While the FDA said the risk that SARS-CoV-2 virus mutations will only have a minor impact on testing accuracy is low, the agency singled out three tests are they had a higher concern. FDA warns PCR tests may be innaccurate with new UK virus varient.

January 8, 2021 — The U.S. Food and Drug Administration (FDA) is alerting healthcare providers that it is monitoring the potential impact of COVID (SARS-CoV-2) viral mutations, including the emerging variant from the United Kingdom and its potential to produce false negative results on FDA authorized SARS-CoV-2 molecular tests.

Despite the alert issued today, the FDA believes the risk that these mutations will impact overall testing accuracy is low.

January 8, 2021 — The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the Inari Medical Inc. FlowTriever system for the treatment of clot in transit (CIT) in the right atrium.

FlowTriever is the first thrombectomy system not requiring a cardiopulmonary bypass circuit to be FDA cleared for blood clots in the right atrium. 

January 8, 2020 – RSIP Vision has launched a new artificial intelligence (AI) ultrasound module that enables fast and accurate point-of-care heart evaluations. This includes onsite diagnostic from the parasternal long axis (PLAX) view. This new vendor-neutral technology will be available to third-party ultrasound manufacturers and medical devices vendors.

January 6, 2020 — A new Weill Cornell Medicine found the risk of dying seven years after coronary artery bypass graft (CABG) surgery was significantly lower in men receiving multiple bypass grafts rather than single grafts. The study also looked at CABG in women and there was no apparent difference between single or multiple vessel bypass procedures, but overall women had a higher mortality rate. The study published online Dec.

January 6, 2021 — Smoking traditional cigarettes in addition to using e-cigarettes results in harmful health effects similar to smoking cigarettes exclusively, according to new research published today in the American Heart Association (AHA) flagship journal Circulation.[1]

January 6, 2021 — The U.S. Food and Drug Administration (FDA) has granted the designation of breakthrough device to P+F Products + Features GmbH TricValve Transcatheter Bicval Valves System.  

January 6, 2021 — The U.S. Food and Drug Administration (FDA) has cleared Ultromics' EchoGo Pro, an artificial intelligence (AI) powered, outcomes-driven, decision support tool to automatically identify coronary artery disease (CAD) in echocardiograms. 

Houston Aortic Symposium: Frontiers in Cardiovascular Diseases

The most popular DAIC content in December 2020 included the Boston Scientific Lotus TAVR valve being taken off the market, CMS approving expanding coverage of LVADs for more Medicare patients and numerous COVID-19 related cardiology stories and videos.

January 5, 2021 — Here is the list of the most popular content on the Diagnostic and Interventional Cardiology (DAIC) magazine website from the month of December 2020. This is based on the website’s record 550,357 pageviews for the month. 

1. Image Gallery Showing Impact of the COVID-19 Pandemic

There was much fanfare over the U.S. Food and Drug Administration (FDA) emergency use authorizations (EUAs) in December for the Pfizer and Moderna COVID-19 (SARS-CoV-2) vaccines. However, the vaccination program to date has fallen very far short the promises made by the government when the first vaccine was approved, with less than one quarter of the promised vaccine being delivered.

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