HDE

PwC and Google Cloud Announce Strategic Collaboration to Accelerate Enterprise Adoption of Vertex AI and Gemini Models

Retrieved on: 
Tuesday, April 9, 2024

LONDON, April 9, 2024 /PRNewswire/ -- Cloud Next '24, LAS VEGAS -- PwC today announced an expansion of its strategic alliance with Google Cloud to enhance how businesses operate with generative AI (gen AI). PwC will build new solutions and industry use cases that help enhance how global organizations function and accelerate time-to-value from AI investments, leveraging the power of Google Cloud's AI-optimized infrastructure and Gemini models. PwC will also apply Google Cloud's gen AI technology to its own business practices to improve complex and time-consuming processes, specifically in the legal and tax domains.

Key Points: 
  • With Google's enterprise AI platform, Vertex AI, and its Gemini models, PwC will help customers set new benchmarks for digital transformation and improve their businesses for growth and efficiency.
  • "Through our strategic alliance with Google Cloud, we are helping companies realize value from their gen AI investments to reinvent how they do business.
  • By leveraging our gen AI solution built on Google Cloud's Vertex AI platform, PwC can better support digital and business transformations."
  • PwC and Google Cloud also launched a Gen AI Innovation Lab to more quickly scope, build, and deploy gen AI use cases powered by Gemini models and Google Cloud's full portfolio of AI technology.

SeaStar Medical Provides Updates on Enrollment of Adult Pivotal Clinical Study and Commercial Launch of Quelimmune, FDA-Approved in Pediatric Patients

Retrieved on: 
Tuesday, March 12, 2024

DENVER, March 12, 2024 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial stage medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, provides updates on the acute kidney injury (AKI) programs it is developing with its patented, first-to-market, cell-directed Selective Cytopheretic Device (SCD) extracorporeal therapy in critically ill patients with AKI.

Key Points: 
  • “We now have 21 subjects enrolled across five clinical sites in our NEUTRALIZE-AKI pivotal clinical trial, which is intended to evaluate the safety and efficacy of our SCD in adult AKI patients.
  • Additional sites are progressing through the site activation and contract completion process,” said Kevin Chung, MD, Chief Medical Officer of SeaStar Medical.
  • “We expect the pace of enrollment will accelerate as more medical centers come onboard.
  • With the Approval Order, SeaStar Medical can build Quelimmune Clinical Kits into inventory in parallel to the hospital approvals process.

Google Cloud Announces New Generative AI Advancements for Healthcare and Life Science Organizations

Retrieved on: 
Tuesday, March 12, 2024

ORLANDO, Fla., March 12, 2024 /PRNewswire/ -- Today at HIMSS24, Google Cloud announced several new solutions to help healthcare and life sciences organizations enable interoperability, build a better data foundation for their businesses, and deploy generative AI (gen AI) tools to improve patient outcomes.

Key Points: 
  • These search and question-answering capabilities now integrate with MedLM , Healthcare Data Engine (HDE) and Cloud Healthcare FHIR APIs , making it easier for healthcare and life science organizations to build the data analytics and AI solutions needed for next era health systems.
  • Configurable cloud APIs: Healthcare application developers can integrate the medically-tuned search directly into the clinician workflow tools using configurable cloud APIs.
  • "Not all generative AI is created equal, and in healthcare, the stakes are particularly high," said Aashima Gupta, global director for Healthcare Strategy & Solutions, Google Cloud.
  • For more information on these technology advancements for healthcare and life sciences, stop by the Google booth #2512 at HIMSS24 , and please contact your Google Cloud sales team to learn more.

FDA Grants Humanitarian Device Exemption Approval to SeaStar Medical’s Selective Cytopheretic Device for Pediatric Acute Kidney Injury

Retrieved on: 
Thursday, February 22, 2024

DENVER, Feb. 22, 2024 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, announces that the U.S. Food and Drug Administration (FDA) has granted a Humanitarian Device Exemption (HDE) Approval Order to the Selective Cytopheretic Device (SCD) Pediatric (SCD-PED) for use in children weighing 10 kilograms or more with acute kidney injury (AKI) due to sepsis or a septic condition requiring kidney replacement therapy (KRT). This is the first product in the Company’s newly branded Quelimmune product family, and the Quelimmune pediatric device can now be commercially marketed as a Humanitarian Use Device (HUD).

Key Points: 
  • This is the first product in the Company’s newly branded Quelimmune product family, and the Quelimmune pediatric device can now be commercially marketed as a Humanitarian Use Device (HUD).
  • In clinical studies, Quelimmune for pediatric AKI has been shown to reduce mortality rates and dialysis dependency in clinical studies.
  • “We appreciate the FDA’s willingness to work collaboratively with SeaStar Medical and our advisors to grant HDE approval to Quelimmune for pediatric use,” Mr. Schlorff added.
  • SeaStar Medical is currently focused on its NEUTRALIZE-AKI pivotal clinical trial to evaluate Quelimmune therapy in the larger adult AKI population, while exploring other applications for this device.

Nuwellis’ Distribution Partner, SeaStar Medical, Receives FDA Humanitarian Device Exemption for Pediatric Selective Cytopheretic Device Quelimmune™

Retrieved on: 
Thursday, February 22, 2024

MINNEAPOLIS, Feb. 22, 2024 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company focused on transforming the lives of people with fluid overload, today announced its distribution partner, SeaStar Medical Holding Corporation (Nasdaq: ICU) (SeaStar Medical), has received Humanitarian Device Exemption (HDE) from the U.S. Food and Drug Administration (FDA) for Quelimmune™, its pediatric Selective Cytopheretic Device.

Key Points: 
  • MINNEAPOLIS, Feb. 22, 2024 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company focused on transforming the lives of people with fluid overload, today announced its distribution partner, SeaStar Medical Holding Corporation (Nasdaq: ICU) (SeaStar Medical), has received Humanitarian Device Exemption (HDE) from the U.S. Food and Drug Administration (FDA) for Quelimmune™, its pediatric Selective Cytopheretic Device.
  • Nuwellis has an exclusive U.S. license and distribution agreement with SeaStar Medical to distribute Quelimmune and will market and distribute the device to nephrologists and intensive care physicians who are trained in pediatric extracorporeal therapy.
  • “The pediatric segment of our business has gained significant traction since the 2020 FDA clearance of our Aquadex device for pediatric patients weighing 20kg or more – growing at a compound annual growth rate (CAGR) of over 30%.
  • Clinical studies have demonstrated Quelimmune’s potential to eliminate dialysis dependency, shorten intensive care unit time, and restore the lives of critically ill pediatric patients.

ESO Appoints Joy Brown to Board of Directors

Retrieved on: 
Wednesday, February 14, 2024

ESO , a leading data and software company serving emergency medical services (EMS), fire departments, hospitals, state, and federal systems, is pleased to announce the appointment of Joy Brown to its Board of Directors.

Key Points: 
  • ESO , a leading data and software company serving emergency medical services (EMS), fire departments, hospitals, state, and federal systems, is pleased to announce the appointment of Joy Brown to its Board of Directors.
  • View the full release here: https://www.businesswire.com/news/home/20240214700821/en/
    ESO is pleased to announce the appointment of Joy Brown to its Board of Directors.
  • As the leading provider of software for emergency services, ESO is uniquely positioned to provide data and insights to emergency service providers striving to improve patient outcomes,” said Joy Brown.
  • ESO (ESO Solutions, Inc.) is dedicated to improving community health and safety through the power of data.

Atropos Health Redefines Data Quality With Two Scoring Metrics, Bridging The Gap For Transparent Evaluation of Data Use In Evidence and Prediction Generation

Retrieved on: 
Tuesday, February 13, 2024

Existing literature identifies two gaps in data grading: the need for quantitative data grading scores and scoring mechanisms that can be run in an automated fashion and at scale.

Key Points: 
  • Existing literature identifies two gaps in data grading: the need for quantitative data grading scores and scoring mechanisms that can be run in an automated fashion and at scale.
  • Atropos Health solves this with its transparent methodology:
    The RWDS rates a dataset's overall quality and completeness across a range of metrics.
  • Atropos Health provides both RWDS and RWFS/FitQ to guide users to appropriate data sources for analysis.
  • Across the growing Atropos Evidence™ Network, users can now evaluate which dataset may be most appropriate for their given query.

Atropos Health Leverages Google Cloud to Generate Actionable Clinical Evidence for Healthcare Institutions from Healthcare Data, Rapidly and Securely

Retrieved on: 
Tuesday, January 30, 2024

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20240130637982/en/
    With Google Cloud and Atropos Health, health systems can spend less time maintaining infrastructure and more time leveraging insights from their data for improved operational efficiency and clinical decision making.
  • "Atropos Health is committed to enabling rapid real-world evidence with the highest levels of data privacy and security in healthcare.
  • Atropos Health's services facilitate secure access to real-world evidence, in compliance with regulations like HIPAA," said Dr. Brigham Hyde, CEO and co-founder of Atropos Health.
  • “We look forward to working with Atropos Health to drive impactful innovation and improve healthcare for everyone.”

SeaStar Medical Updates Subject Enrollment in its Pivotal Trial with the Selective Cytopheretic Device in Adults with Acute Kidney Injury

Retrieved on: 
Thursday, December 28, 2023

DENVER, Dec. 28, 2023 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, announces enrollment of 12 subjects in the NEUTRALIZE-AKI pivotal clinical trial evaluating the safety and efficacy of its patented, first-in-class, cell-directed Selective Cytopheretic Device (SCD) extracorporeal therapy in critically ill adults with acute kidney injury (AKI) requiring continuous kidney replacement therapy (CKRT).

Key Points: 
  • DENVER, Dec. 28, 2023 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, announces enrollment of 12 subjects in the NEUTRALIZE-AKI pivotal clinical trial evaluating the safety and efficacy of its patented, first-in-class, cell-directed Selective Cytopheretic Device (SCD) extracorporeal therapy in critically ill adults with acute kidney injury (AKI) requiring continuous kidney replacement therapy (CKRT).
  • “Over the past six weeks we have enrolled five subjects in this clinical trial while also continuing progress in activating additional clinical sites,” said Kevin Chung, MD, Chief Medical Officer of SeaStar Medical.
  • “We are grateful to the dedicated investigators and their research staff who are working diligently to help validate the efficacy and safety of the SCD in this vulnerable population.”
    “We look forward to providing periodic updates on patient enrollment and site activations as this important trial progresses,” said Eric Schlorff, CEO of SeaStar Medical.
  • “We believe the more than 200,000 U.S. adult patients each year with AKI who require CKRT deserve a better treatment option.

SeaStar Medical Forms Scientific Advisory Board of World-Renowned Pediatric and Adult Clinical Experts

Retrieved on: 
Wednesday, December 13, 2023

DENVER, Dec. 13, 2023 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a medical device company developing proprietary solutions to reduce the consequences of dysregulated immune responses including hyperinflammation on vital organs, announces the formation of the SeaStar Medical Scientific Advisory Board (SAB).

Key Points: 
  • DENVER, Dec. 13, 2023 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a medical device company developing proprietary solutions to reduce the consequences of dysregulated immune responses including hyperinflammation on vital organs, announces the formation of the SeaStar Medical Scientific Advisory Board (SAB).
  • The SAB is comprised of world-renowned international pediatric and adult clinical experts including nephrologists, critical care intensivists and translational scientists who will advise on the Company’s technology capabilities, share insights on emerging trends in healthcare, and advise on the Company’s critical care and acute kidney injury (AKI) clinical development programs.
  • “Science and innovation are the foundational pillars of SeaStar Medical and key to our competitive advantage,” said Eric Schlorff, CEO of SeaStar Medical.
  • “The advisory board also advised on design elements of our ongoing, pivotal NEUTRALIZE-AKI Phase 3 study with the SCD in adult patients with AKI.