The U.S. Food and Drug Administration (FDA) sent a letter to cardiologists this week to explain its evaluation of high mortality rates reported in the Abiomed Impella RP heart pump post-approval study (PAS). The FDA believes the mortality rate might be higher than the pre-market study because of inappropriately selected patients receiving the device.


In 2018, capital investment in companies developing artificial intelligence (AI)-enabled medical image analysis solutions was almost $580 million. This was more than double the investment into such companies in 2017, according to market research firm Signify Research.

Canon Medical Systems USA recently introduced its next generation of interventional systems – the Alphenix platform. The new flagship platform of systems incorporates all-new features that enable clinicians to deliver images with clarity and precision without compromising workflow and while prioritizing low dose.

Biosense Webster has enrolled and treated the first patient in its U.S. Investigational Device Exemption (IDE) study evaluating the company’s QDot Micro radiofrequency (RF) ablation catheter in the treatment of symptomatic drug-refractory paroxysmal atrial fibrillation (AF). The first AF patient was treated at NYU Langone Health’s Heart Rhythm Center in New York City, one of up to 30 centers participating in the study that will enroll up to 185 patients throughout the U.S.


February 4, 2019 — Stryker announced Feb. 1, the company is launching a voluntary field action on specific units of the LifePak 15 Monitor/Defibrillators. The company is notifying certain customers of an issue that may cause the device to lock up after a defibrillation shock is delivered. 


Paragonix Technologies Inc. recently received clearance from the U.S. Food and Drug Administration (FDA) for a design enhancement allowing for the use of the Paragonix SherpaPak Cardiac Transport System (CTS) with small and pediatric donor hearts. Starting in Q1 2019, the system will now be shipped with heart connectors covering most aortic diameters, permitting the anchoring of various size hearts including small pediatric hearts to its proprietary suspension system for improved donor heart transport.

A team of Rutgers scientists have taken an important step toward the goal of making diseased hearts heal themselves – a new model that would reduce the need for bypass surgery, heart transplants or artificial pumping devices.

Subscribe Now