Cardiovascular

Aria CV Wants to Offer a Device Option for Pulmonary Arterial Hypertension

The St. Paul, MN-based company raised $31 million in a series B round to fund the early feasibility study of its Aria CV Pulmonary Hypertension System. The device is entering a space that is dominated by pharmaceutical offerings.

J&J and Apple Begin Enrollment for Heartline Study

The study is designed to explore if the Heartline Study app on iPhone and heart health features on Apple Watch can improve health outcomes, including reducing the risk of stroke, with earlier detection of atrial fibrillation.

Cardiovalve Reaches 2 Milestones for its Tricuspid Valve Replacement System

The Or Yehuda, Israel-based company was able to obtain Breakthrough Device Designation and FDA approval of a feasibility study for its transcatheter tricuspid valve replacement system.

Abbott’s Coronary Dilation Catheters Face Class I Recall

The recall surrounds specific lots of the NC Trek RX Coronary Dilatation Catheter with diameters of 4 mm, 4.5 mm, and 5mm.

Abbott Picks Up Key Approval for ICD Technology

The Abbott Park, IL-based company has won CE mark for the Gallant ICD and CRT-D devices.

Paclitaxel Controversy Is Causing CE Mark Delays for New Paclitaxel Devices

The fate of Surmodics' SurVeil CE mark submission is unclear as the European notified body has temporarily halted review of new paclitaxel devices.

BioVentrix Scores ‘High Priority’ Reimbursement in Germany

The San Ramon, CA-based company has developed the Revivent TC TransCatheter Ventricular Enhancement System, a technology for left ventricular remodeling after a heart attack.

Abbott Continues to Show Heart with ‘Breakthrough’ Announcement

The company has received Breakthrough Device Designation from FDA for the Fully Implantable Left Ventricular Assist System (FILVAS).

Abbott Wins Approval for CATALYST Trial for At-Risk Stroke Patients

Abbott Laboratories started off 2020 strong in the cardiovascular space. First the company announced receiving CE mark approval for the Tendyne transcatheter mitral valve implantation system along with winning approval for the CATALYST trial.

Abbott Has Big Win in TMVI Market

The Abbott Park, IL-based company has won CE mark for the Tendyne Transcatheter Mitral Valve Implantation (TMVI) system. Abbott inherited the TMVI system when it acquired Tendyne Holdings for $225 million in 2015.

Eko’s New Algorithm Helps Digital Stethoscope Give Insight on Heart Conditions

The San Francisco, CA-based company won clearance for atrial fibrillation and heart murmur detection algorithms.

BioCardia Fills in a Key Piece of CardiAmp Puzzle with New Clearance

The San Carlos, CA-based company has received a nod from FDA for the Morph DNA deflectable guide catheter, which is used to guide the Helix Biotherapeutic Delivery System during CardiAMP cell therapy delivery in the heart.

Does JenaValve’s New Designation Signal the Start of Another Strong Year for TAVR?

2019 was a busy year for the transcatheter aortic valve replacement market. JenaValve’s Breakthrough Device Designation from FDA builds on that momentum and could help make 2020 a stellar year for TAVR.

Abbott's New Designation Helps Advance its Position in LVAD Market

The Abbott Park, IL-based company has won a nod from FDA for a less invasive surgical approach for the HeartMate 3 Left Ventricular Assist Device. The firm’s rival, Dublin-based Medtronic won the same designation for the HVAD in 2018.

AtriCure Completes Patient Enrollment for aMAZE Trial

The Mason, OH-based company inherited Lariat, the device being evaluated in the aMAZE clinical trial, when it acquired SentreHeart for $300 million last year.

Using Imaging for Early Intervention After a Heart Attack

A new study shows that a radiotracer can effectively image fibroblast activation after a heart attack. This could lead to improved outcomes for heart attack patients.

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