cardiac risk News
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Biotricity surpasses 2 billion recorded and analyzed heartbeats for atrial fibrillation (AFib)
Biotricity Inc. (NASDAQ:BTCY) (“Biotricity” or the “Company”), a medical diagnostic and consumer healthcare technology company, today announced a significant milestone of recording and analyzing over 2 billion heartbeats for Atrial Fibrillation (AFib), the most common type of cardiac arrhythmia and a leading cause of stroke. Bioflux®, Biotricity’s ...
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MFDS Greenlights VUNO Med-DeepCARS, AI Medical Device for Cardiac Arrest Prediction
South Korean artificial intelligence (AI) developer, VUNO Inc. announced today that it has received regulatory approval from the Ministry of Food and Drug Safety (MFDS) for its VUNO Med®–DeepCARS™, an AI medical device for cardiac arrest prediction through vital signs. VUNO Med®–DeepCARS™ is a breakthrough AI-driven medical device that analyzes the potential risk ...
By Vuno Inc.
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ACC: iRhythm`s Zio ECG patch catches arrhythmia in older patients, after TAVR implants
More than a decade after first earning the FDA’s sign-off for its Zio ECG patch, iRhythm is still churning out data to prove beyond a shadow of a doubt the heart monitor’s ability to spot atrial fibrillation and other arrhythmias as early as possible. The latest bit of proof came in the form of a trio of studies presented at the American College of Cardiology’s annual scientific ...
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Lungpacer Medical, Inc. Announces FDA Approval of Emergency Use Authorization of the Lungpacer Diaphragm Pacing Therapy System to Help Address COVID-19 Pandemic
Lungpacer Medical, Inc., a medical device company developing an intravenous catheter-based phrenic-nerve-pacing system, announced today that the FDA has approved the Emergency Use Authorization for the use of the Lungpacer Diaphragm Pacing Therapy System (DPTS) to assist in weaning patients determined by their healthcare provider to be at high risk of weaning failure. According to the FDA ...
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Infraredx, a Nipro Company, Announces Enrollment of First Patient in EXPANSE PTCA study.
Infraredx, a Nipro Company, a pioneer in intravascular imaging for mapping coronary artery disease, announced today the enrollment of the first patient in its EXPANSE PTCA study (NCT04985773) at the Cardiology Associates of North Mississippi in Tupelo, Mississippi. The study will be conducted in the United States with the objective to evaluate safety and effectiveness of the Lacrosse NSE ...
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Infraredx, a Nipro Company, Announces FDA Approval of Expanded Label Claim for the Makoto Intravascular Imaging System
Infraredx, a Nipro Company, a pioneer in intravascular imaging for mapping coronary artery disease, announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to expand the indications for use for its Makoto Intravascular Imaging System. The approval is based on the results of the landmark Lipid-Rich Plaque (LRP) Study, which demonstrated the ability of ...
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CVRx Announces First Clinical Procedure with a New Ultrasound-Guided Implant Approach, the Latest Advancement in Barostim™ for the Treatment of Heart Failure Symptoms
MINNEAPOLIS, June 10, 2021 - CVRx©. developer of the world's first FDA-approved neuromodulation device to treat the symptoms of heart failure (HF). announced the completion of the first clinical procedure with the company's new lead implantation approach. The novel ultrasound-guided technique is the latest advancement of CVRx's Barostim™ Baroreflex Activation Therapy (BAT™) to ...
By CVRx
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CytoSorbents Announces Availability of Preliminary Data Abstracts from Two Endocarditis Studies, including the REMOVE study, to be Presented at the EACTS Conference
CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in intensive care and cardiac surgery using blood purification, announced the public availability of preliminary data abstracts from two separate endocarditis studies, including the REMOVE study, to be presented at the upcoming European Association for Cardio-Thoracic Surgery (EACTS) annual meeting ...
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Galapagos announces CHMP adoption of PRAC’s recommendation for Jyseleca® following extensive safety review of all JAK inhibitors
Galapagos NV (Euronext & NASDAQ: GLPG) today announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), has adopted PRAC’s recommendation to add measures to minimise risk of serious side effects with JAK inhibitors for chronic inflammatory disorders. “JAK inhibitors are an important treatment option ...
By Galapagos NV
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Studies suggest Elucid’s AI software helps to objectively quantify key drivers of stroke and heart attack from computed tomography angiography (CTA)
Computed tomography angiography (CTA) has been increasingly used in the diagnosis of vascular disease and its a modality that offers many potential clinical benefits. The question is, how to actualize that benefit and get the most our of the modality. Elucid has developed an artificial intelligence software that might just answer that question. How AI Can Improve CTA Analysis ...
By Elucid
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