FDAnews Device Daily Bulletin

Developers of medical device mobile apps don’t just need to worry about the FDA’s advertising and promotion regulations, they also must ensure any marketing claims comply with a new FTC guideline.

A public-private partnership looking to speed introduction and coverage of new medical technologies in Canada is expanding, as three devices involved in the initial phase of the program are being readied for premarket evaluation to build evidence for approval and adoption.

Medtronic must try again to prove that it didn’t infringe two patents controlled by Boston Scientific over implantable defibrillators, a U.S. appeals court said.

The FDA has approved the first ultrasound device to detect breast cancer in women with dense breast tissue, for use along with standard mammography for women with no symptoms of breast cancer, the agency said.

Ariosa Diagnostics Inc. filed a petition for inter partes review Monday asking the U.S. Patent and Trademark Office to invalidate a prenatal blood test patent that Sequenom Inc. accuses Ariosa of infringing.

Johnson & Johnson today announced plans to establish four regional innovation centers in major life sciences communities in the world as part of a novel approach to accelerate early innovation and enhance opportunities for collaboration and investment across its global healthcare businesses.

Through its licensing partner, AngioDynamics, IBI has just cleared a major regulatory hurdle that will allow a medical device using its polymer-based additives to be used in the United States.

Swedish Medical Center has become the first advanced care center in the state to bring an innovative medical device to its stroke care protocol, aimed at treating ischemic stroke patients faster and more efficiently than ever before.