Author: Ken Dropiewski

Cardio Diagnostics Holdings, Inc. Receives Final Medicare Pricing Determination from Centers for Medicare and Medicaid Services (CMS) for AI-Powered Cardiovascular Tests

CHICAGO–(BUSINESS WIRE)–Cardio Diagnostics Holdings, Inc. (NASDAQ: CDIO), an AI-driven precision cardiovascular medicine company today announced that the Company’s PrecisionCHD and Epi+Gen CHD tests have received final pricing determinations from the Centers for Medicare & Medicaid Services (CMS). Following the preliminary pricing determination made by CMS in August 2024, CMS finalized the […]

LeMaitre Vascular Announces Proposed Convertible Senior Notes Offering

BOSTON, Dec. 16, 2024 (GLOBE NEWSWIRE) — LeMaitre Vascular, Inc. (“LeMaitre”) (Nasdaq: LMAT) today announced its intention to offer, subject to market and other conditions, $150,000,000 aggregate principal amount of Convertible Senior Notes due 2030 (the “notes”) in a private offering (the “offering”) to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the “Securities Act”). LeMaitre also expects to grant the initial purchasers of the notes an option to purchase, for settlement within a period of 13 days from, and including, the date the notes are first issued, up to an additional $22,500,000 aggregate principal amount of notes.

ACTION Centers Collaborate with Johnson & Johnson MedTech to Secure FDA Labeling for Impella Support System in Pediatric Patients

CINCINNATI, Dec. 13, 2024 /PRNewswire/ — In a groundbreaking achievement for pediatric heart care, the FDA has expanded the labeling of Johnson & Johnson MedTech’s Impella Support System to include treatment for certain children suffering from heart failure, extending the original…

InspireMD Announces Expected Retirement of its CFO Craig Shore and CFO Transition in 2025

MIAMI, Dec. 12, 2024 (GLOBE NEWSWIRE) — InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for the prevention of stroke, today announced that Craig Shore, Chief Financial Officer, has decided to retire from the Company after a successor CFO is identified and appointed. Mr. Shore will remain as CFO until his successor is appointed and will assist in a smooth and orderly transition.

RapidPulse Receives FDA Approval to Begin IDE Study in Ischemic Stroke Using Innovative Cyclic Aspiration System – Recently Completed Clinical Trial Shows Significantly Higher First Pass and Frontline Success Rates

MIAMI, Dec. 11, 2024 (GLOBE NEWSWIRE) — RapidPulse, Inc., a Delaware corporation headquartered in Miami, Florida focused on improving the treatment success rate for acute ischemic stroke (AIS) announced that the United States Food and Drug Administration (FDA) agreed that RapidPulse can begin enrollment in an Investigational Device Exemption (IDE) study of its novel and precise cyclic aspiration system. This will allow U.S. and European patient enrollment in 2025 to commence in a study designed to demonstrate the RapidPulse patented method of precisely pulsed aspiration is safe and effective in the treatment of AIS. RapidPulse’s technology is a spin-out of Syntheon 2.0, LLC, an innovative medical device incubator with a long track record of successful exits.

Genetesis Launches CardioFlux Membership Program to Revolutionize Preventive Cardiac Care and Eliminate Heart Disease

Proactive, personalized monitoring of myocardial fitness at regular intervals, powered by MCG technology, represents paradigm shift in the prevention of heart disease City of Mason’s Biohealth Corridor selected as home of first ever CardioFlux Imaging Institute MASON, Ohio, Dec. 11, 2024…

IRADIMED CORPORATION on Forbes’ List of America’s Most Successful Small-Cap Companies for 2025

WINTER SPRINGS, Fla., Dec. 10, 2024 (GLOBE NEWSWIRE) — IRADIMED CORPORATION (the “Company”) (NASDAQ: IRMD), today announced it has been ranked 24th on Forbes’ list of America’s Most Successful Small-Cap Companies 2025. Iradimed is a leader in the development of innovative magnetic resonance imaging (“MRI”) medical devices and the only provider of a non-magnetic intravenous (“IV”) infusion pump system and non-magnetic patient vital signs monitoring systems that are designed for use during MRI procedures.