Archive for September 2018
Cardiawave raises $8.2 million for non-invasive aortic stenosis device
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…
Read MoreFDA Clears Leica’s Augmented Reality Neurosurgical Visualization Solution
Last week, Leica Microsystems received 510(k) clearance from the U.S. Food and Drug Administration to market its augmented reality GLOW800 surgical fluorescence for vascular neurosurgery. In combination with ICG (Indocyanine Green), GLOW800 allows surgeons to observe cerebral anatomy in natural color, augmented by real-time vascular flow in a single image, with full depth perception. This…
Read MoreINSIGHTEC Receives FDA Approval for Exablate Neuro Compatibility with Siemens Healthineers MRI Scanners
INSIGHTEC®, a global medical technology innovator of incisionless surgery, today announced that the U.S. Food and Drug Administration has approved Exablate Neuro™ compatibility for the state-of-the-art MRI Scanners Magnetom Skyra, Prisma and Prismafit from Siemens Healthineers to treat patients with essential tremor. “This important milestone is directly attributed to the commitment and collaboration of the teams at INSIGHTEC and Siemens Healthineers,…
Read MoreAVITA 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…
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