Pulmonary embolism

AngioDynamics’ APEX-AV Trial Results Assessing AlphaVac F18⁸⁵ System in Treatment of Pulmonary Embolism Presented at SCAI 2024 Scientific Sessions

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星期一, 五月 6, 2024
Research, Medical Devices, FDA, Hospitals, Clinical Trials, Cardiology, Biotechnology, Health, Science, UCLA, Patient, Cancer, Bleeding, The Society, Assistant professor, Safety, IDE, Partnership, PERT, Pulmonary embolism, Acute, Associate, APEX, SCAI, Interventional radiology, Pharmaceutical industry

“Pulmonary emboli can be extremely dangerous and require effective and prompt action.

Key Points: 
  • “Pulmonary emboli can be extremely dangerous and require effective and prompt action.
  • In April 2024, the United States Food and Drug Administration (FDA) cleared the AlphaVac F1885 System for the treatment of PE.
  • “The results of the trial highlight the unique features of the AlphaVac device,” said Juan Carlos Serna, AngioDynamics Senior Vice President of Scientific and Clinical Affairs.
  • The primary efficacy endpoint of the APEX-AV trial was the reduction in RV/LV ratio between baseline and 48 hours post-procedure.

SonoVascular Enters into Strategic Collaboration with Lantheus Holdings, Inc. for Use of Microbubbles in Combination with SonoThrombectomy™ System for Treatment of Venous Thromboembolism

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星期四, 五月 2, 2024
Safety, VTE, FIH, Partnership, Pulmonary embolism, Patient, DVT, Catheter, Microbubble, Vein, Coronary thrombosis, Deep vein thrombosis

VTE is a condition that occurs when a blood clot forms in a deep vein, resulting in DVT.

Key Points: 
  • VTE is a condition that occurs when a blood clot forms in a deep vein, resulting in DVT.
  • The microbubbles are activated by intravascular ultrasound and will be investigated in ongoing pre-clinical and upcoming clinical studies.
  • The SonoThrombectomy System has been engineered to address and overcome the deficiencies and limitations of current interventional devices.
  • Additionally, upon completion of a FIH study, SonoVascular has an option to enter into a long-term exclusive commercial supply agreement with Lantheus.

Cytovale's Diagnostic Test Demonstrates Strong Performance in Rapid Identification of Sepsis Risk, Peer-Review Study Confirms

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星期四, 五月 2, 2024
Septic, Emergency department, FDA, Academic Emergency Medicine, Critical care, Risk, Hospital, Food, Research, Triage, Length of stay, Pulmonary embolism, Patient, EDS, Hospice and palliative medicine, Medical director, ED, Food and Drug Administration, SAN, Sepsis, Infection, Nursing

SAN FRANCISCO, May 2, 2024 /PRNewswire/ -- Cytovale®, a commercial-stage medical diagnostics company focused on advancing early detection technologies to diagnose fast-moving and immune-mediated diseases, today announced the publication of a new peer reviewed-study in "Academic Emergency Medicine'' that demonstrates strong diagnostic performance of the company's IntelliSep® host response test for sepsis detection. The study analyzed 1,002 patients and evaluated the accuracy of IntelliSep to rapidly diagnose patients with sepsis and help clinicians expedite appropriate care.

Key Points: 
  • The study analyzed 1,002 patients and evaluated the accuracy of IntelliSep to rapidly diagnose patients with sepsis and help clinicians expedite appropriate care.
  • The test provides critical new information about immune activation and sepsis risk stratification through a simple blood draw in about 8 minutes.
  • IntelliSep was evaluated for accurately diagnosing sepsis and providing a rapid, objective tool for determining the risk and severity of sepsis in these patients.
  • The test showed similar 'rule-in' performance to other critical ED tests, with a Positive Predictive Value of 55%.

Viz.ai Wins 2024 Edison Award™ for Innovation for Second Year in a Row

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星期五, 四月 19, 2024
Cardiology, Biotechnology, Technology, Other Health, Health, General Health, Optical, Health Technology, Infectious Diseases, Software, Artificial Intelligence, Education, Mortality, FDA, AI, AVF, Triage, American Lung Association, Partnership, Artificial intelligence, Pulmonary embolism, Assessment, Engineering, Science, PERT, Edison Award, Edison Awards, Circulatory system, Thomas Edison, Multimedia, Marketing, Diagnosis, Viz

Viz.ai, the leader in AI-powered disease detection and intelligent care coordination, today announced that it has been named an Edison Award Winner in the 2024 Edison Awards, for the second year in a row.

Key Points: 
  • Viz.ai, the leader in AI-powered disease detection and intelligent care coordination, today announced that it has been named an Edison Award Winner in the 2024 Edison Awards, for the second year in a row.
  • The prestigious Edison Awards, named after the American inventor Thomas Alva Edison, honor excellence in new product and service development, marketing, design and innovation.
  • View the full release here: https://www.businesswire.com/news/home/20240419954371/en/
    “We are honored to win our second Edison Award for innovation,” said Dr. Chris Mansi, CEO and co-founder of Viz.ai.
  • Winners were announced at the Edison Awards Gala on April 18, 2024 in Fort Myers, FL.

National Blood Clot Alliance Names Corewell Health a Center of Excellence

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星期三, 四月 10, 2024
Education, Patient, Hospital, VTE, Certification, NBCA, COE, Butterworth Hospital, Pulmonary embolism, Survivor, DVT, National Blood Clot Alliance, Health, Deep vein thrombosis, Coronary thrombosis, Nursing

PHILADELPHIA, April 10, 2024 /PRNewswire/ -- National Blood Clot Alliance ® (NBCA) today announced that Corewell Health™ Grand Rapids Hospitals – Butterworth Hospital has been named the inaugural NBCA Center of Excellence in the United States.

Key Points: 
  • PHILADELPHIA, April 10, 2024 /PRNewswire/ -- National Blood Clot Alliance ® (NBCA) today announced that Corewell Health™ Grand Rapids Hospitals – Butterworth Hospital has been named the inaugural NBCA Center of Excellence in the United States.
  • By designating Corewell Health a Center of Excellence, we are acknowledging its commitment to both clinical excellence and patient education," said Board Member and NBCA Committee Chair Justin Crockett.
  • In designating Corewell Health as an NBCA Center of Excellence, the committee highlighted both the qualitative and quantitative multidisciplinary, systematic approach to DVT and PE treatment.
  • "This formal recognition speaks highly of the demonstrated excellence of Corewell Health's program treating patients with acute and chronic VTE," said Alejandro Quiroga, M.D., president, Corewell Health in West Michigan.

Inari Medical Announces Interim Two-Year Results from the ClotTriever CLOUT Registry

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星期二, 三月 12, 2024
Deep vein thrombosis, Pulmonary embolism, VTE, Incidence, Sequela, CAVA, Patient, Post-thrombotic syndrome, Research, PTS, DVT, Randomized controlled trial, Safety, FACS, American Venous Forum, Data, Pharmaceutical industry

IRVINE, Calif., March 12, 2024 (GLOBE NEWSWIRE) -- Inari Medical, Inc. (NASDAQ: NARI) (“Inari”) a medical device company focused on developing products to treat and transform the lives of patients suffering from venous and other diseases, announced positive two-year interim results from the CLOUT registry.

Key Points: 
  • IRVINE, Calif., March 12, 2024 (GLOBE NEWSWIRE) -- Inari Medical, Inc. (NASDAQ: NARI) (“Inari”) a medical device company focused on developing products to treat and transform the lives of patients suffering from venous and other diseases, announced positive two-year interim results from the CLOUT registry.
  • The interim results are the largest prospective, multi-center two-year dataset in deep vein thrombosis (DVT) since the ATTRACT trial and confirm the excellent safety, effectiveness, and long-term outcomes of the ClotTriever system in real-world DVT patients.
  • Patients had low incidence of independently adjudicated safety events related to rethrombosis, with only 5.0% and 8.4% at 30-days and 6 months, respectively.
  • We remain committed to establishing the ClotTriever and FlowTriever systems as standard of care for deep vein thrombosis and pulmonary embolism (PE) patients.”

AngioDynamics Receives 510(k) Clearance for AlphaVac F1885 System in Treatment of PE

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星期四, 四月 4, 2024
Research, Medical Devices, Surgery, FDA, Cardiology, General Health, Health, Science, Oncology, Other Science, Interventional radiology, RV, Pulmonary embolism, Thrombus, Associate, Partnership, Cannula, Patient, PERT, Cancer, APEX, Assistant professor, Bleeding, Safety, UCLA, Embolism, Pharmaceutical industry

The expanded FDA indication allows for the utilization of the AlphaVac F1885 System for the treatment of PE, which broadens the applicability of the AlphaVac F1885 System in the non-surgical removal of thrombi or emboli from the venous vasculature.

Key Points: 
  • The expanded FDA indication allows for the utilization of the AlphaVac F1885 System for the treatment of PE, which broadens the applicability of the AlphaVac F1885 System in the non-surgical removal of thrombi or emboli from the venous vasculature.
  • The indication expands treatment options for patients with PE, reducing thrombus burden and improving right ventricular function.
  • “The addition of the AlphaVac System in the mechanical thrombectomy world is a critical step forward in the treatment of PE patients,” said Dr. Keeling.
  • “The 510(k) clearance of the AlphaVac System represents an important milestone towards the treatment of PE,” said Mona Ranade, MD, Assistant Professor, Interventional Radiology, at the David Geffen School of Medicine at UCLA.

AngioDynamics Reports Fiscal Year 2024 Third Quarter Financial Results; Updates Fiscal Year 2024 Guidance to Reflect Asset Divestiture

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星期四, 四月 4, 2024
Health, Oncology, Cardiology, Medical Devices, Radio, MED, Dialysis, Pulmonary embolism, Growth, Patient, News, Nanoknife, Cancer, Public expenditure, Table, APEX, Quality of life, PICC, Radiofrequency ablation, IP, GAAP, Patent, Starburst, FDA, Medical laboratory scientist, Pharmaceutical industry

Net sales for the third quarter of fiscal year 2024 were $66.0 million, an increase of 8.0% compared to the prior-year quarter.

Key Points: 
  • Net sales for the third quarter of fiscal year 2024 were $66.0 million, an increase of 8.0% compared to the prior-year quarter.
  • U.S. net sales in the third quarter of fiscal 2024 were $55.8 million, an increase of 5.9% from sales of $52.7 million a year ago.
  • GAAP reported gross margin was 47.7%, a decrease of 250 basis points compared to the third quarter of fiscal 2023.
  • On a pro forma basis, gross margin for the third quarter of fiscal 2024 was 51.1%, a decline of 290 basis points from the third quarter of fiscal 2023.

Viz.ai Broadens Healthcare System Integrations to Inform Critical Decisions at the Point of Care

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星期二, 三月 12, 2024
Data Management, Biotechnology, Technology, Health, General Health, Health Technology, Software, Artificial Intelligence, Networks, Internet, Mobile, Wireless, Pulmonary embolism, Algorithm, Good Samaritan Hospital, Disease, Patient, Intensive care unit, AI, MD, Viz, Workflow, FCCP, EHR, PACS, Multimedia, Physician, Medical imaging

Viz.ai, the leader in AI-powered disease detection and intelligent care coordination, today announced expanded interoperability capabilities of Viz.ai One.

Key Points: 
  • Viz.ai, the leader in AI-powered disease detection and intelligent care coordination, today announced expanded interoperability capabilities of Viz.ai One.
  • Viz.ai algorithms and electronic health record (EHR) data work together on one platform to detect suspected disease and communicate results to care teams immediately.
  • These collaborative integrations streamline clinical workflows and help physicians diagnose and treat patients faster to improve patient outcomes.
  • “Viz.ai’s direct integrations provide more context and relevant patient information to clinicians wherever they are, helping to save more time at the point-of-care and increase efficiency.”

Avicenna.AI secures FDA clearance for two healthcare AI solutions

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星期二, 三月 26, 2024
Avicenna, Pulmonary embolism, Brain, Algorithm, Radiology, La Ciotat, NCCT, Pelvis, Radiodensity, Stroke, Abdomen, Mortality, Triage, AI, Aortic dissection, CINA, Deep learning, Google Images, Intracranial hemorrhage, Machine learning, Probability, FDA, Physician, Health, Embolism, Food, Medical imaging

La Ciotat, FRANCE, March 26, 2024 /PRNewswire/ -- Medical imaging AI company Avicenna.AI today announced that it has received 510(k) clearance from the US Food and Drug Administration for its CINA-iPE and CINA-ASPECTS products. Using a combination of deep learning and machine learning technologies, the company develops AI solutions that automatically detect and prioritize life-threatening conditions within seconds, assess them for severity, and seamlessly notify clinicians.

Key Points: 
  • La Ciotat, FRANCE, March 26, 2024 /PRNewswire/ -- Medical imaging AI company Avicenna.AI today announced that it has received 510(k) clearance from the US Food and Drug Administration for its CINA-iPE and CINA-ASPECTS products.
  • Using a combination of deep learning and machine learning technologies, the company develops AI solutions that automatically detect and prioritize life-threatening conditions within seconds, assess them for severity, and seamlessly notify clinicians.
  • CINA-iPE and CINA-ASPECTS are the latest tools from Avicenna.AI to secure FDA clearance, joining its AI solutions for medical emergencies, including automatic detection of intracranial hemorrhage (CINA-ICH), large vessel occlusion (CINA-LVO), aortic dissection (CINA-AD), pulmonary embolism (CINA-PE) from CT-scan imaging.
  • "The clearance of CINA-iPE and CINA-ASPECTS marks a significant milestone in our mission to strive for excellence in advancing patient care.