Regulatory

Sequana Medical announces FDA approval to expand patient enrolment in North American pivotal alfapump® study (POSEIDON)

Completion of patient enrolment expected before end of year Primary endpoint read-out due in Q4 2022 59 patients already recruited in the Pivotal Cohort Ghent, Belgium – 4 October 2021 – Sequana Medical NV (Euronext Brussels: SEQUA, the “Company”), an innovator in the treatment of diuretic-resistant fluid overload in liver […]

FDA Clears First Major Imaging Device Advancement for Computed Tomography in Nearly a Decade

SILVER SPRING, Md., Sept. 30, 2021 /PRNewswire/ — Today, the U.S. Food and Drug Administration cleared the first new major technological improvement for Computed Tomography (CT) imaging in nearly a decade. “Computed tomography is an important medical imaging tool that can aid in diagnosing disease, trauma or abnormality; planning and guiding interventional or […]

FDA Approval and First Implant of Orsiro Mission Drug-Eluting Stent System in the U.S.

Full Commercial Launch Underway for One of the Most Studied and Thinnest Strut Drug-Eluting Stents, Offering Enhanced Deliverability LAKE OSWEGO, Ore., Sept. 29, 2021 /PRNewswire/ — BIOTRONIK announced today it received U.S. Food and Drug Administration (FDA) approval of its Orsiro® Mission bioabsorbable polymer drug-eluting stent system (BP-DES). The company also announced the first U.S. […]

FDA Clears Caretaker Medical’s Wireless Platform for Continuous Noninvasive Blood Pressure and Hemodynamic Monitoring

Innovative Next-Generation Technology Monitors the Most Important Vital Signs for Cardiovascular Health CHARLOTTESVILLE, Va.–(BUSINESS WIRE)–Caretaker Medical, a pioneer in wireless “beat by beat” continuous, non-invasive, advanced patient monitoring, today announced U.S. Food and Drug Administration (FDA) clearance of the company’s next-generation VitalStream™ wireless blood pressure and hemodynamic monitoring platform. Continuous […]

Nanowear Receives FDA 510(k) Platform Clearance to Implement Forthcoming AI-based Diagnostics in its Closed Loop Hospital-at-Home Network

NEW YORK–(BUSINESS WIRE)–Nanowear, a leading hospital-at-home and remote diagnostic platform informed by proprietary cloth nanotechnology and AI, today announced that it received its third FDA 510(k) clearance and first software-only clearance as an end-to-end digital platform, illustrating unique capabilities available to enterprise customer channels across a broad spectrum of diagnostic […]

Zebra Medical Vision Secures 8th FDA Clearance for its Coronary Artery Calcium (CAC) Solution as Part of Its Population Health Offering

This latest milestone helps Zebra-Med expand its mission of screening populations at scale with its AI-based solutions, promoting early and preventative healthcare treatment. The CAC solution analyzes already existing non-gated CT scans and quantifies the coronary artery calcium in order to identify, stratify, and facilitate treatment pathways for patients with […]

Baxter Announces U.S. FDA Approval and Launch of Ready-to-use Cardiovascular Medicine Norepinephrine in Premix Formulation

First and only manufacturer-prepared premix formulation of norepinephrine available Offers variety of storage options under refrigeration and at room temperature, allowing drug to be placed closer to patient care settings Ready-to-use format means less chance of compounding errors and touch contamination associated with compounded drug formulations DEERFIELD, Ill.–(BUSINESS WIRE)–Baxter International […]

FDA APPROVES ABBOTT’S EPIC™ PLUS TISSUE VALVES FOR PEOPLE IN NEED OF MITRAL OR AORTIC VALVE REPLACEMENT

– New enhancements to Abbott’s Epic valve – the most widely used mitral tissue heart valve in the U.S. and globally – can improve implantation and allow compatibility for future transcatheter valve procedures – Epic Plus designed to help patients with more complex cases of aortic or mitral regurgitation or […]

Abbott Receives FDA Approval for Minimally Invasive Portico™ with FlexNav™ TAVR System to Treat Patients with Aortic Valve Disease

– Transcatheter aortic valve replacement (TAVR) procedure treats people with symptomatic, severe aortic stenosis who are at high or extreme risk for open-heart surgery – With Portico approval, Abbott offers the industry’s most comprehensive portfolio of structural heart solutions in the U.S. ABBOTT PARK, Ill., Sept. 20, 2021 /PRNewswire/ — Abbott (NYSE: ABT) […]

Neovasc Announces FDA Approval of COSIRA-II Clinical Trial

Company on Schedule to Commence Trial Late This Year VANCOUVER and MINNEAPOLIS, Sept. 16, 2021 (GLOBE NEWSWIRE) — via NewMediaWire — Neovasc Inc. (“Neovasc” or the “Company”) (Nasdaq, TSX: NVCN) announced today that it has received FDA approval for the Investigational Device Exemption (“IDE”) regarding the COSIRA-II IDE Clinical Trial. Following multiple discussions with FDA […]