Institutional review board

WCG Revolutionizes Ethical Review Process with IRB+ Service, Achieving Unprecedented Efficiency Gains

Retrieved on: 
Thursday, November 30, 2023
IRB, Institutional review board, Clinical trial, Research, Safety, IBC, ChromeOS, WCG, Pharmaceutical industry

Mark McDonald, president, WCG Review Solutions, expressed his enthusiasm for the launch, "IRB+ represents a significant leap forward in our commitment to advancing the efficiency and quality of clinical trial processes.

Key Points: 
  • Mark McDonald, president, WCG Review Solutions, expressed his enthusiasm for the launch, "IRB+ represents a significant leap forward in our commitment to advancing the efficiency and quality of clinical trial processes.
  • We've taken a bold step in addressing the critical need for accelerated review processing without compromising the high standards of ethical oversight.
  • "IRB+ provides a tailored solution for those looking to optimize their study timelines without compromising the quality or integrity of the ethical review.
  • WCG's IRB+ marks a new era in clinical trial efficiency, combining cutting-edge technology, dedicated expertise, and a commitment to ethical oversight and participant safety.

Redwood Scientific Technologies Receives Conditional Approval from IRB/CIRB for Groundbreaking Clinical Studies

Retrieved on: 
Tuesday, November 14, 2023
Institutional review board, TBX, IRB, CIRB, Trial of the century, Nicotine, Tobacco, Sequoioideae

NEW YORK, Nov. 14, 2023 /PRNewswire/ -- Redwood Scientific Technologies ( RSCI OTC PINK ) is pleased to announce that, as of 11-13-2023 at 10:42 AM, it has secured conditional approval from the Institutional Review Board (IRB)/Central Institutional Review Board (CIRB).

Key Points: 
  • NEW YORK, Nov. 14, 2023 /PRNewswire/ -- Redwood Scientific Technologies ( RSCI OTC PINK ) is pleased to announce that, as of 11-13-2023 at 10:42 AM, it has secured conditional approval from the Institutional Review Board (IRB)/Central Institutional Review Board (CIRB).
  • This milestone marks a significant advancement in Redwood's ongoing efforts towards clinical study work, aiming to develop and introduce an Oral Thin Film Strip to address nicotine addiction in vape devices.
  • Redwood envisions being the pioneer in the market with a nicotine-free solution for addiction to nicotine in e-cigarettes or vape devices.
  • This conditional approval from IRB/CIRB signifies a crucial step forward for Redwood Scientific Technologies in its commitment to addressing nicotine addiction across various mediums.

Omega Therapeutics Reports Third Quarter 2023 Financial Results and Highlights Recent Company Progress

Retrieved on: 
Thursday, November 9, 2023
EGFR, Research, HCC, NSCLC, AACR, Rheumatism, American Association for the Study of Liver Diseases, OMEGA, IND, International, Therapy, Hepatology, Flagship Pioneering, Liver regeneration, G&A, Investigational New Drug, Conference, Palatine Nos. 1–8, 21, Fibrosis, Dive (Belgian band), MYC, Hepatitis, R, Pharmacokinetics, Acute respiratory distress syndrome, Omega, Epigenomics, Lung, Tissue, Annual report, Messenger, LNP, Institutional review board, Inflammation, Lung cancer, Hepatocellular carcinoma, Cancer, Patient, Gene expression, AASLD, Management, Pharmaceutical industry, Vaccine, Dietary supplement

As of September 30, 2023, the Company had cash, cash equivalents and marketable securities totaling $89.3 million.

Key Points: 
  • As of September 30, 2023, the Company had cash, cash equivalents and marketable securities totaling $89.3 million.
  • Research and development (R&D) expenses for the third quarter of 2023 were $16.5 million, compared to $20.7 million for the third quarter of 2022.
  • General and administrative (G&A) expenses for the third quarter of 2023 were $7.9 million, compared to $5.2 million for the third quarter of 2022.
  • Net loss for the third quarter of 2023 was $22.2 million, compared to $25.8 million for the third quarter of 2022, driven predominantly by a decrease in R&D expenses.

RetinalGeniX IRB Approved to Conduct Study to Personalize Medical Evaluations for Patients Receiving Treatment for Wet Macular Degeneration

Retrieved on: 
Monday, October 30, 2023
Biomarker, Ophthalmology, Institutional review board, Intravitreal injection, Hematology, AMD, BrightFocus Foundation, MD, Research, Anti-VEGF, OTCQB, JAMA Ophthalmology, News, Disease, University, Personalized medicine, Blood, Safety, Patient, Pharmaceutical industry

The study aims to offer recommendations for enhancing the preselection process and management of ocular injections.

Key Points: 
  • The study aims to offer recommendations for enhancing the preselection process and management of ocular injections.
  • The proposed patient selection process has the potential to reduce the cost and improve the safety and efficacy of patient candidate selection for ocular injections.
  • “RetinalGeniX DNA/GPS has submitted a study with Pearl IRB to perform a clinical review of 390 patients.
  • Jerry Katzman, MD, the CEO of RetinalGeniX, emphasized the importance of limiting ocular anti-VEGF injections into patients’ eyes for those who are good candidates for responsive treatment.

Movano Health's Proprietary Chip and Prototype Achieves Accuracy Commensurate with the FDA's Requirements for Blood Pressure Monitoring

Retrieved on: 
Tuesday, October 31, 2023
FDA, Trial of the century, IRB, Blood pressure, American Heart Association, Prehypertension, Radio, MAD, Calibration, Hypertension, Clinical trial, Institutional review board, Algorithm, Noise, AI, Evie, Medical imaging, Medical device, SOC

PLEASANTON, Calif., Oct. 31, 2023 /PRNewswire/ -- Movano Health (Nasdaq: MOVE), a purpose-driven healthcare solutions company at the intersection of medical and consumer devices and makers of the Evie Ring, today announced the results of its Institutional Review Board (IRB)-approved blood pressure clinical study. Movano Health's prototype, which incorporated its SoC, demonstrated a level of accuracy within the standards recognized by the FDA for blood pressure monitoring devices. The Company's algorithm for blood pressure monitoring utilized data from its prototype system combined with the subject's demographic information and a recent blood pressure reading.

Key Points: 
  • Movano Health's prototype, which incorporated its SoC, demonstrated a level of accuracy within the standards recognized by the FDA for blood pressure monitoring devices.
  • The Company's algorithm for blood pressure monitoring utilized data from its prototype system combined with the subject's demographic information and a recent blood pressure reading.
  • The 44-participant study, conducted at the Movano Health Clinical Lab, assessed the accuracy of its wrist-worn wearable prototype compared to a hospital-grade FDA-cleared blood pressure monitor.
  • In its current form factor, Movano Health's wearable prototype represents one of the smallest and most accessible ways to measure blood pressure.

Positive results from first-in-human completely leadless CRT in the US, published in The Journal of the American College of Cardiology

Retrieved on: 
Wednesday, October 25, 2023
NYHA, American College, Food, CRT, LVEF, Cardiac resynchronization therapy, Heel, McCutcheon, ASX, Achilles, Institutional review board, Coronary sinus, Wise, Journal, Cardiology, Patient, Food and Drug Administration, Heart failure, MD, Nissan Micra, JACC, Research, Growth, QRS, FDA, IRB, Cardiac electrophysiology, Journal of the American College of Cardiology, EBR, Medtronic, Failure, Medical device, Television, Pharmaceutical industry

The positive results published in JACC are based on a 1-year follow-up of the first-in-human implantation in the US of totally leadless CRT pacing utilizing the Micra™ leadless pacing system in the right ventricle in conjunction with EBR's investigational WiSE® CRT Electrode in the left ventricle of the heart.

Key Points: 
  • The positive results published in JACC are based on a 1-year follow-up of the first-in-human implantation in the US of totally leadless CRT pacing utilizing the Micra™ leadless pacing system in the right ventricle in conjunction with EBR's investigational WiSE® CRT Electrode in the left ventricle of the heart.
  • This first use in the US of the WiSE CRT System as a first-line therapy is a future market expansion opportunity for EBR.
  • "It's great to see these positive results being published in a world-leading cardiology journal, such as The Journal of the American College of Cardiology," said John McCutcheon, President & CEO of EBR Systems.
  • "This case study highlights the potential of totally leadless CRT for patients struggling with traditional CRT, but also beyond these patient groups, the 64 million heart failure patients across the globe."

Feinstein Institutes Awarded $6.1M to Fund Bipolar Disorder Patient and Research Hub

Retrieved on: 
Thursday, October 19, 2023
Mental Health, Health, Biometrics, Clinical Trials, Research, Science, Biotechnology, Knowledge, Patient, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Medical research, Feinstein, Feinstein Institutes for Medical Research, Transcranial magnetic stimulation, Johns Hopkins University, Zucker Hillside Hospital, Hofstra University, Psychiatry, Bipolar disorder, Multimedia, Donald, Clinical trial, Schizophrenia, Institutional review board, Behavioural sciences, Credit, University, Magnetic resonance imaging, University of California, Los Angeles, BD2, University of Michigan, Hospital, BSN, Mayo Clinic, Pharmaceutical industry, MD, Brigham, Wellcome

Approximately 2.3 million Americans live with bipolar disorder who are impacted by dramatic shifts in mood, energy and activity levels.

Key Points: 
  • Approximately 2.3 million Americans live with bipolar disorder who are impacted by dramatic shifts in mood, energy and activity levels.
  • Through a national research grant and innovative networking system aimed to connect patients to care, it might become easier for people with bipolar disorder to find new treatments and clinical trials.
  • (Credit: Feinstein Institutes)
    Researchers at The Feinstein Institutes for Medical Research received a $6.1 million grant from Breakthrough Discoveries for Thriving with Bipolar Disorders Foundation (BD2) to serve as a hub of six other sites across the country.
  • “Although bipolar disorder impacts millions of Americans every year, it is under-researched,” said Kevin J. Tracey, MD , president and CEO of the Feinstein Institutes and Karches Family Distinguished Chair in Medical Research.

BIOXCEL ALERT: Bragar Eagel & Squire, P.C. is Investigating BioXcel Therapeutics, Inc. on Behalf of Long-Term Stockholders and Encourages Investors to Contact the Firm

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Thursday, October 12, 2023
Class Action Lawsuit, Professional Services, Legal, Jeanne Eagels (film), Nursing, Food, Telephone, Defendant, Food and Drug Administration Amendments Act of 2007, Dementia, Institutional review board, Safety, P.C, Record, FDA, Therapy, Agitation, News, Patient, Cryptocurrency, Pharmaceutical industry

Our investigation concerns whether the board of directors of BioXcel have breached their fiduciary duties to the company.

Key Points: 
  • Our investigation concerns whether the board of directors of BioXcel have breached their fiduciary duties to the company.
  • On December 15, 2021, the Company announced that it had initiated a program to evaluate BXCL501 for the treatment of acute agitation associated with Alzheimer’s disease.
  • The Company announced that the program consisted of two randomized, double-blind, placebo-controlled studies: TRANQUILITY II and TRANQUILITY III.
  • BioXcel further disclosed that the fabricated email correspondence was provided to the FDA during an on-site inspection in December 2022.

 GE HealthCare’s growing list of medical institutions conducting human subject research studies with its novel photon counting CTi technology further expands with the addition of Stanford Medicine

Retrieved on: 
Monday, October 9, 2023
Technology, Semiconductor, Hospitals, Other Health, Biotechnology, Radiology, University, Pharmaceutical, Health, Education, Photon, Silicon, MBA, Doctor of Philosophy, Research, MD, Institutional review board, Cardiology, Neurology, Absorption, Stanford University School of Medicine, Electrical engineering, Molecular imaging, General Electric, CE, Stanford Research Park, Assistant professor, GE, CT scan, Sale, GE HealthCare, Patient, University of Texas Health Science Center Department of Radiology, Medical imaging, Pharmaceutical industry

Altogether, it has the promise to be a substantial step forward for CT imaging that can potentially benefit millions of patients worldwide.

Key Points: 
  • Altogether, it has the promise to be a substantial step forward for CT imaging that can potentially benefit millions of patients worldwide.
  • Photon counting technology marks what is probably the most significant technological advancement in CT in more than a decade, and perhaps longer.”
    Stanford Medicine researchers will facilitate human subject research and produce technical feedback to test and help advance GE HealthCare’s photon counting CT technology with Deep Silicon.
  • From the first x-ray machines to the first silicon-based photon counting prototype, GE HealthCare is committed to pioneering next generation imaging technology.
  • GEiv researchers began studying photon counting CT in 1993 and developed the world’s first photon counting CT prototype using cadmium-based detectors in 2006.

DR. CHRISTINA RAHM AUTHORS 'BE YOUR OWN INSPIRATION' AS PART OF HER CURE THE CAUSES BOOK SERIES

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Wednesday, October 11, 2023
Parent, Health, Knowledge, United Nations, Lyme disease, Mayo Clinic, Cookbook, Life, Master of Science in Development Administration, Literacy, Inflammation, Wake Forest, Cooking, Institutional review board, Harvard University, Cornell University, Disease, Cancer, Cosmetics, Mental health, IRB, Johns Hopkins, University, Woman, Cleveland Clinic, Entertainment, Nursing, Pharmaceutical industry, Philosophy, Education, Nanotechnology, Nutrition, Science

NASHVILLE, Tenn., Oct. 11, 2023 /PRNewswire/ -- Her third book to date, Dr. Christina Rahm, has written 'Be Your Own Inspiration,' as part of her Cure the Causes book series. A multi-talented, scientist, patent innovator, scientific formulator, humanitarian, mother of four, and author was recently featured in FORBES Magazine for her initial print work, Cure the Causes, after suffering debilitating illnesses of both Lyme disease and cancer. Her second publication, 'Cure The Causes Cookbook' was also written with clinical teachings in mind; the successful Cookbook educates on the disciplines of cooking with ingredients to help combat inflammation and disease, plus a myriad of recipes to support chronic health ailments.

Key Points: 
  • NASHVILLE, Tenn., Oct. 11, 2023 /PRNewswire/ -- Her third book to date, Dr. Christina Rahm, has written 'Be Your Own Inspiration,' as part of her Cure the Causes book series.
  • Her vision for 'Be Your Own Inspiration,' was to provide tools to identify an individual's passion, to live a life which aligns with their values.
  • In this book, Rahm draws from her own experiences, combined with her extensive knowledge on health topics, to provide readers with tools to take charge of their own well-being.
  • Under the DRC Ventures umbrella, Rahm Roast, Ella Pure Skin Care, and Merci Dupre Clothiers were recently rolled out.