November 2, 2021 — Datascope/Getinge/Maquet is recalling its Cardiosave Hybrid/Rescue Intra-Aortic Balloon Pumps (IABP) because of reports the battery packs can fail. The U.S. Food and Drug Administration sent out a notice this week that this is a Class I Recall because of the risk of serious injury or death.

November 1, 2021 — According to ARRS’ American Journal of Roentgenology (AJR), radiologists need to be cognizant of the association between coronavirus disease (COVID-19) mRNA vaccination and myocarditis, as well as the role of

The FDA cleared the world's first photon-counting computed tomography (CT) scanner, the Siemens Naeotom Alpha, in late September. This new technology will likely change the future direction of CT. Biosense Webster also announced the first cases using its Heliostar radiofrequency balloon ablation catheter were completed in September. Both were among the top stories in October.

November 1, 2021 — Here is the list of the most popular content on the Diagnostic and Interventional Cardiology (DAIC) magazine website from the month of October 2021. This is based on the website’s 182,336 pageviews for the month.

1. First Photon-counting CT System Cleared by the FDA

2. First Woman in World Receives New Type of Artificial Heart

November 1, 2021 — Health AI company Vagus.co, based in Cambridge, U.K., has launched a 30-second breathing test for Apple Watch. The wearable device technology enables users to see how they breath. The vendor is promoting the product to help with relieving stress through controlled breathing, but the technology may have applications for clinical monitoring. The vendor is looking at using it to monitor long-COVID patients.

Cardiac CT Given Strong Recommendation as Front-line Imaging of Chest Pain, but the American Society of Nuclear Cardiology (ASNC) did not support the guidelines.

October 29, 2021 — A new guideline for the evaluation and diagnosis of chest pain was released this week that provides recommendations and algorithms for clinicians to assess and diagnose chest pain in adult patients.[1]  It is a multi-society guideline and represents the first-ever U.S. or international guideline for the evaluation and diagnosis of patients with acute or stable chest pain.
Implicity provides a remote cardiac monitoring and research platform used by Independent Diagnostic Testing Facilities and medical centers to deliver high-quality care for patients with connected cardiac devices. On this platform, Implicity aggregates, normalizes and standardizes data from any implantable cardiac device across all manufacturers.

With 1.2 to 1.4 million new electrophysiology (EP) devices being prescribed to patients around the world each year, cardiac implantable electronic devices (CIEDs) remote monitoring has become the standard of care for those living with a variety of cardiac health conditions.[1] Using data collected by the devices, physicians can help improve both patient survival rates and their quality of life.

October 28, 2021 – The first patient has been treated in a new trial using stem cell therapy to treat chronic myocardial ischemia with refractory angina. BioCardia Inc., a company focused on developing cellular and cell derived therapeutics for the treatment of cardiovascular and pulmonary diseases, announced the treatment of the first patient in its Phase III pivotal CardiAMP Cell Therapy Chronic Myocardial Ischemia Trial for patients with no other options.

October 28, 2021 — CathVision, a medical technology company developing electrophysiology (EP) solutions in EP recording technology, said the first patient enrollments in the PVISION multicenter clinical study. 

Cardiovascular Ultrasound Analytics Aids Re-accreditation Process 

Accurate reporting is essential to producing the reliable analytics needed to meet lab accreditation standards. This is a process Susan Wayne, RRT, RVT, RCDS, is quite familiar with.

October 27, 2021 — Impulse Dynamics announced the U.S. Food and Drug Administration approved a modification of labeling for the Optimizer Smart medical device, allowing the removal of “normal sinus rhythm” (NSR) from the indications for use statement. Since heart failure patients are no longer required to be in NSR at the time of Optimizer implant, heart rhythm does not impose any restrictions on patients eligible for Optimizer implant, thereby vastly increasing the number of patients who can be treated with CCM therapy.

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