Archive for September 2018
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 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…
Read MoreBoston Scientific to acquire Augmenix for up to $600M
Boston Scientific said yesterday that it put $600 million on the table for Augmenix and its SpaceOar device. The deal for Bedford, Mass.-based Augmenix calls for $500 million in up-front cash and another $100 million pegged to sales-based milestones, Boston said. The SpaceOar hydrogel device, which won CE Mark approval in the European Union in 2010 and 510(k) clearance from…
Read MoreIntuitive Surgical Submits New Robotic-Assisted Platform to FDA for Obtaining Lung Biopsies
Intuitive Surgical, Inc., the pioneer and a global technology leader in robotic-assisted, minimally invasive surgery, today announced it has submitted a premarket notification to the U.S. Food and Drug Administration (FDA) for the company’s new flexible robotic-assisted, catheter-based platform, designed to navigate through very small lung airways to reach peripheral nodules for biopsies. Lung cancer is the…
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