody-based fluorescence-guided approach with the aim to improve cancer surgery and clinical outcomes for patients, today announces that the first US patient has been recruited into its on-going pivotal Phase 3 clinical trial evaluating its investigational imaging agent SGM-101 in patients undergoing colorectal cancer (CRC) surgery. ...
BySurgiMab
Epica International Inc. (Epica), received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its SeeFactorCT3 Imaging Platform. SeeFactorCT3 consists of 3 integrated imaging systems: CT, Fluoroscopy and Digital Radiography; a detachable patient table/chair, and sterile drape for interventional procedures. FDA clearance allows Epica to market these products in the United ...
SurgiMab, a late-stage biotechnology company pioneering a new antibody-based fluorescence-guided approach designed to improve cancer surgery and clinical outcomes for patients, today announces that the first surgical procedure was carried out in a pivotal Phase 3 clinical trial of the Company's lead product, SGM-101, in a patient with colorectal cancer (CRC). SGM-101 is a tumor-specific antibody ...
BySurgiMab