Posts by rw-admin
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 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…
Read MoreStryker to acquire K2M for $1.4B
Stryker said today it inked a definitive agreement to acquire K2M for approximately $1.4 billion. In the deal, Kalamazoo, Mich.-based Stryker said it will pay $27.50 per share for each outstanding share of K2M, for a total of approximately $1.4 billion. The purchase price represents a 27% premium over K2M’s average closing price during the 90 days of…
Read MoreWright Medical to Buy Orthopaedic Company Cartiva for $435M
Wright Medical Group announced it has entered into a definitive agreement to acquire Cartiva, Inc., a private orthopaedic medical device company focused on treatment of osteoarthritis of the great toe. The transaction will add a differentiated PMA-approved technology for a high-volume foot and ankle procedure and further accelerates growth opportunities in Wright’s global Extremities business. Under…
Read MoreFDA Warning Letter Issued to Zimmer Biomet’s Indiana Manufacturing Site
Zimmer Biomet received a warning letter from the FDA about quality violations found at a plant in Warsaw, Indiana. The agency had flagged the issues after a 2016 inspection of the site, but found in a re-inspection earlier this year that the company’s resolution was not up to par. The FDA inspected Zimmer Biomet’s North…
Read MoreRevolution in Electrocardiography Long in Coming, but MyoVista Fills the Bill
“Revolutionary!” and “Transformative!” are tossed around like so much jetsam in today’s spotlight-driven culture, and the medical field is not immune. But we believe a product that harvests multiple indicators of heart disease from a simple, inexpensive, first-line test has earned these superlatives. MyoVista wavECG by HeartSciences, which we saw introduced at this year’s ACC.18…
Read MoreFDA Approval for Ceterix Orthopaedics New Suture Cartridge
Ceterix® Orthopaedics, Inc., a leader in the development of cutting-edge surgical tools for orthopaedic surgeons, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of an added feature to the NovoStitch® Pro Meniscal Repair System – a size 0 suture cartridge – offering surgeons more options to repair meniscal tears. The NovoStitch Pro system enables…
Read MoreFDA grants Breakthrough Device status for Dthera’s Alzheimer’s Treatment
Dthera™ Sciences, the leading digital therapeutic company focusing on the elderly and individuals with neurodegenerative diseases, announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation to the Company’s development-stage product, DTHR-ALZ. DTHR-ALZ, if granted approval, would become the first non-pharmacological prescription treatment for the symptoms of Alzheimer’s disease. The…
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