Author: Ken Dropiewski

FDA Grants First-Ever Clearances to Detect Bradycardia and Tachycardia on a Personal ECG Device

MOUNTAIN VIEW, Calif., April 23, 2019 /PRNewswire/ — AliveCor, the leader in FDA-cleared consumer electrocardiogram technology (ECG), today announced two additional FDA 510(k)-cleared indications, making KardiaMobile the only consumer ECG device in the world with FDA-clearance to detect the three most common heart arrhythmias. In addition to detecting Atrial Fibrillation (AFib) and Normal Sinus […]

Infraredx, a Nipro Company, Announces FDA Approval of Expanded Label Claim for the Makoto™ Intravascular Imaging System

BURLINGTON, Mass.–(BUSINESS WIRE)–Infraredx, a Nipro Company, a pioneer in intravascular imaging for mapping coronary artery disease, announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to expand the indications for use for its Makoto™ Intravascular Imaging System. The approval is based on the […]

VisCardia Announces Completion of Enrollment and Three Month Follow-Up Visits for Its VisONE® Heart Failure Pilot Study

PORTLAND, Ore.–(BUSINESS WIRE)–VisCardia Inc., a privately held medical device developer, announced today it has completed enrollment and three month follow-up visits of the company’s VisONE® implantable system pilot for medical refractory heart failure patients with reduced ejection fraction and preserved ventricular synchrony. The VisONE Heart Failure pilot is a prospective […]

Cerenis Therapeutics has Decided to Terminate the Proposed Merger with H4Orphan Pharma

TOULOUSE, France–(BUSINESS WIRE)–Regulatory News: Cerenis Therapeutics (FR0012616852 – CEREN – PEA PME eligible), an international biopharmaceutical company dedicated to the discovery and development of HDL-based innovative therapies for treating cardiovascular and metabolic diseases, as well as new HDL-based vectors for targeted drug delivery in the field of oncology, announces that the […]

Surmodics Provides Update Regarding TRANSCEND Clinical Trial

EDEN PRAIRIE, Minn.–(BUSINESS WIRE)–Surmodics, Inc. (NASDAQ: SRDX), a leading provider of medical device and in vitro diagnostic technologies to the healthcare industry, has resumed patient enrollment into its TRANSCEND clinical trial and is nearly 75 percent of the way to its goal of 446 randomized patients. Patient enrollment in TRANSCEND, the […]

Quantum Genomics Receives First Regulatory and Ethics Approvals to Initiate Phase IIb QUORUM Study of Firibastat in Heart Failure

PARIS and NEW YORK, April 17, 2019 (GLOBE NEWSWIRE) — Quantum Genomics (Euronext Growth: ALQGC, OTCQX: QNNTF), a biopharmaceutical company specializing in the development of a new drug class that directly targets the brain to treat resistant hypertension and heart failure, today announced the first regulatory and ethics approvals for its Phase […]

HonorHealth Research Institute launches study to research benefit to patients at high risk of bleeding after coronary stent implantation

SCOTTSDALE, Ariz., April 16, 2019 /PRNewswire/ — HonorHealth Research Institute announced that the first patients have been enrolled in the SynIVUS-DAPT Study, a clinical study designed to test outcomes of decreasing the amount of time patients, with a high risk of bleeding, take antiplatelet medications after receiving a drug-eluting coronary stent. “People who […]

CDC Foundation, Amgen Announce Program to Increase Awareness and Knowledge of Cardiovascular Diseases Globally

ATLANTA, April 17, 2019 /PRNewswire/ — According to the World Health Organization (WHO), cardiovascular disease (CVD) is the leading cause of death worldwide, responsible for nearly 18 million deaths in 2016 alone. More than three-quarters of these deaths occur in low- and middle-income countries. To increase understanding of this globally important issue, […]

ABBOTT REPORTS FIRST-QUARTER 2019 RESULTS

ABBOTT PARK, Ill., April 17, 2019 /PRNewswire/ — Abbott (NYSE: ABT) today announced financial results for the first quarter ended March 31, 2019. First-quarter worldwide sales of $7.5 billion increased 2.0 percent on a reported basis and 7.1 percent on an organic* basis. Reported diluted EPS from continuing operations under GAAP was $0.38 in the first quarter. […]