reconstructive surgery News
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Onlume Receives FDA 510(k) Clearance for Fluorescence-guided Surgery Device
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 ...
By OnLume Inc.
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FDA clears Sonavex’s ultrasound blood flow monitor
Sonavex scored FDA clearance for its technology that uses ultrasound imaging and deep learning to deliver blood flow data on demand. The EchoSure system is cleared for use with the company’s EchoMark bioresorbable tissue markers, which got the agency’s nod in June. “The key goal is to be able to detect the problems associated with microvascular and vascular surgeries with ...
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Renishaw hosts UK Prime Minister and Chancellor of the Exchequer for visit focused on research and development
The Prime Minister Theresa May and Chancellor of the Exchequer Philip Hammond visited Renishaw's headquarters site near Wotton-under-Edge in Gloucestershire, yesterday (24th November) for a tour of the company's main research and development (R&D) facilities. Following a meeting with senior Renishaw directors, the Prime Minister and Chancellor of the Exchequer toured the company's Innovation ...
By Renishaw plc
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Endomedix, Inc. to Present at Upcoming Society For Biomaterials 2019 Annual Meeting
Endomedix, Inc., a developer of unique biosurgical products based on natural biopolymer systems, today announced it will provide the first public presentation of its work at a scientific meeting. The 2019 Annual Meeting is scheduled for April 3-6 in Seattle, Washington. The presentation will provide data and descriptions of the performance of its patented hydrogel biomaterial in a series of ...
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Agreement signed with TELA Bio Inc
Next Science Limited (ASX:NXS) (Next Science) is pleased to announce that it has signed a multi-year distribution agreement with NASDAQ listed medical technology company, TELA Bio, Inc in relation to the supply of a white labelled version of Next Science’s proprietary XPERIENCETM No Rinse Antimicrobial Solution. The new agreement grants TELA Bio, Inc exclusive rights across the US plastic ...
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Checkpoint Surgical Enrolls First Patient in Nerve Regeneration Clinical Study
Checkpoint Surgical, Inc., the leader in intraoperative nerve repair stimulation technology, today announced it has enrolled the first patient in its multi-center clinical study of the company’s breakthrough nerve regeneration technology. The patient was enrolled at The Ohio State University, one of four sites actively enrolling patients in the double-blind, randomized clinical trial. Other ...
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New Clinical Data Supports the Use of OrthoGrid System, Inc.`s Analog and Digital Technology for Orthopedic Surgery
OrthoGrid® Systems, Inc., a global medtech leader on a mission to digitally transform intraoperative musculoskeletal surgery, announces the publication of new clinical data supporting the use of its analog and digital technology in the Journal of Arthroplasty (JOA). The article, entitled “Comparison of Component Placement Accuracy Using Two Intraoperative Fluoroscopic Grid Technologies ...
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Asensus Surgical Announces FDA Clearance in General Surgery
Asensus Surgical, Inc. (formerly TransEnterix, Inc.) (NYSE American: TRXC) , a medical device company that is digitizing the interface between the surgeon and patient to pioneer a new era of Performance-Guided Surgery™, today announced the Company has received an additional FDA clearance for the Senhance Surgical System which allows for indication expansion in general surgery in the United ...
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Medical Microinstruments’ Symani Surgical System Saves Patient’s Arm from Amputation
CALCl, Italy, July 13, 2021- Medical Microinstruments (MMI) SpA, a robotics company dedicated to improving clinical outcomes for patients undergoing microsurgery, announced today that MMI's Symani® Surgical System was successfully used at Careggi University Hospital Florence by Prof. Marco Innocenti and his team in a complex, post-traumatic limb reconstruction that saved a patient's arm from ...
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UChicago Medicine Enrolling Patients in Lymphbridge Clinical Study for Surgical Treatment of Breast Cancer-Related Lymphedema
The University of Chicago Medicine has announced today that it is now enrolling patients into LymphBridge, a randomized clinical study to evaluate a novel investigational surgical device for the treatment of breast cancer-related lymphedema. This study is sponsored by Fibralign Corporation with funding provided by the National Cancer Institute (NCI) and being led by world-renowned microsurgeon ...
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BioAesthetics Accelerates Growth with Research Breakthrough and Regional Expansion
BioAesthetics Corporation, a company transforming plastic and reconstructive surgeries through regenerative medicine, closed a financing round led by Silicon Valley-based Hemi Ventures. Investors included San Francisco’s IndieBio, the world’s largest biotech accelerator, the New Orleans BioFund, and the New Orleans Startup Fund. “We’re tremendously excited to join the ...
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Sofregen Receives 510(k) Clearance for Silk Voice - The First and Only Natural Silk Protein Injectable Product for Tissue Bulking
Sofregen Medical, Inc. (Sofregen), an early stage commercial biotechnology company developing products for medical aesthetics and reconstructive surgery, announced today that Silk Voice has been cleared by the U.S. Food and Drug Administration (FDA) for augmenting vocal fold tissue for phonation improvement. This is the first and only FDA cleared product made from solubilized silk protein and is ...
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Poietis and Assistance Publique – Hôpitaux de Marseille (AP-HM) annouce the first installation of a 3D bioprinting platform for manufacturing implantable biological tissues in hospitals
The installation of the NGB (Next-Generation Bioprinting) robotic bioprinting platform developed by Poietis in the Advanced Therapy Medicinal Product (ATMP) manufacturing area of the Hôpital de la Conception represents a world premiere and opens up very promising perspectives in regenerative medicine. The objective is now to start the first clinical trial of a 3D printed ...
By Poietis
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Preliminary Data Presented from First U.S. Clinical Trial of IlluminOss Medical`s Photodynamic Bone Stabilization System
IlluminOss Medical, a privately-held, commercial stage medical device company focused on minimally invasive orthopedic fracture repair, today announced that Richard Terek, M.D., presented the first preliminary data from its U.S. pivotal clinical trial at the recent Musculoskeletal Tumor Society (MSTS) Meeting in Detroit. The IlluminOss System is the world’s only system of its kind which ...
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BioAesthetics Announces University Clinical Study for its Nipple Reconstruction Graft
BioAesthetics Corporation today announced a clinical study of its nipple reconstruction graft will be performed at Stanford Medicine beginning in 2021. The BioAesthetics® NACgraft™ biologic matrix is a decellularized skin allograft of the human nipple-areolar complex (NAC) intended to replace the NAC when lost due to mastectomy or other procedure. BioAesthetics hopes the NACgraft will ...
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Ankasa Regenerative Therapeutics Receives $8.5 Million in First Tranche of $17 Million Series A Financing Led by Avalon Ventures
Ankasa Regenerative Therapeutics, Inc. (Ankasa), a company focused on pharmaceutical preparations for reactivation of stem cells for organ and tissue regrowth, tissue repair and healing, has received $8.5 million in the first tranche of a $17 million Series A round of financing led by La Jolla-based Avalon Ventures. Other participants in the financing include Heraeus Medical, a global business ...
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FDA approves Sonavex`s EchoSure system
The FDA has granted its seal of approval to Sonavex to begin shipping its EchoSure system to providers across the U.S. A combination of 3D ultrasound imaging and advanced deep learning algorithms, the device automates visual and quantitative analysis to monitor and provide up-to-date information on blood flow following surgical procedures. “Doppler ultrasound is an accurate imaging ...
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CMR Surgical & Surgical Innovations develop new surgical hybrid port access system
CMR Surgical & Surgical Innovations develop new surgical hybrid port access system Surgical Innovations’ new YelloPort Elite™ 5mm, with reusable trocar and canula, reduces cost and waste generated when compared with traditional fully single use Port Access Systems Developed with CMR Surgical, the port access system is the latest addition to Surgical Innovation’s ...
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Alume Biosciences Granted FDA Fast Track Designation of ALM-488 for Surgical Nerve Visualization
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 ...
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Lattice Medical announces the closing of a €8 million Series A financing round
LATTICE MEDICAL, announces the closing of a second round of financing of 8 million euros. This round was led by the historical funds Finovam Gestion, Nord France Amorçage and WiSEED alongside the Captech Santé fund. The European Commission, via its EIC Fund, and Santelys are co-investing. The financing round is completed by non-dilutive financing, in the form of a grant and debt ...
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