Author: Ken Dropiewski

Kestra Medical Technologies Receives FDA Premarket Approval for ASSURE Wearable Cardioverter Defibrillator (WCD)

KIRKLAND, Wash.–(BUSINESS WIRE)–Kestra™ Medical Technologies, Inc. announced today that the company has received U.S. Food and Drug Administration (FDA) Premarket Approval for the ASSURE® Wearable Cardioverter Defibrillator (WCD) system. The ASSURE WCD system represents the next generation of monitoring and therapy to protect patients at risk of Sudden Cardiac Death (SCD). The […]

Avive Partners with RapidSOS to Create a New Paradigm for Cardiac Arrest Response

NEW YORK, Aug. 3, 2021 /PRNewswire/ — Avive Solutions, Inc, a company bringing to market a revolutionary connected Automated External Defibrillator (AED) coupled with a first of its kind out-of-hospital cardiac arrest (OHCA) response platform, today announced a partnership with RapidSOS. Together, the solutions are designed to quickly get life-saving AEDs to cardiac […]

CINDE announces: Baylis Medical Opens MedTech Facility in Costa Rica

Headquartered in Canada, the company will manufacture in Costa Rica cardiovascular products to serve global markets. The 2.800 mts2 facility will be in La Lima Free Zone. CARTAGO, Costa Rica, Aug. 3, 2021  /PRNewswire/ — Baylis Medical, a Canadian company and leader in the development and commercialization of innovative medical devices in cardiology, announced today its […]

Lumosa Therapeutics Announces Positive Results from LT3001 Phase 2a Clinical Trial in Acute Ischemic Stroke

LT3001 met primary safety endpoint. No symptomatic intracranial hemorrhage occurred. LT3001 showed pronounced neurological improvement in the majority of patients with baseline NIHSS ≥6 treated with LT3001. These data suggest that LT3001 has the potential to provide significant clinical benefit to patients up to 24 hours after the onset of […]

ESPERION Reports Second Quarter 2021 Financial Results and Provides Company Update

– U.S. Net Product Revenue of NEXLETOL® (bempedoic acid) Tablets and NEXLIZET® (bempedoic acid and ezetimibe) Tablets Grew 67% Sequentially to $10.6 Million – – Growth Driven by Increase in Demand and Substantial Improvement in Net Price – – Prescriptions Grew 28% During the Quarter; More Than 47,800 Patients Have Filled a Prescription for […]

ABBOTT INTRODUCES JOT DX™ INSERTABLE CARDIAC MONITOR, DESIGNED TO REDUCE DATA BURDEN AND IMPROVE ACCURATE DIAGNOSIS OF DIFFICULT-TO-DETECT ABNORMAL HEART RHYTHMS

– Jot Dx™ Insertable Cardiac Monitor (ICM) expands Abbott’s connected care portfolio and is the first and only device on the market with the option to control the amount of electronic data received for irregular heart rhythms, depending on the unique needs of the patient or clinic – Jot Dx™ […]

Orchestra BioMed™ Announces Clinical Data Demonstrating a Significant and Sustained Reduction in Blood Pressure in MODERATO II Control Patients After Crossover to BackBeat Cardiac Neuromodulation Therapy™

Clinically meaningful and statistically significant reduction in systolic blood pressure is consistent with the decrease previously observed in the study treatment group during the same time period. Ambulatory Systolic Blood Pressure (aSBP) decreased by an average of 10.3 mmHg (p<0.01) at 6 months. Office Systolic Blood Pressure (oSBP) decreased by an average […]