medical device guru

Cardiovascular / Cardiology

Medinol Receives FDA Approval for Next Generation EluNIR-PERL™ Drug-Eluting Coronary Stent System

Medinol today announced United States Food and Drug Administration (FDA) approval for the EluNIR-PERL™ drug-eluting stent (DES) for the treatment of coronary artery disease. EluNIR-PERL builds upon the proven performance and clinical data of the EluNIR™ DES system. As the latest evolution...

October 30, 2023

Cardiovascular / Cardiology

Advanced Bifurcation Systems Inc. Receives FDA Breakthrough Device Designation

Advanced Bifurcation Systems Inc. (ABS), a pioneer in comprehensive solutions for bifurcation lesions in coronary angioplasty, today announced that it has received the Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its novel coronary artery bifurcation...

October 24, 2023

Cardiovascular / Cardiology

Pleural Dynamics Receives FDA 510(k) Clearance for its Novel ACES™ Automatic Continuous Effusion Shunt System

Pleural Dynamics, a medical device company that is building solutions for chronic, recurrent fluid collections in the body, today announced that the Company has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the ACES™ Automatic Continuous Effusion Shunt...

October 19, 2023

Cardiovascular / Cardiology

Cardio Flow, Inc., Announces U.S. Food and Drug Administration (FDA) 510(k) Clearance for its FreedomFlow® Orbital Atherectomy Peripheral Platform

Cardio Flow, Inc., a privately held medical device company and developer of minimally invasive devices to treat peripheral artery disease (PAD), today announced it recently received U.S. Food and Drug Administration (FDA) 510(k) clearance for the company’s FreedomFlow Orbital Atherectomy...

October 18, 2023

Cardiovascular / Cardiology

FDA Grants ExThera Multiple Breakthrough Device Designations for its Seraph® 100 Filter

ExThera Medical Corporation, a healthcare company developing and manufacturing extracorporeal pathogen technologies, announces that it has received multiple Breakthrough Device Designations from the U.S. Food and Drug Administration (FDA), for its Seraph® 100 Microbind® Affinity Blood Filter (Seraph 100). The...

October 3, 2023

Cardiovascular / Cardiology

QT Medical® Announces Completion of Series B Financing of $12 Million

QT Medical, Inc., a medtech company focused on cardiac care technology, announced today that it raised $12 million in Series B financing. This funding will accelerate QT Medical’s market penetration, global expansion, product pipeline development, and long-term strategic planning. QT Medical aims to...

September 27, 2023

Cardiovascular / Cardiology

Inspira™ Announces 510(k) FDA Submission of INSPIRA™ ART100 Towards Commercialization

Inspira™ Technologies OXY BHN Ltd. (Nasdaq: IINN, IINNW) (the “Company” or “Inspira Technologies”), a company aiming to bring a paradigm shift to acute respiratory care by empowering breathing without lungs, announced it had submitted its INSPIRA ART 100, a cardio-pulmonary bypass device,...

September 13, 2023

Cardiovascular / Cardiology

FDA Approves LimFlow System in Patients With Chronic Limb-Threatening Ischemia and No Suitable Endovascular or Surgical Revascularization Options

LimFlow SA, a pioneer in the development of minimally-invasive technology for the treatment of chronic limb-threatening ischemia (CLTI), a severe form of peripheral artery disease (PAD), announced today that the U.S. Food and Drug Administration (FDA) has approved the LimFlow...

September 12, 2023

Cardiovascular / Cardiology

Aquedeon Medical, Inc. Receives FDA IDE Approval for the Duett Vascular Graft System

Aquedeon Medical, Inc., a Silicon Valley pioneering medical device company specializing in novel cardiothoracic solutions, is pleased to announce a significant milestone following receipt of FDA Investigational Device Exemption (IDE) approval to conduct a staged pivotal clinical trial for its...

September 8, 2023