We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The FDA published draft guidance June 19 to assist devicemakers in preparing for FDA's review of their premarket approval (PMA) applications and for coordinating inspections for PMA supplements.
A district court has upheld a jury verdict in favor of Boston Scientific in a patent infringement case against Cordis, a Johnson & Johnson (J&J) company.
The FDA issued a May 30 warning letter to Restorative Health Services of Nashville, Tenn., for current good manufacturing practices (cGMP) violations related to the firm's cranial orthosis device -- a "helmet" designed to prevent the continued development of an abnormally-shaped head.
Robert B. Ladd on behalf of Laddcap Value Partners LP announces that Delcath Systems, Inc.'s stockholders have overwhelmingly supported Laddcap's stockholder proposal recommending that Delcath's board retain a nationally recognized investment banking and/or merger advisory firm.
MobileAccess Networks, an enterprise wireless innovator, has announced an $11 million round of financing led by Ziegler Meditech Equity Partners (ZMEP), a private equity firm investing in the medical device and healthcare IT markets.
Biophan Technologies, Inc., a developer of next-generation medical technology, today announced that it is reducing the size of its board of directors from 7 to 5 members in order to have a majority of independent directors to satisfy one of the qualifications for listing on a major national stock exchange.
Maxxon, Inc., a growing medical products designer, manufacturer, and distributor concentrating on innovative Safety-engineered medical devices (SEMDs) that will have a price advantage over many competitors in the SEMDs arena, announces the results of Globe Med Tech's optimum retraction activation force user/lab study for its Maxxon 3cc Vacuum Operated Retractable Safety Syringe plunger.
Growth in sales for implantable cardioverter defibrillators (ICDs) has slowed in the United States, but Medtronic Inc. expects sales to gain speed throughout the year, an executive of the medical device maker said Tuesday.
Medical devicemaker Dermisonics has announced that it has received a Notice of Allowance from the U.S. Patent and Trademark Office for its second U-Strip patent application, concerning an ultrasonic drug-delivery system.