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Cardiovascular / Cardiology

Siemens Healthineers Completes  Corindus Vascular Robotics Acquisition for $1.1B

Siemens Healthineers AG completed the acquisition of 100 percent of Corindus Vascular Robotics, Inc. effective October 29, 2019. Prior to the closing of the acquisition, Corindus held a shareholders’ meeting on October 25, 2019, at which 87.5 percent of their...

October 29, 2019

Cardiovascular / Cardiology

3D Printed Cells and Bioinks for Making Implantable Blood Vessels

A biomimetic blood vessel was fabricated using a modified 3D cell printing technique and bioinks, which were formulated from smooth muscle cells from a human aorta and endothelial cells from an umbilical vein. The result is a fully functional blood...

October 28, 2019

Cardiovascular / Cardiology

CorFlow Therapeutics Gains “Breakthrough Device Designation” for CoFI™ (COF-fee) System

CorFlow Therapeutics AG announced that the FDA has designated the company’s CoFI (CorFlow Controlled Flow Infusion) System as a “Breakthrough Device” with a broad indication-for-use statement: “The CoFI™System is indicated for diagnostic assessment of the coronary microcirculation immediately following PCI (“stenting”), and to be a...

October 23, 2019

Cardiovascular / Cardiology

FDA Clears geko Muscle Pump Activator to Prevent VTE

Sky Medical Technology Ltd, has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its geko™ device for stimulation of the calf muscles to prevent venous thrombosis in non-surgical patients at risk for venous thromboembolism (VTE). This adds to Sky’s...

October 16, 2019

Cardiovascular / Cardiology

AngioDynamics Acquires Eximo Medical, Ltd. and its Innovative 355nm Laser Atherectomy Technology 

AngioDynamics, Inc., a leading provider of innovative, minimally invasive medical devices for vascular access, peripheral vascular disease, and oncology, today announced that it has acquired Eximo Medical, Ltd., an early commercial stage, medical device company, and its proprietary 355nm wavelength...

October 9, 2019

Cardiovascular / Cardiology

Medtronic Receives FDA Breakthrough Device Designation for Developing Stent Graft System to Treat Thoracoabdominal Aortic Aneurysm 

Medtronic today announced it has received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for its Valiant® TAAA Stent Graft System for minimally invasive repair of thoracoabdominal aortic aneurysm (TAAA). A TAAA is a complex condition causing...

October 9, 2019

Cardiovascular / Cardiology

Cardiovascular Systems, Inc. Announces FDA Approval of the Coronary ViperWire Advance® With Flex Tip 

Cardiovascular Systems, Inc. (CSI) (NASDAQ: CSII), a medical device company developing and commercializing innovative interventional treatment systems for patients with peripheral and coronary artery disease, today announced U.S. Food and Drug Administration (FDA) PMA approval of the new ViperWire Advance® Coronary...

September 24, 2019

Cardiovascular / Cardiology

BIOLIFE4D Bioprints Small Human Heart for the First Time in the U.S.

BIOLIFE4D, one of the pioneers in the bioprinting field, has been able to bioprint a miniature human heart – making it the first U.S. company to successfully achieve this. The company’s mission is to create a fully functioning human heart through...

September 23, 2019

Cardiovascular / Cardiology

Biotronik First to Land MDR Certification for a High-Risk Device

Biotronik said that it is the first medtech manufacturer to receive European Medical Device Regulation (MDR) certification for a Class III (highest risk) medical device. The newly certified device is Biotronik’s Renamic programmer software, which enables physicians to program and test...

September 19, 2019