medical device guru

Biologics, Wound Care, Infection Prevention
AVITA Medical’s “Spray-On Skin” Approved to Treat Serious Burns
AVITA Medical, a Valencia, California firm, won FDA approval for its remarkable RECELL Autologous Cell Harvesting Device for serious burns in adult patients. In preparation for treatment, a small healthy piece of the patient’s skin sample is taken, from which...
September 25, 2018
Surgery and Surgical Robotics
Medtronic to buy Mazor Robotics for $1.64 Billion
  Mazor Robotics Ltd., an Israeli biotech firm that develops robotic surgical systems, announced Friday it was being acquired by Irish-American medical device company Medtronic for a sum of $1.64 billion, the biggest-ever “exit” for an Israeli biotech company. Medtronic...
September 21, 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
Imaging Visualization & Navigation
Heidelberg Engineering wins FDA nod for OCT Angiography Module
The FDA has approved Heidelberg Engineering’s optical coherence tomography angiography module (OCTA), the company said today. The module is available for new and existing Spectralis upgradeable diagnostic imaging devices used to manage diabetic retinopathy, age-related macular degeneration and other macular diseases. OCTA is...
September 20, 2018
Surgery and Surgical Robotics
XACT Robotics Receives CE Mark for Robotic Navigation and Steering System
XACT Robotics, a pioneer in robotic navigation and steering solutions for percutaneous image-guided procedures, announced today that it has received CE Mark approval for its robotics navigation and steering system for image-guided percutaneous procedures, such as ablations and biopsies. The...
September 19, 2018
Surgery and Surgical Robotics
New Biomedical Review Finds Failure Rate in Some Surgical Mesh Treatments Unacceptably High
Failure rates in some treatments using surgical mesh are unacceptably high according to a newly published comprehensive biomedical review that considers the findings from peer-reviewed scientific articles assessing its use. In addition, the review concludes that more experiments should have...
September 18, 2018
Diagnostics & Healthcare News
Former Orlando Health Surgeon Files $100M Defamation Lawsuit Against the Health System 
A former plastic surgeon at Orlando Health has filed a $100 million defamation lawsuit against the health system, alleging that the hospital fired him without cause and made false statements about him, portraying him as “mentally and emotionally unstable.” In the lawsuit,...
September 12, 2018
Cardiovascular / Cardiology
New Apple Watch Will Have Built-In ECG, and It’s Already FDA Approved
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...
September 12, 2018
Cardiovascular / Cardiology
FDA Issues Warning Letters to Medtronic CRM Plants in Puerto Rico, Minnesota
The US Food and Drug Administration (FDA) issued two warning letters to Medtronic on Tuesday related to manufacturing nonconformities that resulted in a defibrillator recall earlier this year. The recall of the Medtronic Cardiac Resynchronization Therapy with Defibrillation (CRT-Ds) and...
September 12, 2018
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