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

Diagnostics & Healthcare News

Itamar Medical Launches Next-Generation WatchPAT System for Home Sleep Apnea Testing

Itamar Medical Ltd., a company that develops, manufactures and markets non-invasive diagnostic medical devices for sleep apnea with a focus on the cardiology market, today announced the launch of WatchPAT 300, the next generation WatchPAT system for home sleep apnea...

March 27, 2019

Surgery and Surgical Robotics

Zimmer Biomet Receives FDA Clearance for Robotic ROSA One Spine System

Zimmer Biomet Holdings, Inc., a global leader in musculoskeletal healthcare, today announced U.S. Food and Drug Administration 510(k) clearance of the ROSA® ONE Spine System for robotically assisted minimally invasive and complex spine surgeries, strengthening the Company’s comprehensive ROSA® ONE Brain and...

March 25, 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

Orthopedics and Spine

Stryker Acquires Rotator Cuff Device Maker OrthoSpace

Stryker announced today it has completed the acquisition of OrthoSpace, Ltd., a privately held company founded in 2009 and headquartered in Caesarea, Israel, in an all cash transaction for an upfront payment of $110 million and future milestone payments of...

March 14, 2019

Biologics, Wound Care, Infection Prevention

Smith & Nephew to Buy Osiris Therapeutics for $660 Million

Smith & Nephew said today that it agreed to put $660 million on the table to acquire Osiris Therapeutics and its regenerative medicine portfolio. The British orthopedics and wound care giant said the $19-per-share deal is a 37% premium on the 90-day volume-weighted...

March 12, 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