Katherine Fornell, age 5, from suburban Chicago, receives her first dose of the COVID-19 vaccine during the first week it became available in the U.S. The FDA authorized the emergency use of the Pfizer-BioNTech COVID-19 vaccine Oct. 29 for the prevention of COVID-19 in children 5 to 11 years of age. This was based on a safety review of more than 3,000 patients receiving the vaccine ages 5-11.

November 5, 2021 — The U.S. Food and Drug Administration (FDA) authorized the emergency use of the Pfizer-BioNTech COVID-19 vaccine Oct. 29 for the prevention of COVID-19 in children 5 to 11 years of age. 

The emergency use authorization (EUA) was based on the FDA’s evaluation of the data that included input from independent advisory committee experts who overwhelmingly voted in favor of making the vaccine available to children in this age group.
American Society of Nuclear Cardiology (ASNC) President Randy Thompson, M.D., getting his COVID-19 vaccine when the vaccines first became available last December. Nearly a year later, some healthcare workers are still holding out and refuse to get the vaccine, which prompted CMS (Medicare) to now require COVID vaccinations for all healthcare workers at facilities that accept Medicare and Medicaid patients.

November 4, 2021 — The Centers for Medicare and Medicaid Services (CMS) today issued an emergency regulation now requiring COVID-19 vaccinations for all eligible staff at healthcare facilities that participate in the Medicare and Medicaid programs. 

CMS has set a deadline of Dec. 5 for healthcare facilities to create a COVID vaccination requirement policy and  a deadline of Jan. 4, 2022 for all staff at these facilities to be fully vaccinated.

November 2, 2021 — Cardionomic Inc. announce initial U.S. enrollment in its global Cardiac Pulmonary Nerve Stimulation (CPNS) Pilot Study (NCT04814134). The study is evaluating the safety and performance of the CPNS System in patients suffering from acute decompensated heart failure (ADHF), defined as new or worsening symptoms of heart failure. 

 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.

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