iRhythm Technologies (NSDQ:IRTC) today touted study results that found its Zio device was more effective in detecting Afib than standard care. Published in JAMA Cardiology, the SCREEN-AF study showed that the use of Zio by iRhythm led to a tenfold increase in the detection of Afib when compared to patients receiving standard clinical care. One of […]
Clinical Trials
FDA analysis finds J&J’s single-done COVID-19 vaccine is safe, effective
An FDA analysis found that the single-dose COVID-19 vaccine candidate developed by Johnson & Johnson (NYSE:JNJ) is safe and effective. The analysis comes two days ahead of the FDA’s meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Feb. 26, 2021, to discuss the EUA request for the vaccine. Johnson & Johnson submitted the EUA […]
J&J submits EUL application to WHO for single-shot COVID-19 vaccine
Johnson & Johnson (NYSE:JNJ) announced today that it submitted for emergency use listing (EUL) to the World Health Organization (WHO) for its COVID-19 vaccine. New Brunswick, N.J.-based J&J’s Janssen subsidiary’s single-dose COVID-19 vaccine candidate was submitted for EUL with a data package including interim efficacy and safety results from the Phase 3 Ensemble clinical trial, which […]
Pfizer, BioNTech start trial to evaluate COVID-19 vaccine’s effect on pregnant women
Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) announced today that it dosed the first participants in a trial of its COVID-19 vaccine for pregnant women. The companies, which developed one of the two COVID-19 vaccines to be authorized in the U.S. so far, are conducting a global Phase 2/3 study to evaluate the safety, tolerability and immunogenicity of the vaccine […]
Medtronic issues voluntary recall of Valiant Navion thoracic stent graft system
Medtronic (NYSE:MDT) announced today that it issued a voluntary recall of unused Valiant Navion thoracic stent graft systems. Fridley, Minn.-based Medtronic’s global recall included informing physicians to immediately cease use of the device until further notice, according to a news release. The company initiated the recall in response to information it recently obtained from the Valiant […]
Hancock Jaffe completes $41M offering
Hancock Jaffe Laboratories (NSDQ:HJLI) announced that it successfully completed a public offering worth $41.1 million. Irvine, Calif.-based Hancock Jaffe sold more than 5.9 million shares of common stock and warrants to purchase nearly 3 million common shares in the offering, according to a news release. The $41.1 million collected in proceeds by the company are earmarked […]
Medtronic touts newborns study involving its Nellcor pulse oximetry tech
Medtronic (NYSE:MDT) announced today that study results showed superiority for its Nellcor pulse oximeter against technology from Masimo (NSDQ:MASI). Fridley, Minn.-based Medtronic’s Nellcor bedside SpO2 patient monitoring system was compared with the Masimo Radical-7 pulse co-oximeter with both set at the highest sensitivity for electrocardiography (ECG) monitoring following the delivery of 60 term newborns by Caesarian section, according […]
Johnson & Johnson applies for vaccine approval from FDA
Johnson & Johnson (NYSE:JNJ) announced that it submitted an FDA emergency use authorization (EUA) application for its COVID-19 vaccine candidate. New Brunswick, N.J.-based J&J’s Janssen Biotech subsidiary submitted the application for its investigational single-dose Janssen COVID-19 vaccine candidate, based on safety and efficacy data from its Phase 3 Ensemble clinical trial that met all of its […]
MIT researchers tout origami-inspired medical patch for internal injuries
Engineers at MIT are touting a medical patch capable of being delivered through narrow spaces to patch up internal injuries. With inspiration from the art of origami, the engineers designed the patch to be folded around minimally invasive surgical tools and delivered through airways, intestines and other narrow spaces to patch up internal injuries, according […]
Abiomed touts results of Impella study
Abiomed (NSDQ:ABMD) recently announced positive results from a study of its Impella 5.5 heart pump with SmartAssist. Danvers, Mass.-based Abiomed’s study across 16 U.S. and German locations found a 79% survival rate at explant in 356 patients treated with Impella 5.5 with SmartAssist. A majority of surviving patients recovered native heart function without needing further mechanical […]
Edwards touts 5-year aortic valve trial results
Edwards Lifesciences (NYSE:EW) announced data showing favorable safety and hemodynamic performance from its Resilia tissue platform. Data from Edwards’ Commence clinical trial demonstrated that its bioprosthetic surgical aortic valve with the novel Resilia tissue aortic valve platform produced favorable results across a median of five years follow-up, according to a news release. Commence is a prospective, […]
