Device Pipeline and Approvals

Device can now be used in patients with symptomatic moderate-to-severe or severe mitral regurgitation who are not candidates for surgery or transcatheter edge-to-edge repair therapy.

RSP Systems achieves major milestone in non-invasive glucose monitoring technology

Clearance is the first AI platform for real-time surgical measurements, marking major leap in operating room innovation

The company also expects to submit its application for 510(k) clearance for its OneRF Trigeminal Nerve Ablation System in May, sooner than expected.

Inovalon’s Safety Management solution now on PointClickCare Marketplace

Test is designed for females regardless of symptoms and gives results in about 30 minutes

Media report highlights how FDA workloads have increased, and delays for new technology approvals will likely suffer

FDA approves Dawes-Redman CTG analysis for U.S. use, enhancing fetal monitoring

AdvaMed, Senate Democrats warn of regulatory slowdowns and public health threats following mass layoffs at the FDA.

Triage solution is built on existing AI engine

Autonomous solution doesn’t require dilation in vast majority of cases