medical device guru

Cardiovascular / Cardiology
VivaLNK Announces World’s First FDA Cleared Wearable ECG Sensor Platform
VivaLNK, a leading provider of connected healthcare solutions, today announces it received FDA clearance for its Continuous ECG Platform. Consisting of reusable wearable ECG sensors and associated software development kit (SDK), the sensor platform gives developers and providers direct control...
January 23, 2020
Cardiovascular / Cardiology
BioCardia Announces FDA Clearance for Morph DNA Catheter to Guide Cell Delivery into Heart Tissue
BioCardia (BCDA)®, Inc. , a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today announced the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the Morph® DNA deflectable guide catheter used to guide the Helix™...
January 20, 2020
Cardiovascular / Cardiology
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...
January 9, 2020
Cardiovascular / Cardiology
FDA Grants Breakthrough Device Designation to Reflow Medical’s Temporary Spur Stent System 
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)....
January 9, 2020
Cardiovascular / Cardiology
ZipThaw, the World’s First Portable, Precise Plasma Thawing Medical Device, Receives FDA Clearance for Clinical Use
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...
January 6, 2020
Cardiovascular / Cardiology
Masimo Announces FDA Clearance for Neonatal RD SET Pulse Oximetry Sensors with Improved Accuracy Specifications 
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,...
December 30, 2019
Cardiovascular / Cardiology
Clinical Study Utilizes the myTAIHEART Test to Monitor Cell-Free DNA Levels, 2-10 Days Post-Transplantation, in Pediatric Heart Transplant Recipients 
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...
December 18, 2019
Cardiovascular / Cardiology
First Patient Enrolls in New Trial for Abiomed’s Impella Looks for Heart Failure Reduction
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...
December 16, 2019
Cardiovascular / Cardiology
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...
December 5, 2019
1 2 3 18