Cardiovascular / Cardiology

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 in heart attack patients. SSO2 Therapy delivers hyperbaric levels of oxygen directly to the ischemic…

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 quickly assess patients presenting with chest pain, helping with triage and getting patients to receive…

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 address a significant unmet medical need in heart failure, the Optimizer Smart System received Breakthrough…

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 sonographer to use Doppler ultrasound, but now a new option is available. Sonavex, a company…

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 Early Bird Bleed Monitoring System. According to a recent study of over 17,000 large-bore transcatheter…

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 result in a lack of pacing. Patients and physicians cannot predict whether and when this…

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 that uses Peripheral Arterial Tone technology, providing cardiologists and sleep physicians in the United States…

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 investment groups and the company’s traditional shareholders — Sofimac Innovation, Business Angels des Grandes Ecoles, Paris…

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 study published in the September 19, 2018, online issue of Neurology, the medical journal of the…

At Apple’s annual September hardware launch event, Apple revealed a major medical advancement added to their newest update in the Apple Watch line: the Apple Watch Series 4. Among other updates including a larger screen and smaller bezel, the system boasts the first FDA approved direct to consumer ECG, or electrocardiogram, a medical device used…