National Institute of Biomedical Imaging and Bioengineering

3EO Health Receives NIH RADx® Tech Award to Expand Application of its 3TR Point of Care Technology

Retrieved on: 
Monday, October 16, 2023
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With the NIH RADx Tech award, 3EO Health will accelerate and expand the development and application of its novel 3TR technology into a multiplex format.

Key Points: 
  • With the NIH RADx Tech award, 3EO Health will accelerate and expand the development and application of its novel 3TR technology into a multiplex format.
  • "We are honored to be chosen as recipients of the RADx Tech award from NIBIB," said Jeremy Schubert, CEO of 3EO Health.
  • "3EO Health's innovative approach holds immense promise for the future of diagnostic testing," said Peter Honkanen M.S.M., B.S.E.E., Chief Technology officer of 3EO Health.
  • 3EO Health Inc. is a “Point of Life” diagnostic company leveraging novel technology to exponentially lower cost and expand clinical and community access to high impact diagnostic tools.

Perosphere Technologies Awarded Federal Grants for Point-of-Care Coagulometer

Retrieved on: 
Tuesday, September 19, 2023
General Health, Health, Medical Devices, POC, Pharmacy, SBIR, National Heart, Lung, and Blood Institute, Research, Medical imaging, Lung, ACME, Bangladesh Technical Education Board, NHLBI, Hospital, Physician, Coagulation, National Institute of Biomedical Imaging and Bioengineering, Biological engineering, NIH, Pharmaceutical industry, Medical device

Perosphere Technologies (Perosphere Technologies Inc.), a private medical technologies company focused on developing coagulation diagnostics, has today announced the receipt of two prestigious federal grants: a Direct Phase II Small Business Innovation Research (SBIR) grant from the National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health (NIH), and a subaward through an Atlanta Center for Microsystems Engineered Point-of-Care Technologies (ACME POCT) Center Grant, funded by the National Institute of Biomedical Imaging and Bioengineering (NIBIB/NIH).

Key Points: 
  • Perosphere Technologies (Perosphere Technologies Inc.), a private medical technologies company focused on developing coagulation diagnostics, has today announced the receipt of two prestigious federal grants: a Direct Phase II Small Business Innovation Research (SBIR) grant from the National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health (NIH), and a subaward through an Atlanta Center for Microsystems Engineered Point-of-Care Technologies (ACME POCT) Center Grant, funded by the National Institute of Biomedical Imaging and Bioengineering (NIBIB/NIH).
  • The grants, totaling over $2MM, will fund the further development and commercialization of a novel point-of-care (PoC) coagulometer, known as the Perosphere Technologies POC Coagulometer.
  • “We are very honored to receive these grants from NIH and ACME POCT, as they will present a unique opportunity to further expand our groundbreaking point-of-care coagulation diagnostics technology,” said Dr. Stefan Zappe, Principal Investigator and Chief Technology Officer at Perosphere Technologies.
  • “Perosphere Technologies aims to revolutionize coagulation testing by providing healthcare professionals with accurate and timely results.”
    “The potential applications of the Perosphere Technologies PoC Coagulometer will greatly expand thanks to these grant awards, accelerating our understanding of disease mechanisms and therapeutic approaches,” said Dr. Sasha Bakhru, CEO of Perosphere Technologies.

Diagmetrics Receives NIH RADx® Award to Advance its Mask Based Diagnostic Platform

Retrieved on: 
Wednesday, August 9, 2023
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MADISON, Conn., Aug. 9, 2023 /PRNewswire-PRWeb/ -- DiagMetrics Inc. announced today that it has been awarded Phase 1 funding from the National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADx®) Tech program in support of its Mask-Based Diagnostic (MBD™) for rapid detection of COVID-19 for use by individuals with disabilities. The initial award of $938,784.25 has the potential for Phase 2 funding pending successful completion of Phase 1. The RADx Tech award is funded by National Institute of Biomedical Imaging and Bioengineering (NIBIB) and will help DiagMetrics continue the development and validation of its novel Mask Based Diagnostic platform as it progresses to product commercialization.

Key Points: 
  • The initial award of $938,784.25 has the potential for Phase 2 funding pending successful completion of Phase 1.
  • The RADx Tech award is funded by National Institute of Biomedical Imaging and Bioengineering (NIBIB) and will help DiagMetrics continue the development and validation of its novel Mask Based Diagnostic platform as it progresses to product commercialization.
  • The DiagMetrics' MBD provides a simple way for users with disabilities to perform a COVID-19 test by themselves.
  • "The user simply puts on a mask, presses a button to activate the test, and breathes normally for a few minutes.

Domus Diagnostics Moves Closer to Delivering Affordable At-Home Molecular Test for COVID-19, Flu-A, Flu-B and RSV

Retrieved on: 
Wednesday, May 24, 2023
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The award, up to $2.4M through the NIH’s Rapid Acceleration of Diagnostics (RADx®) Tech program, will support accelerated validation and scaling of Domus Diagnostics' testing platform for clinical trial readiness.

Key Points: 
  • The award, up to $2.4M through the NIH’s Rapid Acceleration of Diagnostics (RADx®) Tech program, will support accelerated validation and scaling of Domus Diagnostics' testing platform for clinical trial readiness.
  • The Domus Diagnostics' platform is an ultra-low cost, zero-power testing platform that will produce novel devices that enable user-friendly, accurate, and effective infectious disease testing at home, in doctors’ offices, or in community testing facilities.
  • The devices will provide a significantly more affordable and accessible global option for infectious disease testing.
  • The Domus technology doesn’t require any instrumentation, electricity, or even batteries to run – making it a zero-power testing solution.

C2Sense and Princeton BioMeditech receive NIH RADx ® Tech Funding to Advance a Digitally Connected At-Home Diagnostic Reader for Sensitivity Enhancement of an OTC COVID-19/Flu A&B Rapid Test

Retrieved on: 
Tuesday, May 16, 2023
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WATERTOWN, Mass. and MONMOUTH JUNCTION, N.J., May 16, 2023 /PRNewswire/ -- C2Sense, Inc., experts in advanced optical sensing platforms and Princeton BioMeditech Corporation (PBM), a world leader in rapid, point-of-care (POC) diagnostics, announced today that they have been awarded Phase 1 funding from the National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADx) Tech High Performance program. This funding will be used to advance Halo, a low-cost, high sensitivity digitally connected diagnostic reader, and convert PBM's colorimetric OTC COVID-19/Flu A&B multiplexed lateral flow assay (LFA) to a fluorescent immunoassay (FIA).

Key Points: 
  • This funding will be used to advance Halo, a low-cost, high sensitivity digitally connected diagnostic reader, and convert PBM's colorimetric OTC COVID-19/Flu A&B multiplexed lateral flow assay (LFA) to a fluorescent immunoassay (FIA).
  • The purpose of this NIH RADx initiative, launched in April 2020, is to speed the development, commercialization and implementation of rapid and reliable technologies for COVID-19 detection.
  • The third funding announcement from the RADx Tech program focuses on the near-term commercial deployment of easy-to-use tests that reduce reliance on serial testing and are future-proof towards new variants.
  • "We are excited to build upon our successful NIH RADx experience with this new opportunity."

National Institutes of Health Awards Clarkson University ESTEEMED Grant to Advance the Diversity of the Bioengineering Workforce

Retrieved on: 
Tuesday, May 9, 2023
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Potsdam, NY, May 09, 2023 (GLOBE NEWSWIRE) -- A new pathway for students to learn about bioengineering research is coming to Clarkson University.

Key Points: 
  • Potsdam, NY, May 09, 2023 (GLOBE NEWSWIRE) -- A new pathway for students to learn about bioengineering research is coming to Clarkson University.
  • Clarkson has been awarded $660,475 by the National Institute of Biomedical Imaging and Bioengineering of the National Institutes of Health as part of its Enhancing Science, Technology, Engineering, and Math Educational Diversity (ESTEEMED) Research Education Experiences program.
  • With this grant, the university will launch the Bioengineering Research Education to Accelerate Innovation in STEM (BOREALIS) Scholars program aimed at preparing a diverse cadre of students for careers in biomedical research.
  • The BOREALIS Scholars Program will educate, encourage, and support the students to enter the bioengineering workforce by creating a pathway to bioengineering graduate study.

United States Monkeypox Testing Market Outlook & Forecasts 2023-2025: Strong Future Diagnostic Pipeline - Market is Projected to Grow at a Staggering CAGR of 74.26% - ResearchAndMarkets.com

Retrieved on: 
Friday, April 14, 2023
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The U.S. monkeypox testing market was valued at USD 5,336.29 thousand in 2022 and is expected to reach USD 91.00 thousand by 2025.

Key Points: 
  • The U.S. monkeypox testing market was valued at USD 5,336.29 thousand in 2022 and is expected to reach USD 91.00 thousand by 2025.
  • From day one of this outbreak, providers had access to a high-quality, FDA-cleared test to detect monkeypox.
  • The regulatory bodies approved the products faster and increased access to monkeypox testing, which further accelerated the U.S. monkeypox testing market.
  • However, this reduced the number of tests conducted in the market, which became a limitation for the U.S. monkeypox testing market.

GenBody America Receives Amendment to FDA Emergency Use Authorization for Updated Point-of-Care Test Kits with Individual Reagents

Retrieved on: 
Thursday, September 1, 2022
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Were very pleased that the FDA has amended our authorizations, said David Yoo, CEO of Genbody America.

Key Points: 
  • Were very pleased that the FDA has amended our authorizations, said David Yoo, CEO of Genbody America.
  • Were proud to offer a new level of accessibility with our point-of-care kits that equips our customers with individual reagents.
  • GenBody America is the U.S. manufacturer for GenBody, Inc. , a leading South Korean manufacturer of rapid diagnostic tests and reagents for point-of-care applications for COVID-19 and other diseases.
  • The GenBody COVID-19 Ag Test has been authorized by the FDA under an EUA for use by authorized laboratories, pending full FDA clearance.

Preparing for Continuing Battle with COVID, MicroGEM Partners with Medline to Equip Healthcare Providers with World's First Saliva PCR Test for Point of Care

Retrieved on: 
Wednesday, August 17, 2022
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CHARLOTTESVILLE, Va., Aug. 17, 2022 /PRNewswire/ -- MicroGEM, a U.S.-based molecular biology company, today announced that Medline, a manufacturer and distributor of medical supplies to healthcare providers across the continuum of care, is now offering the MicroGEM Sal6830 Point of Care PCR System and SARS-CoV-2 Saliva Test.

Key Points: 
  • "Our partnership with MicroGEM expands our product portfolio to offer a saliva-based test for the first time.
  • Medline is a healthcare company; a manufacturer, distributor, and solutions provider focused on improving the overall operating performance of healthcare.
  • Partnering with healthcare systems and facilities across the continuum of care, Medline provides the clinical and supply chain resources required for long-term financial viability in delivering high-quality care.
  • Headquartered in Northfield, Ill., Medline has 30,000+ employees worldwide and does business in more than 125 countries and territories.

FDA Grants Extension of Shelf-life & Expiration Date for GenBody COVID-19 Ag Test

Retrieved on: 
Thursday, August 4, 2022
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This extension was granted after FDA review of long-term studies demonstrating that the GenBody tests maintain their performance long after the initially defined 12-month window.

Key Points: 
  • This extension was granted after FDA review of long-term studies demonstrating that the GenBody tests maintain their performance long after the initially defined 12-month window.
  • Ensuring the consistent performance of the GenBody test device over time is critical, said Dr. Andrew Kim, Chief Medical Officer of GenBody America.
  • GenBodys COVID-19 antigen test is one of a handful of visually readable tests that is EUA authorized by the FDA.
  • The GenBody COVID-19 Ag test has been authorized by the FDA under an EUA for use by authorized laboratories, pending full FDA clearance.