Colospan Wins IDE FDA Approval for Intraluminal Bypass Device

Colospan which develops novel solutions for colorectal surgery, announced today that the United States Food and Drug Administration (FDA) has approved the company’s investigational device exemption (IDE) application. With this IDE approval in hand, the company will launch its pivotal study for CG-100, a temporary Intraluminal Bypass Device, designed to reduce diverting stoma rates in patients…

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FDA Grants Breakthrough Device Designation to Reflow Medical’s Temporary Spur Stent System 

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Reflow Medical announces that the Temporary Spur Stent System, a novel retrievable stent technology intended for the treatment of below-the-knee (BTK) peripheral artery disease, has been designated for the Breakthrough Devices Program by the U.S. Food and Drug Administration (FDA). The Breakthrough Devices Program is designed to give patients and health care providers timely access…

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ZipThaw, the World’s First Portable, Precise Plasma Thawing Medical Device, Receives FDA Clearance for Clinical Use

FreMon Scientific ZipThaw

FreMon Scientific is pleased to announce the FDA has now cleared ZipThaw™ for frozen plasma thawing as a Class II medical device. ZipThaw, used with the ZipSleeve™ anti-contaminant disposable barrier, is the world’s first dry and portable precision plasma thawing system. Clinicians can now deliver vital plasma to patients at the right time and temperature.…

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Masimo Announces FDA Clearance for Neonatal RD SET Pulse Oximetry Sensors with Improved Accuracy Specifications 

Baby RD Neo_Final

Masimo announced today that RD SET® sensors with Masimo Measure-through Motion and Low Perfusion™ SET® pulse oximetry have received FDA clearance for improved oxygen saturation (SpO2) accuracy specifications for neonatal patients (< 3 kg). The updated RD SET® sensors’ SpO2 accuracy specifications have improved significantly, from 3% to 1.5% ARMS1 (at 1 standard deviation), in conditions of motion and no motion,…

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Clinical Study Utilizes the myTAIHEART Test to Monitor Cell-Free DNA Levels, 2-10 Days Post-Transplantation, in Pediatric Heart Transplant Recipients 

Tai Diagnostics Logo

TAI Diagnostics, Inc., focused on developing innovative diagnostic tests for monitoring the health of transplanted organs, today announced the publication of “Early Changes in Cell-Free DNA Levels in Newly Transplanted Heart Transplant Patients” in the December 11th open access version of Pediatric Transplantation, the official journal of the International Pediatric Transplant Society. The publication provides results from a prospective…

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First Patient Enrolls in New Trial for Abiomed’s Impella Looks for Heart Failure Reduction

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Abiomed (NASDAQ: ABMD) announces initiation of the ST-Elevation Myocardial Infarction Door-to-Unloading (STEMI DTU) Pivotal Randomized Controlled Trial (RCT), which will explore whether unloading the heart’s left ventricle for 30 minutes with an Impella heart pump prior to opening blocked arteries will reduce infarct size after a heart attack and lead to a reduction in future heart failure rates.…

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Doctors ‘reanimate’ heart for first-of-its-kind transplant in the US

TransMedics announced today that the doctors at two hospitals performed the first U.S. heart transplants using donor hearts that were resuscitated using the company’s organ care system (OCS). The transplants from donation after circulatory death (DCD) took place at Duke University Hospital in Durham, N.C. and Massachusetts General Hospital in Boston. In a DCD procedure, the…

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ALung Technologies Announces Continued Progress Towards Completion of Two Landmark Pivotal Trials 

ALung Machiene

ALung Technologies, Inc., the leading provider of low-flow extracorporeal carbon dioxide removal (ECCO2R) technologies for treating patients with acute respiratory failure, announced the recent achievement of two significant clinical trial milestones, enrollment of 60 plus patients in its U.S. based VENT-AVOID clinical trial and greater than 400 patients in the UK-REST clinical trial. COPD affects 30…

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BioVentrix Gains FDA Breakthrough Device Designation for their Revivent TC Transcatheter Ventricular Enhancement System

Bioventrix Logo

BioVentrix, Inc., a privately-held company with a first-in-class, transcatheter-based structural heart device to treat heart failure, today announced that the U.S. Food and Drug Administration (FDA) has granted the company Breakthrough Device Designation status for its Revivent TC™ Transcatheter Ventricular Enhancement System for heart failure. Less Invasive Ventricular Enhancement, or the LIVE™ procedure, uses the…

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Centerline Biomedical Announces First-in-Human Use of IOPS™ Intra-Operative Positioning System

Centerline Biomedical

Centerline Biomedical, Inc., a spinout company from Cleveland Clinic, announced the successful first human clinical use of its groundbreaking IOPS™ technology. IOPS, the Intra-Operative Positioning System, provides doctors performing minimally-invasive vascular repairs with an intuitive, interactive color 3D display. IOPS, the Intra-Operative Positioning System, provides doctors performing minimally-invasive vascular repairs with an intuitive, interactive color 3D…

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