Device Pipeline and Approvals

This is the first time an implantable, long-term EEG monitoring device has been authorized for use in the United States.

The company received the designation for its atrioventricular interval modulation therapy, a novel pacemaker-based treatment aimed at reducing blood pressure in patients with uncontrolled hypertension and elevated cardiovascular risk.

Device uses an adaptive algorithm to automatically adjust and correct glucose levels every five minutes around the clock.

Adagio Medical Receives FDA Breakthrough Device Designation for its Cryoablation System that targets VT

The newly cleared system uses advanced identification and antimicrobial susceptibility testing algorithms to support the interpretation of complex microbiological data.

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