The COVID-19 pandemic has gripped the conversation regarding diagnostic and surveillance testing, but stakeholders nonetheless saw fit to populate the docket for the FDA’s proposal to down-classify tests for the human immunodeficiency virus (HIV) to class II. One of the themes of the feedback was that the proposal excludes a few key items, such as quantitative nucleic acid tests and testing for viral load monitoring, leaving the FDA with some difficult decisions to make.
Despite challenges associated with the ongoing COVID-19 pandemic, Abbott Laboratories saw its first-quarter revenue beating expectations, coming in at $7.73 billion vs. an expected $7.44 billion. Cowen’s Josh Jennings highlighted this result, adding in a note that while there are challenges for nondiabetes medical devices and core diagnostics, areas including diabetes, nutrition, the established pharmaceuticals division and COVID-19 testing shined.
Physicians who perform a variety of device implant procedures face a difficult choice in determining whether a patient should be treated. A new article in the Journal of the American College of Cardiology (JACC) recommends that patients who ordinarily would be candidates for surgical aortic valve replacement (SAVR) might instead be referred for the transcatheter alternative.
Abbott Laboratories, of Abbott Park, Ill., reported that its Triclip transcatheter tricuspid valve repair system has received the CE mark. The device is a nonsurgical treatment for people with tricuspid regurgitation (TR), and, according to the company, it is the first minimally invasive, clip-based tricuspid valve repair device to be commercially available. The Triclip is delivered to the heart through the femoral vein in the leg and works by clipping together a portion of the leaflets of the tricuspid valve to reduce the backflow of blood.
Disaster Management Group (DMG), of Indiantown, Fla., has launched a 15-minute screening tool for COVID-19 that can be administered at drive-thru testing sites. The DMGtest, which is being offered under an FDA waiver, first rolled out in Florida and will soon be available in other parts of the U.S.
Abbott Laboratories, of Abbott Park, Ill., is the latest company to receive emergency use authorization (EUA) from the U.S. FDA for a test to detect SARS-CoV-2, the novel coronavirus responsible for the COVID-19 pandemic. The company said it is shipping 150,000 Realtime SARS-CoV-2 tests immediately to existing customers in the U.S., with plans to produce 1 million tests a week by the end of the month.
SAN JOSE, Costa Rica – Two decades ago, the Costa Rican economy was basically an agriculture-based economy. Since then, the tiny Central American country has emerged as the second-largest med-tech exporter in the region as well as an eager partner and supplier of skilled manpower.
The U.S. FDA has finalized two guidances dealing with class II tests that are subject to Medicare regulations, including the so-called dual CLIA waiver guidance. The agency said it will hold an April 14, 2020, webinar to go over both guidances, allocating 90 minutes to deal with questions about the two documents.
NATIONAL HARBOR, Md. – Berlin-based Biotronik SE & Co. reported new data from the BIOFLOW-V trial showing that its Orsiro ultrathin strut drug-eluting stent (DES) continued to outperform Abbott Laboratories’ Xience DES through three years’ follow-up.
NATIONAL HARBOR, Md. – Cardiovalve Ltd., of Or Yehuda, Israel, scored a double hit with the U.S. FDA, winning a breakthrough device designation for its transcatheter tricuspid valve replacement system, as well as approval to conduct an early feasibility study in tricuspid regurgitation (TR).
