Posts by cstephenson@legacymedsearch.com
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 the so-called “Spray-On Skin” preparation is made. The process only takes 30 minutes, so it…
Read MoreMedtronic 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 previously owned an 11 percent stake in Mazor, which provides among its products a suite of…
Read MorePeople 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 study published in the September 19, 2018, online issue of Neurology, the medical journal of the…
Read MoreHeidelberg 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 a noninvasive imaging technique that provides three-dimensional visualization of perfused ocular vasculature. Structural OCT uses…
Read MoreXACT 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 Company also announced that it has raised $5 million in round C investment. The funds will mainly…
Read MoreNew 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 been conducted to properly assess how surgical mesh would behave in some of the bodily…
Read MoreFormer 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, filed last month in Orange County, Dr. Jeffrey Feiner, a reconstructive plastic surgeon, alleges that the…
Read MoreNew 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 boasts the first FDA approved direct to consumer ECG, or electrocardiogram, a medical device used…
Read MoreFDA 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 Implantable Cardiovert-Defibrillators (ICDs) models was initiated in January “due to a defect in the manufacturing…
Read MoreRobotic Ducks to Comfort Children in Hospitals
Aflac’s robotic therapy ducks have started waddling their way to children’s cancer hospitals nationwide after making their debut at CES earlier this year. The company is distributing the robotic waterfowl through a series of events as part of its activities for National Childhood Cancer Awareness Month. It started with the Aflac Cancer and Blood Disorders Center of Children’s…
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