Pulmonary embolism

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

Retrieved on: 
Tuesday, March 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

Retrieved on: 
Thursday, April 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

Retrieved on: 
Thursday, April 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

Retrieved on: 
Tuesday, March 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

Retrieved on: 
Tuesday, March 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.

Avicenna.AI secures FDA clearance for two healthcare AI solutions

Retrieved on: 
Tuesday, March 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.

MemorialCare Saddleback Medical Center Awarded Patient Safety Excellence Award from Healthgrades for the First Time

Retrieved on: 
Friday, March 22, 2024
Hospital, Healthgrades, Deep vein thrombosis, Pulmonary embolism, Organization, PSI, Patient, Safety, Patient safety, PSIS, Pressure ulcer, Physician, Nursing

LAGUNA HILLS, Calif., March 22, 2024 /PRNewswire/ -- MemorialCare Saddleback Medical Center was awarded the 2024 Patient Safety Excellence Award™ by Healthgrades , the leading resource that connects consumers, physicians and health systems.

Key Points: 
  • LAGUNA HILLS, Calif., March 22, 2024 /PRNewswire/ -- MemorialCare Saddleback Medical Center was awarded the 2024 Patient Safety Excellence Award™ by Healthgrades , the leading resource that connects consumers, physicians and health systems.
  • This award recognizes the top 10% of hospitals in the nation for patient safety.
  • "It is an honor to be named one of the top 10% of hospitals for patient safety for the first time," says Marcia Manker, chief executive officer, MemorialCare Saddleback Medical Center.
  • MemorialCare Saddleback Medical Center qualified for this recognition when it was named one of America's 250 Best Hospitals by Healthgrades in 2023.

New Viz.ai Study Demonstrates Reduced Mortality Rates in Patients with Pulmonary Embolism

Retrieved on: 
Thursday, March 7, 2024
Software, General Health, Professional Services, Data Management, Medical Devices, Technology, Infectious Diseases, Hospitals, Artificial Intelligence, Health Technology, Data Analytics, Health, Viz, Pulmonary embolism, Multimedia, AI, AVF, Assessment, TriHealth, Mortality, American Venous Forum, PERT, Medical device

Viz.ai, the leader in AI-powered disease detection and intelligent care coordination, today announced clinical data validating the impact of the Viz PE Solution in the management and outcomes of patients with pulmonary embolism (PE).

Key Points: 
  • Viz.ai, the leader in AI-powered disease detection and intelligent care coordination, today announced clinical data validating the impact of the Viz PE Solution in the management and outcomes of patients with pulmonary embolism (PE).
  • The data was presented during the 2024 AVF (American Venous Forum) by Jacob Shapiro, M.D., vascular surgeon at TriHealth in Cincinnati, OH.
  • View the full release here: https://www.businesswire.com/news/home/20240307999862/en/
    The real-world study, "Shorter Time to Assessment and Anticoagulation with Decreased Mortality in Patients with Pulmonary Embolism Following Implementation of Artificial Intelligence Software," evaluated the clinical impact of the Viz PE Solution on time to assessment, time to anticoagulation, and patient outcomes at TriHealth.
  • The study found that implementation of the AI-powered solution combined with PERT activation significantly improved time to assessment and time to anticoagulation with a 74% reduction in in-hospital mortality risk.

Inovia Vein Calls for Increased Awareness Around Deep Vein Thrombosis Risks During DVT Awareness Month

Retrieved on: 
Tuesday, March 5, 2024
Health, Consumer, Women, Surgery, Seniors, Other Health, Men, Pulmonary embolism, Pacific Northwest, Education, Tenderness, Obesity, Pain, Deep vein thrombosis, Swelling, Leg, DVT, Pregnancy, Vein, Risk, Patient, Bed rest, Trauma, Cancer, Birth control

With March being nationally recognized as Deep Vein Thrombosis (DVT) Awareness Month , Inovia Vein , a leading provider of world-class vein health services, is calling for enhanced education and awareness about this potentially life-threatening condition.

Key Points: 
  • With March being nationally recognized as Deep Vein Thrombosis (DVT) Awareness Month , Inovia Vein , a leading provider of world-class vein health services, is calling for enhanced education and awareness about this potentially life-threatening condition.
  • Inovia Vein’s vein health experts are stepping up to spread the word about the condition.
  • “That said, at Inovia Vein, we believe every month should be ‘DVT Awareness Month,’ and we are dedicated to educating the communities we serve and beyond about prevention and education.
  • Inovia Vein, the leading provider of vein health services, is dedicated to offering comprehensive and compassionate care to patients with venous disorders.

Mallinckrodt Presents Data on Real-World Outcomes with THERAKOS™ CELLEX™ Photopheresis System Treatment at the 2024 Tandem Meetings

Retrieved on: 
Wednesday, February 21, 2024
Thermal, Bangladesh Technical Education Board, Pulmonary embolism, Hypotension, Mallinckrodt, Anemia, Month, NIH, PUVA, Meta-analysis, Erythroderma, Excipient, Safety, PUVA therapy, Pain, Infection, Quality of life (healthcare), Deep vein thrombosis, Photopheresis, Artifact, FFS, ECP, Risk, OS, Graft-versus-host disease, Society, Extracorporeal, Methoxsalen, Patient, Systematic review, Burns, Transplant, Massachusetts General Hospital, Sunlight, Literature, Clutch (eggs), Environment, Pharmaceutical industry

DUBLIN, Feb. 21, 2024 /PRNewswire/ -- Mallinckrodt plc, a global specialty pharmaceutical company, today announced a poster presentation of findings from a systematic literature review and meta-analysis of the safety, efficacy, and real-world outcomes of extracorporeal photopheresis (ECP) treatment for patients with steroid-refractory chronic graft-versus-host disease (SR-cGvHD).1 An analysis of 47 studies reporting on the THERAKOS™ CELLEX™ Photopheresis System showed that treatment of SR-cGvHD with ECP was associated with improvements in patients' overall survival (OS), failure-free survival (FFS), and overall response rate (ORR).1 The results will be shared in a poster presentation at the 2024 Tandem Meetings, the combined Transplantation & Cellular Therapy Meetings of the American Society of Transplantation and Cellular Therapy (ASTCT) and the Center for International Blood and Marrow Transplant Research (CIBMTR) taking place February 21-24, 2024 in San Antonio, TX.

Key Points: 
  • Skin-specific response at Months 2-3 and at Months 4-6 were 34.86% (95% CI: 13.26-65.21) and 54.22% (95% CI: 35.67-71.67), respectively.
  • Outcomes may be influenced by therapies not evaluated in the study and the clinical/health economics outcomes may not be solely attributable to THERAKOS ECP.
  • THERAKOS™ Photopheresis is contraindicated in:
    THERAKOS™ Photopheresis treatments should always be performed in locations where standard medical emergency equipment is available.
  • Please refer to the THERAKOS™ CELLEX™ Photopheresis System Operator Manual for a complete list of warnings and precautions and adverse events.