medical device guru

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: 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
Surgery and Surgical Robotics
FDA Warns Against Using Surgical Robots in Cancer Surgeries
The Food and Drug Administration on Thursday warned against the use of robotically assisted devices for mastectomies and other cancer surgeries, asserting the products may pose safety risks and result in poor outcomes for patients. The agency said it decided to issue...
March 4, 2019
Surgery and Surgical Robotics
Axilum Wins 510(k) Clearance for Robotic TMS System
Axilum Robotics, which specializes in the development of medical robots, announced that two weeks after the CE mark, it has received 510(k) clearance from the U.S. Food and Drug Administration to market the TMS-Cobot TS MV for the spatial positioning and...
February 27, 2019
Surgery and Surgical Robotics
Intuitive Surgical Gains FDA Clearance for Lung Cancer Biopsy Robot
Intuitive Surgical Inc. said last week that the U.S. Food and Drug Administration has cleared its Ion system. The robotic endoluminal system is designed to enable doctors to conduct minimally invasive biopsies deep within the lung. Ion includes an articulating...
February 25, 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
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