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30 news found

ImmunogenX and Mayo Clinic Celiac Disease Study Published in Gastroenterology

ImmunogenX and Mayo Clinic Celiac Disease Study Published in Gastroenterology

ImmunogenX is pleased to report the successful completion of the CeliacShield trial (NCT03585478), focused on treating celiac disease (CeD) patients, will be published in the premier journal Gastroenterology and is entitled: Latiglutenase Protects the Mucosa and Attenuates Symptom Severity in Patients with Celiac Disease Exposed to a Gluten Challenge doi.org/10.1053/j.gastro.2022.07.071 This ...

ByEntero Therapeutics, Inc.


Endpoint Clinical Selects Egnyte to Enhance IRT Audit Logs for Clinical Trials

Endpoint Clinical Selects Egnyte to Enhance IRT Audit Logs for Clinical Trials

Endpoint Clinical, the leader in global interactive response technology (IRT®) for clinical trials, and Egnyte, the secure platform for content collaboration and governance, today announced that Endpoint Clinical has partnered with Egnyte, providing a Google Cloud-compliant platform to establish a secure file server that can share IRT audit logs directly with Investigators ...

ByEndpoint Clinical


SIGA Provides Update on Progress in Clinical Trials to Assess Use of TPOXX ® (tecovirimat) for Treatment of Monkeypox

SIGA Provides Update on Progress in Clinical Trials to Assess Use of TPOXX ® (tecovirimat) for Treatment of Monkeypox

NEW YORK, Oct. 12, 2022 (GLOBE NEWSWIRE) -- SIGA Technologies, Inc. (SIGA) (NASDAQ: SIGA), a commercial-stage pharmaceutical company focused on the health security market, today provided an update on the status of multiple clinical trials now underway to assess the safety and efficacy of TPOXX to treat monkeypox. In recent weeks, randomized, placebo-controlled clinical trials were initiated in ...

BySIGA Technologies, Inc.


CONVERT Clinical Trial Data Presented at ERS Demonstrates Early Success of AeriSeal System in Patients with Advanced COPD/Emphysema

CONVERT Clinical Trial Data Presented at ERS Demonstrates Early Success of AeriSeal System in Patients with Advanced COPD/Emphysema

” About the CONVERT Study CONVERT is a prospective, open-label, multi-center, single-arm study being conducted at up to 20 investigational sites. The study plans to enroll 140 subjects with severe emphysema and collateral ventilation in the target lobe. ...

ByPulmonx Corporation


Rapid Medical Enrolls the First Patient in the DISTALS Stroke Trial–Offering Treatment to New Ischemic Stroke Patient Population

Rapid Medical Enrolls the First Patient in the DISTALS Stroke Trial–Offering Treatment to New Ischemic Stroke Patient Population

The trial is the first-ever FDA investigational device exemption (IDE) trial to examine the safety and effectiveness of mechanical thrombectomy in distal stroke. ...

ByRapid Medical


TecTraum Announces Completion of Multisite Clinical Trial Using pro2cool Device for the Treatment of Concussions

TecTraum Announces Completion of Multisite Clinical Trial Using pro2cool Device for the Treatment of Concussions

Following the successful completion of pilot studies, clinical investigators enrolled 174 patients between the ages of 12 and 21 in the largest single concussion therapy trial known to validate the effectiveness, safety, and tolerability of the system. “As the principal investigator in the study we are thankful for the hard work of the research team from ...

ByTecTraum Inc.


Pollen, Mold and Other Indoor Contaminants Impact Puerto Rico’s Allergy and Asthma Rates

Pollen, Mold and Other Indoor Contaminants Impact Puerto Rico’s Allergy and Asthma Rates

” Zimmetry’s building science professionals provide comprehensive site investigations with indoor environmental quality testing services to improve conditions in all types of buildings throughout Puerto Rico for those suffering from allergic conjunctivitis or from other conditions due to exposure to respiratory allergens, irritants and asthma ...

ByCochrane & Associates, LLC


SafeHeal Announces Successful Launch of IDE Study for Colovac Endoluminal Bypass Sheath

SafeHeal Announces Successful Launch of IDE Study for Colovac Endoluminal Bypass Sheath

Colovac is intended as an alternative to temporary diverting ostomy for patients undergoing colorectal resection. Up to 20 U.S. and European sites will enroll patients in the study. Tampa General Hospital, Tampa, Fla., under the direction of site Principal Investigator Jorge Marcet, MD, professor of the Department of Surgery and director, Colon ...

BySafeHeal


Edinburgh Molecular Imaging and Mauna Kea Technologies Announce Clinical Molecular Imaging Collaboration

Edinburgh Molecular Imaging and Mauna Kea Technologies Announce Clinical Molecular Imaging Collaboration

In a first study, EM Imaging will supply EMI-137, a safe and well-tolerated clinical grade investigational molecular optical imaging agent to two investigational sites to perform clinical efficacy studies in pancreatic and lung cancers. ...

ByEdinburgh Molecular Imaging


PROCEPT Announces 5-Year WATER Study Data Comparing Aquablation to TURP

PROCEPT Announces 5-Year WATER Study Data Comparing Aquablation to TURP

To view the publication, visit: https://www.canjurol.com/html/free-articles/Cdn_JU29_I1_05_FREE_DrGilling.pdf 1Dr. Alexis E. Te was a study site principal investigator for the WATER study and consultant to PROCEPT BioRobotics. ...

ByPROCEPT BioRobotics Corporation


atHeart Medical Receives FDA Approval for the Second Phase of the ASCENT ASD U.S. IDE Trial

atHeart Medical Receives FDA Approval for the Second Phase of the ASCENT ASD U.S. IDE Trial

“As we initiate the second phase, our team is focused on adding clinical sites across the U.S. and expanding internationally to include several enrolling sites in France. ...

ByatHeart Medical


First Patient Dosed in UroGen Pharma’s Home Instillation Study of UGN-102 in Patients with Low-Grade Intermediate Risk Non-Muscle Invasive Bladder Cancer (LG IR-NMIBC)

First Patient Dosed in UroGen Pharma’s Home Instillation Study of UGN-102 in Patients with Low-Grade Intermediate Risk Non-Muscle Invasive Bladder Cancer (LG IR-NMIBC)

The initial treatment visit will occur at the investigative site and instillation will be performed by a qualified physician. ...

ByUroGen Pharma, Inc.


Bluewind Medical Ltd. Completes OASIS Study Patient Enrollment

Bluewind Medical Ltd. Completes OASIS Study Patient Enrollment

“I am proud of our courageous field team that traveled throughout the pandemic, who along with our R&D colleagues in Israel, collaborated to ensure investigative sites and patients had optimal support during the study’s enrollment ...

ByBlueWind Medical


TecTraum’s pro2cool Receives FDA Designation as a Breakthrough Device for the Treatment of Concussions

TecTraum’s pro2cool Receives FDA Designation as a Breakthrough Device for the Treatment of Concussions

Following the successful completion of pilot studies, TecTraum is nearing completion of a large multi-site pivotal clinical trial to validate the effectiveness, safety, and tolerability of the system in patients between the ages of 12 and 21. ...

ByTecTraum Inc.


Thermo Fisher Scientific Showcases Investment and Innovation During CPhI Worldwide 2021

Thermo Fisher Scientific Showcases Investment and Innovation During CPhI Worldwide 2021

Biologics Development and Manufacturing Thermo Fisher has recently assumed operational responsibility for a new 1.5-million-square-foot biologics manufacturing site in Lengnau, Switzerland as part of its strategic partnership with CSL Limited. ...

ByThermo Fisher Scientific


First Five Patients Successfully Treated with atHeart Medical’s Novel reSept Atrial Septal Defect Occluder in U.S. IDE Pivotal Trial

First Five Patients Successfully Treated with atHeart Medical’s Novel reSept Atrial Septal Defect Occluder in U.S. IDE Pivotal Trial

atHeart Medical, a medical device company dedicated to establishing the new standard of care for closure of atrial septal defects (ASD), today announced the successful treatment of the first five patients in its ASCENT ASD U.S. Investigational Device Exemption (IDE) pivotal trial. This study, the company’s first in the US, will evaluate the safety and efficacy of the reSept ...

ByatHeart Medical


Cytovale Begins Enrollment in FDA 510(k) Clinical Validation Study of IntelliSep Rapid Sepsis Test

Cytovale Begins Enrollment in FDA 510(k) Clinical Validation Study of IntelliSep Rapid Sepsis Test

The first patients to participate in CV-SQuISH-ED were enrolled by Dr. Tonya Jagneaux, site principal investigator at Our Lady of the Lake Regional Medical Center in Baton Rouge, La. and by Dr. Daniel Henning, a University of Washington emergency medicine physician and site principal investigator at Harborview Medical Center in ...

ByCytovale Inc.


INOVIO Announces Positive Results from REVEAL 1, a Phase 3 Pivotal Trial Evaluating VGX-3100, its DNA-based HPV Immunotherapy for the Treatment of High-grade Precancerous Cervical Dysplasia Caused by HPV-16 and/or HPV-18

INOVIO Announces Positive Results from REVEAL 1, a Phase 3 Pivotal Trial Evaluating VGX-3100, its DNA-based HPV Immunotherapy for the Treatment of High-grade Precancerous Cervical Dysplasia Caused by HPV-16 and/or HPV-18

Mark Einstein, MD, MS, FACS, FACOG, Principal Coordinating Investigator for the REVEAL 1 trial, said, "There is a very significant need for a non-surgical therapeutic for young women suffering from HPV-associated cervical dysplasia. ...

ByINOVIO Pharmaceuticals


Thermo Fisher Scientific Expands Clinical Supply Chain Services in Europe

Thermo Fisher Scientific Expands Clinical Supply Chain Services in Europe

Approximately 4,000 clinical trials are conducted each year in Europe, which is 20% of the global clinical trials market.* These facilities feature innovative and highly automated technologies to optimize efficiency and quality across the pharma services supply chain. The Rheinfelden site opens in late December 2020 and the Weil am Rhein site will open in ...

ByThermo Fisher Scientific, LIMS & Laboratory Software


Alume Receives SBIR Phase II Grant from the NIH to Support Clinical Trial of ALM-488 to Highlight Nerves in Patients Undergoing Head & Neck Surgery

Alume Receives SBIR Phase II Grant from the NIH to Support Clinical Trial of ALM-488 to Highlight Nerves in Patients Undergoing Head & Neck Surgery

This grant will support Alume's clinical development of its novel nerve illumination technology in surgery. The Principal Investigators on this grant are Michael Whitney, PhD, Scientific Co-Founder and Vice President of Discovery and Brett Berman, MD, Co-Founder and Chief Medical Officer at Alume. ...

ByAlume Biosciences, Inc.

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