News

2013 Ultrasound Market Report Klein Biomedical Consultants Inc.

According to The Medical Diagnostic Ultrasound Market in the USA: Challenges & Opportunities in the New Millennium, 2013 report, the U.S. ultrasound market grew almost 3 percent last year...

CardioMEMS Heart Failure System FDA Approval

The U.S. Food and Drug Administration (FDA) granted market clearance to the CardioMEMS Heart Failure System, the first FDA-approved heart failure (HF) monitoring device shown in clinical trials to...

Boston Scientific REPRISE II Clinical Trial Six-month Results Lotus Valve

Further validating its advanced transcatheter aortic valve implantation (TAVI) technology, the Boston Scientific Corp. Lotus Valve System continued to demonstrate impressive performance at six...

As a cardiovascular technology magazine editor, I keep tabs on what technology is in development and often have the opportunity to see the most cutting edge technology up close prior to U.S. Food...

Direct Flow Medical Transcatheter Aortic Valve 12-month Outcomes

Direct Flow Medical Inc. announced 12-month outcomes from the DISCOVER CE mark clinical trial.

May 27, 2014 — Ekos Corp. announced the U.S. Food and Drug Administration (FDA) has cleared the EkoSonic endovascular system for the ultrasound-facilitated, controlled and selective infusion...

Terumo BCT has entered into a business relationship with Kaneka to gain market authorization in the United States for the use of the Terumo BCT Spectra Optia Apheresis System with the Kaneka...

May 23, 2014 — Stentys presented final results from the APPOSITION IV study of its new self-apposing sirolimus-eluting stent (SES) during the Hotline session at the EuroPCR conference in Paris.

May 23, 2014 — The first drug-eluting balloon to go up for review by the U.S. Food and Drug Administration (FDA) will be discussed at the next Circulatory System Devices Panel of the Medical...

Journal of Endovascular Therapy Hypertension Renal Denervation Therapy

Patients with hypertension after renal artery stenting who do not respond to drug treatment may have another option. 

3-d pronting, 3D printing

The FDA has recognized 3-D printing technology now exists to print medical devices and is gathering information regarding technical assessments that should be considered when it will inevitably...

St. Jude Medical Portico TAVR System U.S. Implants Clinical Study

St. Jude Medical Inc. announced that the first patient implants occurred in the Portico Re-sheathable Transcatheter Aortic Valve System U.S. IDE Trial (PORTICO trial).

Transcatheter Technologies Gmbh Trinity TAVI Heart Valve Repair EuroPCR 2014

Transcatheter Technologies GmbH, an emerging medical device company that is developing a third-generation transcatheter aortic valve implantation (TAVI) system — Trinity) — announced that its...

Corevalve, FDA, Edwards, TAVR, TAVI, lawsuit, injunction

In a surprise move, Edwards Lifesciences Corp. and Medtronic reached an agreement this week to settle all outstanding patent litigation between the companies, including cases related to...

cardiology Inventory management

Computerized and semi-automated inventory control system technology offers a more efficient way for cardiovascular departments, especially catheterization and electrophysiology (EP) labs, to track...

For the first time, a minimally invasive transcatheter valve — tested by Baylor Research Institute in Dallas (BRI) — has been shown to save more lives than open-heart surgery, according to new...

Advanced Circulatory, makers of medical devices providing Intrathoracic Pressure Regulation (IPR) Therapy, will continue to work with the U.S. Food and Drug Administration (FDA) on a pathway to...

May 16, 2014 — In a move to expand significantly its portfolio of solutions for peripheral interventions, Boston Scientific Corp. has entered into a definitive agreement to acquire the...

CathMaps+ App Cath Lab Patient Engagement Mobile Devices

CathMaps demonstrated how mobile technology can provide emergency assistance and peace of mind to millions of Americans at risk for a cardiac event. 

OrbusNeich announced the launch of the Sapphire II NC coronary dilatation catheter, a non-compliant balloon catheter engineered to cross tight lesions, outside the United States.