Other News

Genetesis CardioFlux™ Platform Receives FDA 510(k) Clearance

MASON, Ohio–(BUSINESS WIRE)–Genetesis, a medical technology company focused on using biomagnetic imaging to enable rapid, noninvasive and accurate chest pain triage, has received FDA 510(k) clearance for its cardiac imaging platform. The platform pairs the CardioFlux™ Magnetocardiograph with the integrated Faraday Analytical Cloud™ (FAC). “This milestone provides emergency room physicians […]

Healogics® Brings Vein Ablation Services to Wound Care Centers®

JACKSONVILLE, Fla., March 21, 2019 /PRNewswire/ — Healogics, the nation’s largest provider of advanced chronic wound care services, today announced they have added vein ablation to their in-house service offerings through a new program called Healogics® VeinCare. This program allows Healogics to provide patients with a higher level of care in a more […]

BD Statement on Paclitaxel-Coated Devices

FRANKLIN LAKES, N.J., March 21, 2019 /PRNewswire/ — BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today issued the following statement related to the recent letter from FDA to health care providers regarding paclitaxel-coated devices: On March 15, the FDA issued a letter to health care providers regarding paclitaxel-coated devices […]

Neovasc Announces Fourth Quarter and Fiscal Year 2018 Financial Results

VANCOUVER, March 21, 2019 /PRNewswire/ – Neovasc, Inc. (“Neovasc” or the “Company”) (NASDAQ, TSX: NVCN), a leader in the development of minimally invasive transcatheter mitral valve replacement technologies and in the development of minimally invasive devices for the treatment of refractory angina, today reported financial results for the fourth quarter and fiscal […]

Impulse Dynamics Receives FDA Approval for Breakthrough Optimizer® Smart System Delivering CCM™ Therapy for Treatment of Heart Failure

ORANGEBURG, New York, March 21, 2019 /PRNewswire/ — Impulse Dynamics, developer of the implantable Optimizer® Smart System for delivering CCM™ therapy, announced today that it has received approval from the United States Food and Drug Administration for its first-in-class Optimizer Smart System (link to FDA announcement:  https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm634103.htm). Designed to address a significant unmet […]

Endologix Reports Inducement Grants Under NASDAQ Listing Rule 5635(c)(4)

RVINE, Calif.–(BUSINESS WIRE)–Endologix, Inc. (Nasdaq:ELGX) (the “Company”), a developer and marketer of innovative treatments for aortic disorders, announced today the grant of inducement equity awards to nine newly hired employees (the “Awardees”). The awards were approved by the Company’s Compensation Committee, which is comprised of independent Directors, on March 13, 2019, as […]

FDA approves new device for treating moderate to severe chronic heart failure in patients

SILVER SPRING, Md., March 21, 2019 /PRNewswire/ — The U.S. Food and Drug Administration today approved the Optimizer Smart system for treating patients with chronic, moderate-to-severe heart failure who are not suited for treatment with other heart failure devices such as cardiac resynchronization therapy to restore a normal timing pattern of the heartbeat. […]

Neovasc Wins German Court Appeal; Announces German Court’s Decision to Dismiss CardiAQ’s Claim to Co-inventorship of a European Patent for Tiara™

VANCOUVER, March 21, 2019 /PRNewswire/ – Neovasc Inc. (“Neovasc” or the “Company”) (NASDAQ: NVCN)(TSX: NVCN), a leader in the development of minimally invasive transcatheter mitral valve replacement technologies and in the development of minimally invasive devices for the treatment of refractory angina, today announced that the Higher Regional Court in Munich, Germany, on appeal […]

Vixiar Medical Raises $1.5 Million in Additional Financing

BALTIMORE–(BUSINESS WIRE)–Vixiar Medical, Inc., a privately held Maryland company dedicated to the development of non-invasive devices and systems for monitoring cardiopulmonary diseases, announced today that it closed its most recent financing of $1.5 million from new and existing investors. Proceeds will be used to complete an ongoing clinical trial and […]

Zenosense, Inc.: Update on MIDS Medical Test Strip Development

VALENCIA, SPAIN, March 20, 2019 (GLOBE NEWSWIRE) — via NEWMEDIAWIRE — Zenosense, Inc. (OTCQB: ZENO, “Zenosense”, the “Company”), a healthcare technology company focused on the development and commercialization of the MIDS Cardiac™ hand-held technology for the early detection of heart attack at the Point of Care, is pleased to announce an […]