Perfusion

3EO Health Announces the First Point of Care Molecular Test Under $15

Retrieved on: 
Thursday, March 28, 2024

3EO Health , a “Point of Life” diagnostics company focused on the development of high-performing low-cost molecular diagnostics, is excited to announce the next step in their quest to make molecular testing affordable.

Key Points: 
  • 3EO Health , a “Point of Life” diagnostics company focused on the development of high-performing low-cost molecular diagnostics, is excited to announce the next step in their quest to make molecular testing affordable.
  • View the full release here: https://www.businesswire.com/news/home/20240327647032/en/
    3EO high efficiency molecular 3TR technology enables testing to be executed in multiple settings and locations.
  • With a cost per test up to 70% lower than existing technologies, 3EO is seeking to create access to molecular technology for more physicians and consumers by providing molecular POC tests under $15.
  • 3EO Health received EUA authorization for its COVID-19 test utilizing 3TR technology in Q4 of 2023.

Near Infrared Imaging Market Projected to Reach $3.60 billion by 2030 - Exclusive Report by 360iResearch

Retrieved on: 
Monday, March 18, 2024

Near Infrared Imaging (NIRI) is transforming the landscape of non-invasive diagnostics with its capability to utilize wavelengths between 700 and 2500 nanometers, providing deep insights into biological tissues.

Key Points: 
  • Near Infrared Imaging (NIRI) is transforming the landscape of non-invasive diagnostics with its capability to utilize wavelengths between 700 and 2500 nanometers, providing deep insights into biological tissues.
  • The key players in the Near Infrared Imaging Market include Hamamatsu Photonics K.K., KARL STORZ SE & Co. KG, Olympus Corporation, Carl Zeiss AG, Shimadzu Corporation, and others.
  • We proudly unveil ThinkMi, a cutting-edge AI product designed to transform how businesses interact with the Near Infrared Imaging Market.
  • "Dive into the Near Infrared Imaging Market Landscape: Explore 186 Pages of Insights, 558 Tables, and 22 Figures"

Near Infrared Imaging Market Projected to Reach $3.60 billion by 2030 - Exclusive Report by 360iResearch

Retrieved on: 
Monday, March 18, 2024

Near Infrared Imaging (NIRI) is transforming the landscape of non-invasive diagnostics with its capability to utilize wavelengths between 700 and 2500 nanometers, providing deep insights into biological tissues.

Key Points: 
  • Near Infrared Imaging (NIRI) is transforming the landscape of non-invasive diagnostics with its capability to utilize wavelengths between 700 and 2500 nanometers, providing deep insights into biological tissues.
  • The key players in the Near Infrared Imaging Market include Hamamatsu Photonics K.K., KARL STORZ SE & Co. KG, Olympus Corporation, Carl Zeiss AG, Shimadzu Corporation, and others.
  • We proudly unveil ThinkMi, a cutting-edge AI product designed to transform how businesses interact with the Near Infrared Imaging Market.
  • "Dive into the Near Infrared Imaging Market Landscape: Explore 186 Pages of Insights, 558 Tables, and 22 Figures"

Syngene biologics manufacturing facility to be operational for US and European customers from mid-year

Retrieved on: 
Thursday, March 14, 2024

BANGALORE, India, March 14, 2024 /PRNewswire/ -- At DCAT 2024 global bio/pharmaceutical manufacturing forum, Syngene International, a global contract research, development and manufacturing organization (CRDMO), will announce that its newly upgraded biologics facility - Unit 3 - would be operational for clinical and commercial supply in the second half of 2024.

Key Points: 
  • The facility will be available for biotech and pharma customers seeking drug substance and drug product contract manufacturing.
  • The Company also has a microbial cGMP facility and a mammalian cell manufacturing facility to extend end-to-end Chemistry, Manufacturing and Control (CMC) development solutions for its global clients.
  • The integration of chromatography systems streamlines the purification processes and enhances the overall efficiency of biologics manufacturing.
  • In total Unit 3 will have around 100 staff for Quality Assurance and Manufacturing, part of Syngene's 600-strong team across its biologics manufacturing services and supporting specialist functions.

Syngene biologics manufacturing facility to be operational for US and European customers from mid-year

Retrieved on: 
Thursday, March 14, 2024

BANGALORE, India, March 14, 2024 /PRNewswire/ -- At DCAT 2024 global bio/pharmaceutical manufacturing forum, Syngene International, a global contract research, development and manufacturing organization (CRDMO), will announce that its newly upgraded biologics facility - Unit 3 - would be operational for clinical and commercial supply in the second half of 2024.

Key Points: 
  • The facility will be available for biotech and pharma customers seeking drug substance and drug product contract manufacturing.
  • The Company also has a microbial cGMP facility and a mammalian cell manufacturing facility to extend end-to-end Chemistry, Manufacturing and Control (CMC) development solutions for its global clients.
  • The integration of chromatography systems streamlines the purification processes and enhances the overall efficiency of biologics manufacturing.
  • In total Unit 3 will have around 100 staff for Quality Assurance and Manufacturing, part of Syngene's 600-strong team across its biologics manufacturing services and supporting specialist functions.

Clinical Research on Photon-Counting CT Begins with Radboud University Medical Center

Retrieved on: 
Tuesday, February 27, 2024

Otawara, Japan, Feb. 27, 2024 (GLOBE NEWSWIRE) -- Canon Medical Systems Corporation (hereinafter "Canon Medical"; President and CEO: Toshio Takiguchi; headquarters: Otawara, Tochigi, Japan) has completed the second installation of its Canon photon-counting CT (PCCT) system worldwide at Radboud University Medical Center (Chair: Dr. Bertine Lahuis; location: Nijmegen, the Netherlands), and clinical research began in late January.

Key Points: 
  • Otawara, Japan, Feb. 27, 2024 (GLOBE NEWSWIRE) -- Canon Medical Systems Corporation (hereinafter "Canon Medical"; President and CEO: Toshio Takiguchi; headquarters: Otawara, Tochigi, Japan) has completed the second installation of its Canon photon-counting CT (PCCT) system worldwide at Radboud University Medical Center (Chair: Dr. Bertine Lahuis; location: Nijmegen, the Netherlands), and clinical research began in late January.
  • PCCT is expected to be the next generation of X-ray CT
    Radboud University Medical Center is an academic medical center specializing in patient care, scientific research, teaching, and training.
  • The Department of Radiology at Radboud University Medical Center leads one of the best research groups in Europe, working with more than 150 researchers on advanced studies to provide patient care and improve health care.
  • Canon Medical entered into an agreement on joint clinical research with Radboud University Medical Center on November 14, 2023,*1 and clinical research aimed at early practical application of PCCT was started, led by Prof. Mathias Prokop, Chairman of the Department of Radiology at Radboud University Medical Center.

BMI OrganBank, Atrium Health and LifeShare Carolinas Partner to Launch Nation's First Organ Banking Technology

Retrieved on: 
Thursday, February 22, 2024

BMI OrganBank™ is developing novel organ perfusion systems with potential to greatly reduce the waitlist for lifesaving organ transplants.

Key Points: 
  • BMI OrganBank™ is developing novel organ perfusion systems with potential to greatly reduce the waitlist for lifesaving organ transplants.
  • Partnership includes early access to BMI technologies, collaboration on product design, clinical studies, clinical integration pilots and an undisclosed capital arrangement.
  • CHARLOTTE, N.C., Feb. 22, 2024 /PRNewswire/ -- Atrium Health's Division of Abdominal Transplant, Carolinas Medical Center (DAT Atrium), LifeShare Carolinas, one of nation's leading Organ Procurement Organizations, and BMI OrganBank, a developer of organ perfusion systems based in Winston-Salem, North Carolina, announced today that their organizations have partnered to develop and launch the nation's first Organ Banking technology, which will greatly expand the possibilities for organ preservation and reconditioning.
  • With this partnership, DAT Atrium and LifeShare Carolinas will be the first clinical organizations to have access to this technology.

Reflection paper on investigation of pharmacokinetics in the obese population - Scientific guideline

Retrieved on: 
Wednesday, February 14, 2024

Reflection paper on investigations of pharmacokinetics in

Key Points: 
    • Reflection paper on investigations of pharmacokinetics in
      the obese population
      Table of contents
      1.
    • References .............................................................................................. 9

      Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

      Page 2/12

      1.

    • This is considered
      a shortcoming that is potentially compounded by obese patients often being poorly represented in
      clinical studies.
    • The specific aims of this reflection paper are to:
      ?

      describe how the effects of obesity can be investigated during clinical medicinal product
      development.

    • ?

      provide recommendations on when investigations of the effect of obesity on the PK of a
      medicinal product should be particularly considered.

    • Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

      Page 3/12

      ?

      discuss how to reflect PK (and/or PK/PD) findings in weight/weight-based dosing
      recommendations.

    • Absorption
      Reduced rate of absorption linked to locally reduced blood flow (8) is reported for the subcutaneous
      and transdermal routes in obese subjects.
    • Distribution
      The distribution of medicinal products is driven by body composition, regional blood flow and binding to
      tissue and plasma proteins.
    • Obese subjects have a larger absolute lean body weight (LBW) as well as fat mass.
    • The physicochemical properties of a medicinal product (lipophilicity, polarity, molecular size, and
      degree of ionization) influence its distribution in the body.
    • In BMI class III obese
      subjects, the blood flow per gram of fat is significantly lower than that observed in class I obese or
      lean subjects (4).
    • Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

      Page 4/12

      An increased amount of alpha-1-acid-glycoprotein (AAG), linked to a chronic inflammatory state, is
      reported in obese individuals.

    • Fatty infiltrations are present in the liver for 90% of obese subjects, with the extent of the infiltrations
      being proportional to the degree of obesity.
    • In some cases, in particular for CYP3A4 metabolized medicinal products,
      bodyweight normalized clearance can be lower in obese patients (23).
    • Based on presently available data, it has been suggested that uptake transporters

      Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

      Page 5/12

      are downregulated while efflux transporters may be upregulated (31).

    • Platelet hyper-reactivity is also observed,
      which can impair the response to anti-platelet medicinal products in obese patients (42, 43).
    • Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

      Page 6/12

      3.

      the medicinal product properties and scientific literature indicate that obesity may lead to a
      marked effect on elimination and/or distribution or on the PK/PD relationship.

    • These
      models may aid in extrapolating the known efficacy and safety in the non-obese population to the
      obese population.
    • The Pharmacokinetics of the CYP3A Substrate Midazolam in Morbidly Obese Patients
      Before and One Year After Bariatric Surgery.
    • Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

      Page 11/12

      41.

    • Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

      Page 12/12

RapidAI Announces Late-Breaking Abstract Simultaneously Published in NEJM; Highlights Key Data Revealed at ISC 2024

Retrieved on: 
Monday, February 12, 2024

Data Summaries from Key Studies:

Key Points: 
  • Data Summaries from Key Studies:
    Subgroup Analyses from the TIMELESS Trial, by Gregory Albers, M.D., presented and simultaneously published in the NEJM.
  • Key imaging criteria: target mismatch ratio of ≥1.8, mismatch volume of ≥15 mL, and ischemic core volume
  • Data showed a median reduction of 30 minutes per patient from door-to-mechanical thrombectomy (MT) after the integration of RapidAI.
  • “In the world of AI, clinical validation is paramount to instill confidence in clinician decision-making,” said Karim Karti, CEO of RapidAI.

New Peer-Reviewed Study Finds That Masimo SET® Pulse Oximetry Measures Accurately on Both Black and White People Even During Low Perfusion

Retrieved on: 
Thursday, February 8, 2024

Barker and Wilson analyzed Masimo laboratory data obtained from self-identified Black and White volunteer subjects to evaluate differences in Masimo pulse oximetry accuracy and bias on the basis of skin tone.

Key Points: 
  • Barker and Wilson analyzed Masimo laboratory data obtained from self-identified Black and White volunteer subjects to evaluate differences in Masimo pulse oximetry accuracy and bias on the basis of skin tone.
  • To that end, they abstracted Pi values from their dataset, and divided them into “low perfusion” (Pi ≤ 1) and “normal perfusion” (Pi > 1) groups.
  • For the subset of Black subjects, there was bias and precision of -0.26% ± 1.37%, and for White subjects, -0.12% ± 1.31%.
  • In the low perfusion group, there was overall bias and precision of 0.48% ± 1.59%, with accuracy of 1.64% ARMS.