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Diagnostics & Healthcare News

Boston 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....

September 7, 2018

Surgery and Surgical Robotics

Intuitive 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...

September 6, 2018

Orthopedics and Spine

Stryker 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...

August 30, 2018

Orthopedics and Spine

Wright 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...

August 30, 2018

Orthopedics and Spine

FDA 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...

August 28, 2018

Cardiovascular / Cardiology

Revolution 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...

August 28, 2018

Orthopedics and Spine

FDA 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...

August 28, 2018

Diagnostics & Healthcare News

FDA 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...

August 24, 2018

Cardiovascular / Cardiology

Vascular Changes after Smoking Hookah on par with Cigarettes

Smoking hookah for 30 minutes causes changes in arterial stiffness similar to what’s seen after someone smokes a cigarette, according to a study published in the American Journal of Cardiology. “Our findings challenge the concept that fruit-flavored hookah tobacco smoking is a healthier...

August 24, 2018