Biosafety

NSG BioLabs Fuels Biotech Innovation in Singapore and Southeast Asia Through Partnerships with EnterpriseSG and Merck, Alongside Investments from Celadon Partners and ClavystBio

Retrieved on: 
Wednesday, May 8, 2024
Ecosystem, Incubator, Daphne, Health, Health care, Biosafety, Partnership, Research, Biomedicine, Science, Synthetic biology, Temasek, NSG, Spirit level, Enterprise Singapore, Medicine, Dicarboxylic acid, Growth

Moreover, these milestones underscore NSG BioLabs as an ecosystem catalyst, providing value-add services and networks, which are important in driving scientific innovation and business growth.

Key Points: 
  • Moreover, these milestones underscore NSG BioLabs as an ecosystem catalyst, providing value-add services and networks, which are important in driving scientific innovation and business growth.
  • With the largest co-working biotech laboratory and office footprint in Singapore, coupled with extensive networks with partners, suppliers and industry experts, NSG BioLabs has helped over 40 companies as residents.
  • To further its mission of supporting biotech innovators, NSG BioLabs also closed a US$14.5 million strategic investment round, led by Celadon Partners with participation from ClavystBio.
  • Now, with three sites totaling 35,000 square feet, NSG BioLabs cements its space as a key hub for biotech innovation.

PRENOSIS ANNOUNCES COMMERCIAL DISTRIBUTION COLLABORATION WITH ROCHE FOR SEPSIS IMMUNOSCORE™, THE FIRST FDA DE NOVO AUTHORIZED ARTIFICIAL INTELLIGENCE TOOL FOR SEPSIS DETECTION

Retrieved on: 
Wednesday, April 10, 2024
FDA, Recognition, Procalcitonin, Risk, Hospital, Electronic health record, AI, De novo, Suite, Biosafety, Quality, EMR, Partnership, Collection, Artificial intelligence, Economic impact analysis, Therapy, Data, Patient, Treatment, FACEP, Mortality, Multimedia, Diagnosis, Biology, Biomarker, Medicine, Implementation, Algorithm, Infection, Medical device

CHICAGO, April 10, 2024 /PRNewswire/ -- Today, Prenosis, Inc., an artificial intelligence company enabling precision medicine in acute care, announced a commercial distribution collaboration with Roche for its Sepsis ImmunoScore™, an artificial intelligence/machine learning software as a medical device (AI SaMD) to guide rapid diagnosis of sepsis and prediction of adverse outcomes. The Sepsis ImmunoScore™, the first-ever FDA De Novo authorized AI diagnostic tool for sepsis, will be available on Roche's navify® Algorithm Suite. The Suite provides the advantage of offering Roche and third party evidence-based, certified medical algorithms to customers in one solution platform (spanning disease areas). Offering clinicians and lab managers an integrated solution, navify® Algorithm Suite aims to transform every stage of care and for confident decision making.

Key Points: 
  • The Sepsis ImmunoScore™, the first-ever FDA De Novo authorized AI diagnostic tool for sepsis, will be available on Roche's navify® Algorithm Suite.
  • "Strategies and solutions have fallen short of expectations, placing patients at risk by overcalling sepsis in patients without sepsis, while overlooking many patients with sepsis.
  • The Sepsis ImmunoScore™ – the first-ever AI sepsis diagnostic granted De Novo authorization by the FDA – provides a validated diagnostic and predictive solution, ushering in a true Clinician-AI partnership.
  • "Including the Sepsis ImmunoScore in Roche's navify® Algorithm Suite is a great step forward for the Sepsis ImmunoScore™," said Bobby Reddy, Jr., Prenosis Co-Founder and CEO.

PRENOSIS ANNOUNCES FDA DE NOVO MARKETING AUTHORIZATION OF THE SEPSIS IMMUNOSCORE™, ITS REVOLUTIONARY ARTIFICIAL INTELLIGENCE DIAGNOSTIC AND PREDICTIVE TOOL FOR EARLY SEPSIS DETECTION

Retrieved on: 
Wednesday, April 3, 2024
Diagnosis, De novo, Sepsis, Algorithm, Disease, Infection, Partnership, Trust, Risk, Patient, Intuition, Biomarker, Hospital, Cancer, AI, Biosafety, Quality of life, Emergency department, Medicine, Biology, Risk assessment, Length of stay, Therapy, Medicare, Data, ICU, FDA, Health, Electronic health record, Food, Medical device

CHICAGO, April 3, 2024 /PRNewswire/ -- Prenosis, Inc., an artificial intelligence company enabling precision medicine in acute care, today announced the U.S. Food and Drug Administration (FDA) has granted marketing authorization for the Sepsis ImmunoScore™ using the De Novo pathway. The Sepsis ImmunoScore™ is an artificial intelligence/machine learning software as a medical device (AI SaMD) to guide rapid diagnosis and prediction of sepsis. This signifies the first-ever FDA marketing authorization of an AI diagnostic tool for sepsis, an extremely complex condition that is difficult to diagnose early and has been a decades-long challenge for the U.S. healthcare system.

Key Points: 
  • The Sepsis ImmunoScore™ is the first-ever AI Sepsis Diagnostic granted marketing authorization by the FDA.
  • The Sepsis ImmunoScore™ is an artificial intelligence/machine learning software as a medical device (AI SaMD) to guide rapid diagnosis and prediction of sepsis.
  • Despite the devastating impact, no AI diagnostic for sepsis had previously received marketing authorization from the FDA until now.
  • "Until now, there was no other FDA authorized AI diagnostic for sepsis, which is why the Sepsis ImmunoScore™ had to be granted marketing authorization through the De Novo pathway.

Sonoran University President Dr. Paul Mittman Announces Retirement

Retrieved on: 
Wednesday, March 27, 2024
Culture, Health, Arizona State University, Private, Advisory board, Community health, Trustee, Education, Biosafety, Research, University, Democracy, Medical Center, Rights, Student, Outline of health sciences, Nursing

TEMPE, Ariz., March 27, 2024 /PRNewswire-PRWeb/ -- Sonoran University of Health Sciences announced today that Dr. Paul Mittman will be retiring in June 2025 after 25 years as president and CEO of the institution.

Key Points: 
  • TEMPE, Ariz., March 27, 2024 /PRNewswire-PRWeb/ -- Sonoran University of Health Sciences announced today that Dr. Paul Mittman will be retiring in June 2025 after 25 years as president and CEO of the institution.
  • While I'm proud of Sonoran University today, I know its best days lie ahead to be written in the next chapters of this amazing institution."
  • Dr. Mittman has served as Sonoran University of Health Sciences' president since 1999 and achieved a variety of great successes for the institution, including:
    Transforming Sonoran University from a single-purpose college to a university with multiple programs and international reach.
  • For more information on Sonoran University, please visit www.sonoran.edu .

Sonoran University President Dr. Paul Mittman Announces Retirement

Retrieved on: 
Wednesday, March 27, 2024
Culture, Health, Arizona State University, Private, Advisory board, Community health, Trustee, Education, Biosafety, Research, University, Democracy, Medical Center, Rights, Student, Outline of health sciences, Nursing

TEMPE, Ariz., March 27, 2024 /PRNewswire/ -- Sonoran University of Health Sciences announced today that Dr. Paul Mittman will be retiring in June 2025 after 25 years as president and CEO of the institution.

Key Points: 
  • TEMPE, Ariz., March 27, 2024 /PRNewswire/ -- Sonoran University of Health Sciences announced today that Dr. Paul Mittman will be retiring in June 2025 after 25 years as president and CEO of the institution.
  • While I'm proud of Sonoran University today, I know its best days lie ahead to be written in the next chapters of this amazing institution."
  • Dr. Mittman has served as Sonoran University of Health Sciences' president since 1999 and achieved a variety of great successes for the institution, including:
    Transforming Sonoran University from a single-purpose college to a university with multiple programs and international reach.
  • For more information on Sonoran University, please visit www.sonoran.edu .

Prenosis Inc. Appoints Leadership Team for Commercialization In Hospitals

Retrieved on: 
Wednesday, October 4, 2023
Infection, Partnership, Society, Research and development, Biomedical Advanced Research and Development Authority, Senior, Sepsis, MSN, Society of Critical Care Medicine, EMR, TED (conference), Robin, Research, Electronic health record, Biomarker, American Thoracic Society, Washington University in St. Louis, Doctor of Philosophy, CIC, Sale, Clinical data standards, Development, Hospital, Verily, MD, Data, Patient, Medicine, Biosafety, RN, Growth, American Association for Clinical Chemistry, Alphabet Inc., BARDA, Medtech, NIH, MDDI, Critical Care Medicine (journal), Management, Nursing, Pharmaceutical industry

CHICAGO, Oct. 4, 2023 /PRNewswire/ -- Prenosis, Inc., an artificial intelligence company enabling precision medicine for abnormal immune responses in acute care, announced today the appointment of Robin Carver, RN, MSN, CIC as Vice President, Health System Engagement, Brian Bray as Vice President, Technology, and an expanded role for Carlos Lopez-Espina as Senior Vice President of Research & Development. Prenosis also announced the addition of Pratik Sinha, MD, PhD, to the company's scientific advisory board.

Key Points: 
  • Prenosis also announced the addition of Pratik Sinha, MD, PhD, to the company's scientific advisory board.
  • Carver and Mr. Bray, executives with over 40 years of combined experience in advancing technology in hospitals, will serve on the executive management team and lead the company's expansion in healthcare systems.
  • "Robin, Brian and Carlos' leadership in commercialization, integration and data will add significant value to the company as we enter the next phase of Prenosis' growth," said Reddy.
  • Prenosis developed its core resource--the world's largest biobank and dataset for decoding abnormal immune responses in acute care--in partnership with over eleven U.S. hospitals.

T2 Biosystems Receives FDA 510(k) Clearance for the T2Biothreat Panel

Retrieved on: 
Tuesday, September 19, 2023
Ochsner Medical Center, ASPR, Burkholderia pseudomallei, Plague, Emergency, Biomedical Advanced Research and Development Authority, CBRN, Office of Inspector General, U.S. Department of Health and Human Services, HHS, Administration for Strategic Preparedness and Response, Public, Infection, Tularemia, Public Health Service Act, Unitary state, Typhus, Biosafety, Glanders, Yersinia pestis, Government, Melioidosis, Bacillus anthracis, Burkholderia mallei, Development, Administration, Disaster, MRIGlobal, Francisella tularensis, Biological warfare, Public health, Patient, Rickettsia prowazekii, Bacillus, Mortality, FDA, Anthrax, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, BARDA, Food, Pharmaceutical industry, Vaccine, Medical device

LEXINGTON, Mass., Sept. 19, 2023 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the T2Biothreat™ Panel.

Key Points: 
  • LEXINGTON, Mass., Sept. 19, 2023 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the T2Biothreat™ Panel.
  • The FDA 510(k) clearance allows the company to immediately begin marketing and selling the T2Biothreat Panel in the U.S. market.
  • The U.S. clinical evaluation to support the FDA 510(k) submission included testing of the T2Biothreat Panel at MRIGlobal, a Biosafety Level 3 laboratory specializing in biothreat pathogens, and Ochsner Medical Center.
  • The T2Biothreat Panel is able to detect the six aforementioned biothreat pathogens within four hours providing clinicians with the needed information to appropriately treat infected patients.

NIH Awards Prenosis With Two Grants Totaling $4.8 million to Enable Precision Medicine for Sepsis

Retrieved on: 
Wednesday, July 12, 2023
Infection, Partnership, Society, Housing, Biomedical Advanced Research and Development Authority, Sepsis, Society of Critical Care Medicine, EMR, SBIR, TED (conference), National Institute of General Medical Sciences, Research, Electronic health record, Biomarker, American Thoracic Society, Development, Death, Hospital, Collection, Patient, Data, Machine learning, Algorithm, Medicine, Artificial intelligence, Biosafety, Biology, Mortality, American Association for Clinical Chemistry, WHO, NIGMS, BARDA, Medtech, NIH, MDDI, National Institutes of Health Clinical Center, Critical Care Medicine (journal), Pharmaceutical industry, Medical imaging, Nursing

CHICAGO, July 12, 2023 /PRNewswire/ -- Prenosis, Inc., an artificial intelligence company enabling precision medicine in acute care, announced today that it has been awarded two Phase 2 SBIR grants totaling $4.8M in funding by the National Institute of General Medical Sciences (NIGMS), a division of the National Institute of Health (NIH). The grants will study the use of Prenosis's Immunix™ Artificial Intelligence platform for acute immune states. Prenosis has built a collection of artificial intelligence algorithms, broad clinical data, deep biological data, and biobanked samples of patients suspected of sepsis, in addition to detailed information about their treatment regime. The goal is to better understand how patients' health states rapidly evolve in acute care environments.

Key Points: 
  • Prenosis has built a collection of artificial intelligence algorithms, broad clinical data, deep biological data, and biobanked samples of patients suspected of sepsis, in addition to detailed information about their treatment regime.
  • The goal is to better understand how patients' health states rapidly evolve in acute care environments.
  • The outcomes of these studies could usher in a new era of predictive diagnostics, clinical decision support tools, improved clinical trials, and precision medicine drugs for sepsis.
  • Prenosis generates deep biological profiles of each patient by measuring critical sepsis biomarkers in its Biological Safety Level 2 lab in Chicago.

Prenosis Inc. Receives BARDA Contract to Study Utility of Its Sepsis Diagnostic Tool

Retrieved on: 
Wednesday, June 7, 2023
Infection, ASPR, Partnership, Society, Biomedical Advanced Research and Development Authority, Housing, Office of Inspector General, U.S. Department of Health and Human Services, HHS, Sepsis, HBD, Society of Critical Care Medicine, EMR, TED (conference), Human services, Administration for Strategic Preparedness and Response, Research, Electronic health record, Biomarker, American Thoracic Society, Administration, Plasma, Development, Hospital, Data, Patient, Physician, Risk, Medicine, Cancer, Biosafety, Entrepreneurship, American Association for Clinical Chemistry, FDA, Health, BARDA, Medtech, MDDI, Critical Care Medicine (journal), Medical device, Medical imaging, Pharmaceutical industry

CHICAGO, June 7, 2023 /PRNewswire/ -- Prenosis Inc., an artificial intelligence company enabling precision medicine in acute care, announced today it has been awarded a contract from the Biomedical Advanced Research and Development Authority (BARDA), a component of the Administration for Strategic Preparedness and Response (ASPR), within the U.S. Department of Health and Human Services (HHS), a U.S. government agency.

Key Points: 
  • Prenosis has built a large, rapidly growing dataset and biobank from patients with sepsis and other infections.
  • By leveraging its proprietary dataset and AI/ML techniques, Prenosis is creating precision medicine solutions, starting with a sepsis diagnostic tool.
  • Prenosis' Sepsis ImmunoScore™ intends to enable true precision medicine for infection in hospitals.
  • The Sepsis ImmunoScore™ is a pathogen-agnostic, host-based digital diagnostic (HBD) that uses clinical parameters and protein biomarkers to assess a patient's risk of sepsis within 24 hours.

NAMSA Expands MedTech Portfolio in Market Intelligence and Customer Research Services through its Acquisition of EU-Based SUAZIO

Retrieved on: 
Monday, March 27, 2023
Science, Other Science, Data Analytics, Research, Health, Consulting, Medical Devices, Professional Services, Consultant, Multimedia, Acquisition, Biosafety, IVD, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Medtech, Food, Safety, Medical device, EU

NAMSA , a world-leading MedTech Contract Research Organization (CRO) offering global end-to-end development services, announced today its acquisition of SUAZIO , an EU-based strategic consultancy providing global market research services to medical device and IVD developers.

Key Points: 
  • NAMSA , a world-leading MedTech Contract Research Organization (CRO) offering global end-to-end development services, announced today its acquisition of SUAZIO , an EU-based strategic consultancy providing global market research services to medical device and IVD developers.
  • “NAMSA is very enthusiastic to expand its global strategic consulting services with the addition of SUAZIO,” commented Dr. Christophe Berthoux , NAMSA CEO.
  • “Client insights and precise market research are what power the true value of novel medical technologies and product acceptance.
  • With the SUAZIO Team, NAMSA will expand its Client reach even further and strengthen the delivery of its full continuum development services to the global MedTech industry,” Dr. Berthoux concluded.