Cochlear Ltd., of Sydney, received U.S. FDA approval for its Nucleus Profile Plus cochlear implant and the Nucleus 7 sound processor's new built-in connectivity, enabling direct streaming with compatible Android smartphones. The implant will be commercially available in the U.S. later this month. Read More
The widespread use of nitinol in medical devices has afforded patients a range of implants with remarkable elasticity. However, the U.S. FDA draft guidance regarding technical considerations for the use of nitinol in these devices drew a substantial amount of commentary on several points. Among the issues cited by multiple stakeholders was the description of requirements for testing for pitting and for transformation temperatures, suggesting the agency will have to revisit this draft extensively before the final form will be available to manufacturers of stents and artificial valve devices. Read More
A fast response with cardiopulmonary resuscitation (CPR) for cardiac arrest victims can save their lives, but older adults often are alone in their home or a bedroom when symptoms strike. Researchers at the University of Washington (UW) have developed a machine learning-based system that listens to ambient audio via dedicated smart speakers or smartphones for agonal breathing, the distinctive sound that a person in cardiac arrest makes. Read More
