Brainlab is expanding its digital surgery portfolio with the FDA clearance for imaging and alignment module systems.
Brainlab AG announced on 22 February it received US Food and Drug Administration clearance for its Loop-X Mobile Imaging Robot and Cirq robotic alignment module for spine surgery.
Loop works with the company’s Brainlab digital surgery portfolio and can be integrated with customers’ existing surgical setups, according to the Munich-based company said.
The brunt of the tariff exposure stems from Singapore and Costa Rica, which together account for an estimated 70% to 80% of the tariff-related cost burden. Less than 10% of the exposure is tied to China.
A study from Babson Diagnostics published in the peer-reviewed Journal of Applied Laboratory Medicine showed that capillary blood sample volume issues can overcome historical challenges, such as poor quality, through a technique called assay miniaturization.
The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.
