Japan’s PMDA asked for further details on a number of elements included in BioCardia’s CardiAMP preclinical and clinical packages in order to gain approval.
News | Heart Failure
BioCardia Shares Update from Japan PMDA Consultation on CardiAMP Autologous Cell Therapy for Ischemic Heart Failure; Foreign Data Expected to be Sufficient for Product Approval

November 30, 2023 — BioCardia, Inc., a developer of cellular and cell-derived therapeutics for the treatment of ...

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Data from all three patients in non-randomized cohort treated with DSR 2.0 indicate safe and effective maintenance of euvolemia without the need for loop diuretics, considerable benefit in cardiorenal status and dramatic improvement in diuretic response and loop diuretic requirements up to 11 weeks post DSR treatment
News | Heart Failure
Sequana Medical Announces Positive Data from Non-randomized Cohort in US Phase 1/2a MOJAVE Study of DSR 2.0 for Treatment of Heart Failure

November 30, 2023 — Sequana Medical NV, a pioneer in the treatment of fluid overload in liver disease, heart failure and ...

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Inari Medical, Inc., a medical device company with a mission to treat and transform the lives of patients suffering from venous and other diseases, today announced the first patient enrollment in the PEERLESS II study
News | Cardiovascular Clinical Studies
Inari Medical Announces First Patient Enrollment in PEERLESS II Randomized Controlled Trial (RCT)

November 29, 2023 — Inari Medical, Inc., a medical device company with a mission to treat and transform the lives of ...

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Foldax, Inc., a leader in the development of innovative, polymer heart valves, today announced completion of enrollment in the Indian clinical trial of the TRIA polymer surgical mitral heart valve.
News | Cardiovascular Clinical Studies
Foldax Completes Enrollment in India Clinical Trial Evaluating TRIA Polymer Surgical Mitral Heart Valve

November 29, 2023 — Foldax, Inc., a leader in the development of innovative, polymer heart valves, today announced ...

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Study to enroll 15 acute stroke patients across three U.S. sites
News | Stents
InspireMD Announces Strategic Agreement with Jacobs Institute to Execute Early Feasibility Study of CGuard EPS for the Treatment of Acute Stroke Patients with Tandem Lesions

November 29, 2023 — InspireMD, Inc., developer of the CGuard Embolic Prevention Stent System (EPS) for the prevention of ...

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Impella Improves Survival and Heart Recovery
News | Cardiovascular Clinical Studies
First Patient Enrolled in Abiomed’s RECOVER IV Randomized Controlled Trial of Impella as a Therapy for AMI Cardiogenic Shock

November 28, 2023 — Abiomed, part of Johnson & Johnson MedTech[1], announces the first patient in the world has been ...

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New research presented at Radiological Society of North America annual meeting confirms ability of ProFound Breast Health Suite to predict a woman’s one to two-year risk for breast cancer
News | Womens Cardiovascular Health
iCAD’s ProFound AI Can Predict 1-2 Year Risk for Breast Cancer and Reveal Insights for Heart Disease

November 28, 2023 — iCAD, Inc., a global medical technology leader in innovative cancer-detection solutions, will ...

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A Prespecified, Exploratory Analysis of Participants Reports Those with Higher Baseline Inflammation More Likely to Experience a Major Cardiovascular Event (MACE), Cardiovascular Death, and All-Cause Mortality Compared to Those with the Lowest Inflammation
News | Cardiovascular Clinical Studies
Esperion Presents CLEAR Outcomes Analysis of Inflammation as Predictor of Cardiovascular Risk at American Heart Association Scientific Sessions 2023

November 27, 2023 — Esperion announced the presentation of results from a pre-specified, exploratory analysis of CLEAR ...

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First Phase 3 study of TNX-103 in PH-HFpEF patients to start in 4Q 2023 (The LEVEL Study)
News | FDA
Tenax Therapeutics Announces FDA Clearance of IND for TNX-103 (oral levosimendan) for the Treatment of Pulmonary Hypertension with Heart Failure with Preserved Ejection Fraction (PH-HFpEF), Initiation of Phase 3 sites expected 2023

November 27, 2023 — Tenax Therapeutics, Inc., a specialty pharmaceutical company focused on identifying, developing and ...

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News | Atrial Fibrillation
Positive Results from ReVeRA Phase 2 Study of Etripamil Nasal Spray in AFib-RVR Presented by Milestone Pharmaceuticals during AHA 2023

November 24, 2023 — During the American Heart Association Scientific Sessions 2023, held recently in Philadephia, PA ...

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A groundbreaking advancement in the treatment of patients with uncontrolled hypertension (HTN) has been achieved with the recent U.S. Food & Drug Administration (FDA) approvals of two renal denervation (RDN) systems
News | Artificial Intelligence
Renal HeartSciences Announces Closing of License Agreements with the Icahn School of Medicine at Mount Sinai to Develop and Commercialize AI Cardiovascular Algorithms

November 22, 2023 — Heart Test Laboratories, Inc. d/b/a HeartSciences, an artificial intelligence (AI)-powered medical ...

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Medinbox Link and Medinbox Air deliver cutting-edge technologies to enhance digital education and remote proctoring and support for cath labs and interventional rooms globally
News | Artificial Intelligence
Medinbox Advances Company Mission to Improve Access to Medical Education and Remote Support Around the World with Debut of New Product Suites for Interventional Ecosystem at TCT

November 22, 2023 — Medinbox, a leading global provider of video integrated collaboration systems for interventional ...

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The first clinical trial to challenge the routine implantation of a defibrillator in myocardial infarction survivors with heart failure has enrolled its first patient.
News | Cardiovascular Clinical Studies
Trial to Prevent Sudden Death After a Heart Attack Enrolls First Patient

November 22, 2023 — The first clinical trial to challenge the routine implantation of a defibrillator in myocardial ...

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News | Pharmaceuticals
BridgeBio Pharma Presents Additional Clinical Outcomes Data from the Phase 3 ATTRibute-CM Study of Acoramidis in Patients with Transthyretin Amyloidosis Cardiomyopathy (ATTR-CM)

November 21, 2023 — BridgeBio Pharma, Inc., a commercial-stage biopharmaceutical company focused on genetic diseases and ...

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New partnership paves the way for early diagnosis and intervention to improve cardiovascular outcomes and quality of life for patients
News | ECG
AccurKardia Delivers its ECG Interpretation Software Within the Lucem Health Reveal Family of Clinical AI Solutions

November 21, 2023 — AccurKardia, an ECG-led diagnostics software company, announced a multi-year agreement with Lucem ...

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