medical device guru

Cardiovascular / Cardiology

FDA Approves First New Therapy to Treat Heart Attacks in Years

TherOx Inc. announced that the U.S. Food and Drug Administration (FDA) granted premarket approval for its SuperSaturated Oxygen (SSO2) Therapy. SSO2 Therapy provides interventional cardiologists with the first and only FDA-approved treatment beyond percutaneous coronary intervention (PCI) to significantly reduce muscle damage...

April 8, 2019

Cardiovascular / Cardiology

Genetesis CardioFlux Platform Receives FDA 510(k) Clearance

Genetesis, a company based in Mason, Ohio, won FDA clearance for its cardiac imaging offering that combines the CardioFlux magnetocardiograph with the the integrated Faraday Analytical Cloud (FAC). The technology is intended to be used by ER physicians and cardiologists to...

April 2, 2019

Cardiovascular / Cardiology

FDA Approves Breakthrough Optimizer Smart Device for Chronic Heart Failure

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...

March 21, 2019

Cardiovascular / Cardiology

Sonavex Receives FDA Clearance for Blood Flow Monitoring Technology

Following peripheral vascular and microvascular surgeries, it is important to be able to monitor how blood is flowing through the treated vessels and whether there may be an occlusion or compromise. This monitoring typically requires a nurse or a trained...

March 18, 2019

Cardiovascular / Cardiology

Saranas Achieves De Novo FDA Clearance for Their Endovascular Monitoring System

Saranas Inc., a medical device company with innovative technology for real-time detection and monitoring of internal bleeding during endovascular procedures, today announced that it has been granted de novo classification by the U.S. Food and Drug Administration (FDA) for the...

March 6, 2019

Cardiovascular / Cardiology

Massive Medtronic Pacemaker Recall is Class I Says FDA

The FDA has slapped the most serious designation on a recall of approximately 156,957 Medtronic dual-chamber pacemakers. The Fridley, Minn.-based company issued a recall in January on pacemakers with model names Adapta, Versa, Sensia, Relia, Attesta, Sphera, and Vitatron due to a software error that can...

February 18, 2019

Cardiovascular / Cardiology

Itamar Medical Gets Favorable CMS Reimbursement Decision for WatchPAT Technology

Itamar Medical Ltd. today announced the release of the 2019 Fee Schedule from the U.S. Centers for Medicare & Medicaid Services (CMS) that should support broad use of its WatchPAT technology. WatchPAT is the only product on the market today...

November 9, 2018

Cardiovascular / Cardiology

Cardiawave raises $8.2 million for non-invasive aortic stenosis device

Parisian startup Cardiawave has raised more than $8 million to boost development of its ultrasound device to treat calcific aortic stenosis. Nearly $3 million came from the European program Instrument PME, which finances disruptive European technologies developed by potentially high-growth companies. Family-controlled...

September 28, 2018

Cardiovascular / Cardiology

People who walk just 35 minutes a day may have less severe strokes

People who participate in light to moderate physical activity, such as walking at least four hours a week or swimming two to three hours a week, may have less severe strokes than people who are physically inactive, according to a...

September 20, 2018