medical device guru

Cardiovascular / Cardiology

Aria CV Receives FDA Breakthrough Designation for Its Medical Device for Treating Pulmonary Arterial Hypertension 

Aria CV, Inc., a developer of medical devices treating Pulmonary Arterial Hypertension (PAH), today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the Aria CV Pulmonary Hypertension System (Aria CV PH System). The...

February 6, 2020

Cardiovascular / Cardiology

Imricor’s MRI-Compatible Ablation Catheters Cleared in Europe for Cardiac Arrhythmia Treatment

Imricor Medical Systems, Inc. (ASX:IMR) today announces that it has received CE mark approval for its Vision-MR Ablation Catheter and Vision-MR Dispersive Electrode. This follows earlier CE mark approval for Imricor to place its Advantage-MR EP Recorder/Stimulator System on the market...

January 30, 2020

Cardiovascular / Cardiology

FDA Clears Eko’s AFib and Heart Murmur Detection Algorithms, Making It the First AI-Powered Stethoscope to Screen for Serious Heart Conditions

Eko, a digital health company applying artificial intelligence (AI) in the fight against heart disease, announced today that the U.S. Food and Drug Administration has cleared a suite of algorithms that, when combined with Eko’s digital stethoscopes, will enable healthcare...

January 29, 2020

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