This week on Trying to Keep Up, Allison Komiyama and Michael Nilo celebrate a holiday-week edition of the podcast while unpacking several important developments affecting medical device and biotechnology companies.

They discuss two newly approved PMAs, including Artivion's hybrid prosthesis for treating acute Type A aortic dissections and LungFX's Centralized Lung Evaluation System, designed to evaluate previously unacceptable donor lungs for transplantation. They also highlight FDA's expanded approval of Casgevy, making the groundbreaking gene therapy available to children as young as two years old with sickle cell disease or transfusion-dependent beta thalassemia.

The conversation also covers:

• FDA's TAP Program now enrolling devices across all OHTs

• eMDR system enhancements and adverse event reporting improvements

• Changes to FDA's Clinical Decision Support Software FAQs following ONC's HTI-1 predictive decision support rule

• Organ preservation technologies and transplantation innovation

• Upcoming RegAF Conference updates