The U.S. FDA’s decision to grant breakthrough device designation for Bivacor Inc.’s titanium total artificial heart (TAH) sent real hearts aflutter at the Huntington, Calif.-based company’s headquarters. While the designation supports use of the TAH as a bridge to transplant for adults with biventricular or univentricular heart failure for whom current options are insufficient or unsuitable, Bivacor hopes its device will eventually serve as a long-term heart replacement.

The European Parliament (EP) has passed the Artificial Intelligence Act (AI Act), bringing the legislation one step closer to full passage into law, with passage by the European Council the only remaining hurdle.

People who can’t verbalize their pain often end up being under medicated, and Painchek Ltd. uses artificial intelligence (AI) to identify the presence of pain even when it may not be obvious. This gives a voice to those who cannot verbalize pain, while also driving objectivity and consistency in pain assessments.