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Gastrointestinal Surgery Articles & Analysis: Older

16 news found

Onlume Receives FDA 510(k) Clearance for Fluorescence-guided Surgery Device

Onlume Receives FDA 510(k) Clearance for Fluorescence-guided Surgery Device

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 ...

ByOnLume Inc.


Avalon Healthcare Solutions’ Client BCBS of South Carolina Adds CDx Diagnostics as In-Network Lab

Avalon Healthcare Solutions’ Client BCBS of South Carolina Adds CDx Diagnostics as In-Network Lab

CDx Diagnostics, Inc. is pleased to announce that it has signed an agreement with laboratory benefits management provider Avalon Healthcare Solutions, Inc. of Tampa, Fla. The agreement means that CDx will be an in-network specialty anatomic pathology laboratory of Avalon client BlueCross BlueShield of South Carolina, and builds on Avalon’s positive medical policy for CDx’s proprietary ...

ByCDx Diagnostics Inc.


Vedanta Presents Data from Multiple Studies at Digestive Disease Week 2022 Annual Meeting

Vedanta Presents Data from Multiple Studies at Digestive Disease Week 2022 Annual Meeting

VE202 was also well tolerated, with most adverse events unrelated to study treatment, gastrointestinal in nature, and of mild or moderate intensity. About Vedanta Biosciences Vedanta Biosciences is leading the development of a potential new category of oral therapies based on defined consortia of bacteria isolated from the human microbiome and grown from pure clonal cell banks. ...

ByVedanta Biosciences, Inc


CDx Diagnostics’ WATS3D Participates in Highmark, Inc. Health Plans in Delaware, Pennsylvania, and West Virginia

CDx Diagnostics’ WATS3D Participates in Highmark, Inc. Health Plans in Delaware, Pennsylvania, and West Virginia

WATS3D, an AI powered diagnostic platform developed by CDx Diagnostics to empower physicians to reliably detect Barrett’s esophagus (BE) and esophageal dysplasia to help prevent esophageal cancer, was designated as medically necessary by Highmark, Inc. health plans in Delaware, Pennsylvania, and West Virginia in Q4 2021. CDx Diagnostics is pleased to share, that effective immediately, ...

ByCDx Diagnostics Inc.


Palisade Bio And Newsoara Receive NMPA Clearance To Commence Phase 3 Clinical Trial In China Evaluating LB1148 To Accelerate The Return Of Bowel Function Following Abdominal Surgery

Palisade Bio And Newsoara Receive NMPA Clearance To Commence Phase 3 Clinical Trial In China Evaluating LB1148 To Accelerate The Return Of Bowel Function Following Abdominal Surgery

LB1148 is an oral formulation of a broad-spectrum serine protease inhibitor designed to neutralize the activity of potent digestive proteases released from the gut during surgery. In a previously conducted Phase 2 trial in gastrointestinal (GI) surgery, Palisade Bio and Newsoara demonstrated LB1148 had a statistically significant (p=0.0008) ...

ByPalisade Bio


Palisade Bio (Nasdaq: PALI) Announces Analysis Demonstrating LB1148 Reduced The Extent And Severity Of Post-Surgical Intraabdominal Adhesions By 93%

Palisade Bio (Nasdaq: PALI) Announces Analysis Demonstrating LB1148 Reduced The Extent And Severity Of Post-Surgical Intraabdominal Adhesions By 93%

” Studies LBS-IST-POI-101 and LBS-POI-201-CN (PROFILE-CN) assessed the efficacy of LB1148 to reduce the formation of adhesions in subjects undergoing abdominal surgery. Study LBS-IST-POI-101 was a Phase 1, single-center, open-label, study enrolling 11 subjects undergoing GI surgery. ...

ByPalisade Bio


Palisade Bio (Nasdaq: PALI) To Present New Clinical Data Of LB1148 For Preventing Adhesions In Conjunction With Next Big Thing Session At Society Of American Gastrointestinal And Endoscopic Surgeons 2022 Annual Meeting

Palisade Bio (Nasdaq: PALI) To Present New Clinical Data Of LB1148 For Preventing Adhesions In Conjunction With Next Big Thing Session At Society Of American Gastrointestinal And Endoscopic Surgeons 2022 Annual Meeting

(Nasdaq: PALI), a clinical stage biopharmaceutical company advancing therapies for acute and chronic gastrointestinal (GI) complications, was selected to present an ePoster entitled “Pooled-Analysis of Incidence and Severity of Post-Surgical Intraabdominal Adhesions following Bowel Resection Surgery and Treatment with Enteral Protease Inhibitor ...

ByPalisade Bio


University Hospitals Ventures to Expand Collaboration with Lazurite™ and Invest in the Company

University Hospitals Ventures to Expand Collaboration with Lazurite™ and Invest in the Company

Medical device and technology company Lazurite Holdings LLC today announced a new phase of collaboration with University Hospitals (UH) Ventures, the innovation and commercialization arm of University Hospitals Health System in Cleveland, which will include an investment from UH Ventures. The amount and details of the investment were not specified. This past August, Lazurite announced its ...

ByLazurite Holdings LLC.


New Research Shows Progression to Esophageal Cancer as Detected by WATS3D

New Research Shows Progression to Esophageal Cancer as Detected by WATS3D

A newly published study as lead article in Gastrointestinal Endoscopy shows that Barrett’s esophagus (BE) and dysplasia progress to esophageal cancer at similar, or even higher, rates when diagnosed by WATS3D (wide-area transepithelial sampling with three-dimensional analysis) as they do when diagnosed by conventional forceps biopsies. This study titled “Progression of ...

ByCDx Diagnostics Inc.


Lazurite™ Announces FDA 510(k) Submission for its ArthroFree™ Wireless Camera System; is Recognized by AngelMD as One of the Best Startups of 2021

Lazurite™ Announces FDA 510(k) Submission for its ArthroFree™ Wireless Camera System; is Recognized by AngelMD as One of the Best Startups of 2021

Food and Drug Administration (FDA) for its ArthroFree™ wireless camera system for minimally invasive surgery, and that the submission has been accepted for review. The company also announced that early-stage healthcare investment platform AngelMD named it one of the best startup companies of 2021. ...

ByLazurite Holdings LLC.


Medical Device Company Lazurite™ Named a 2021 Top 10 Endoscopy Device Provider by MedTech Outlook Magazine

Medical Device Company Lazurite™ Named a 2021 Top 10 Endoscopy Device Provider by MedTech Outlook Magazine

Medical device and technology company Lazurite Holdings LLC has been recognized by MedTech Outlook magazine as a 2021 Top 10 Endoscopy Device Provider for its ArthroFree™ wireless camera system for minimally invasive surgery. MedTech Outlook describes itself as a platform that bridges the spectrum between medtech technology providers and healthcare facilities and medical ...

ByLazurite Holdings LLC.


CDx Diagnostics’ WATS3D Receives “Medically Necessary” Designation from Highmark Health Plans

CDx Diagnostics’ WATS3D Receives “Medically Necessary” Designation from Highmark Health Plans

WATS3D, a diagnostic platform developed by CDx Diagnostics to empower physicians to detect Barrett’s esophagus (BE) and esophageal dysplasia, has been designated as medically necessary by Highmark Blue Cross Blue Shield plans in Delaware, Pennsylvania, and West Virginia. Clinically proven to significantly increase the detection rate of BE, pre-cancer, and cancerous cells in the esophagus ...

ByCDx Diagnostics Inc.


Activ Surgical Completes First In-Human Procedures to Demonstrate Impact of its Surgical Intelligence and Sensing Platform

Activ Surgical Completes First In-Human Procedures to Demonstrate Impact of its Surgical Intelligence and Sensing Platform

BOSTON — November 3, 2021 — Activ Surgical™, a digital surgery pioneer, today announced the completion of its first in-human surgery clinical trial utilizing the company’s technology-as-a-service bundle—the ActivInsights™ augment reality (AR)-based software suite and the ActivSight™ imaging module. ...

ByActiv Surgical, Inc.


Asensus Surgical Announces Shinmatsudo Central General Hospital in Japan to Initiate Senhance Robotic Surgical System

Asensus Surgical Announces Shinmatsudo Central General Hospital in Japan to Initiate Senhance Robotic Surgical System

The hospital’s surgical department offers a wide range of surgical specialities, with a focus on cardiovascular and gastrointestinal surgery, where it employs a variety of surgical solutions including open, laparoscopic, and robotically assisted procedures. ...

ByAsensus Surgical US, Inc.


Lumendi Receives 510(K) Clearance for Dilumen Ik Endolumenal Interventional Knife

Lumendi Receives 510(K) Clearance for Dilumen Ik Endolumenal Interventional Knife

These new Endolumenal Interventional Instruments are based on Lumendi’s initiative to improve access and tissue manipulation in the colon to help move many gastrointestinal surgeries to less invasive endolumenal procedures. The DiLumen™ EIP consists of a single-use, soft flexible sheath that fits over standard and small-diameter endoscopes. ...

ByLumendi Ltd.


SAFEHEAL starts first-in-human and CE-mark clinical study of endoluminal bypass sheath with the potential of replacing ostomy

SAFEHEAL starts first-in-human and CE-mark clinical study of endoluminal bypass sheath with the potential of replacing ostomy

Jan 29, 2018 – The study will evaluate safety and efficacy of the Colovac bypass device for ostomy-free anastomosis protection following colorectal surgery SafeHeal, a leading innovator in the field of digestive surgery and developer of the Colovac device, announces today that it has enrolled the first five patients in its CE mark ...

BySafeHeal

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