medical device guru

Cardiovascular / Cardiology

Breakthrough Device Designation Given for preCARDIA’s Catheter Based Heart Failure Treatment

preCARDIA, Inc., has announced that the company’s catheter based system for treating volume overload in patients with acutely decompensated heart failure (ADHF) has been designated for the Breakthrough Devices Program by the U.S. Food and Drug Administration (FDA). The FDA’s...

June 23, 2020

Cardiovascular / Cardiology

First US Patients Treated Using the CardioFocus HeartLight X3 Ablation System

CardioFocus, Inc. today announced that the first U.S. patients have been treated commercially with the recently-approved HeartLight® X3 Endoscopic Ablation System. The revolutionary cardiac ablation technology is designed to treat drug refractory, symptomatic paroxysmal atrial fibrillation (AFib), the most common heart rhythm...

June 19, 2020

Cardiovascular / Cardiology

Neovasc Closes $11.5 Million Offering

Neovasc Inc. (“Neovasc” or the “Company”), a leader in the development of minimally invasive transcatheter mitral valve replacement technologies, and minimally invasive devices for the treatment of refractory angina, announced today that it has closed its previously announced registered direct...

June 17, 2020

Cardiovascular / Cardiology

Shockwave Medical Announces That CMS Has Created New Codes for Intravascular Lithotripsy

Shockwave Medical, Inc., a pioneer in the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease, announced today that the Centers for Medicare & Medicaid Services (CMS) has issued new codes for IVL procedures performed in...

June 11, 2020

Cardiovascular / Cardiology

VasQ External Support Awarded Breakthrough Device Designation by the FDA

The FDA has designated Laminate Medical’s VasQ™ External Support for the creation of arteriovenous fistulas (AVF) in hemodialysis patients as a Breakthrough Device. The FDA Breakthrough Device Program is intended to provide patients and doctors timely access to medical devices...

June 8, 2020

Cardiovascular / Cardiology

FDA Clears Innovative Angioplasty Scoring and Cutting Platform

Transit Scientific announced the FDA cleared the XO Score® Percutaneous Transluminal Angioplasty (PTA) Scoring Sheath platform for use in iliac, ilio-femoral, popliteal, infra-popliteal, and renal arterial plus synthetic and/or native arteriovenous hemodialysis fistula. Angioplasty is performed with expandable polymer balloon catheters...

June 4, 2020

Cardiovascular / Cardiology

Aesculap Inc. Announces U.S. Launch of M.blue Hydrocephalus Valve

Aesculap Inc., in partnership with The Christoph Miethke GmbH & Co. KG (MIETHKE), is pleased to announce the launch of the M.blue valve, the latest generation of Hydrocephalus valve technology. Its unique gravitational technology is integrated with a fixed differential...

June 3, 2020

Cardiovascular / Cardiology

FDA Issues Emergency Use Authorization for Impella RP as Therapy for COVID-19 Patients with Right Heart Failure

The United States Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for Impella RP to include patients suffering from COVID-19 related right heart failure or decompensation, including pulmonary embolism (PE). Abiomed (NASDAQ: ABMD) manufactures Impella RP. Impella RP is a...

June 1, 2020

Cardiovascular / Cardiology

Neovasc Has Filed for CE Mark for Tiara TA Transapical Mitral Valve Replacement System

Neovasc, Inc., a leader in the development of minimally invasive transcatheter mitral valve replacement technologies, and minimally invasive devices for the treatment of refractory angina, today announced that the Company has filed for CE Mark for its Tiara TA Transapical...

May 27, 2020