Latest from Elizabeth Orr
The US FDA device center’s new annual report found notable successes in 2025 that included continuing to meet user fee goals as well as making progress on patient safety, innovation, and regulatory science.
Molecular diagnostics firm SAGA Diagnostics has introduced a colorectal cancer test that can detect even very low levels of cancer biomarkers. The test helps clinicians guide post-surgical treatment decisions.
The electrostimulation pain treatment firm reportedly shipped excessive supplies to patients for eight years, driving up revenues as well as stock prices.
The FDA has cleared Intuitive Surgical’s da Vinci 5 for some cardiac procedures, opening new opportunities for the firm. The company is also looking to expand its presence in ambulatory surgical centers, execs said during a Jan. 22 earnings call.
AdvaMed president Scott Whitaker said the group is focused on the need for tariff stability in conversations with the Trump administration. The organization remains optimistic about other policy areas. New chairman and ResMed CEO Mick Farrell laid out his five priorities.
The US FDA has sent warning letters to four companies that it says distribute HIV sample collection kits for home use without proper regulatory authorization.
