Device Pipeline and Approvals

FDA clears Life Spine's VersaLift expandable interbody system, featuring a 6mm starting height for constrained anatomy

EchoNext, developed by Pathway Labs, is now available on OpenEvidence after receiving FDA clearance for six indications

New AI-powered sensor on Radius VSM flags early signs of opioid-induced respiratory depression in hospitalized patients

Clearance extends the company's near-infrared fluorescence imaging to open procedures in the U.S., letting surgical teams add ICG visualization without new capital investment.

The spinal fixation system is designed to provide surgeons with a modular platform that can be customized for a wide range of patient anatomies and surgical procedures, including complex deformity and revision cases.

South Korean company plans U.S. launch through partnership with sensor technology firm

Software platform uses consumer smartwatches and blood pressure cuffs to estimate cardiac hemodynamics for heart failure patients at home

AI-powered software estimates cardiac pressure noninvasively through wearable sensor

New device adds airflow, oxygen and snoring analysis capabilities to chin-worn home testing platform

Device is intended to provide rapid nerve identification and functional evaluation for both large and small nerves during surgery

System uses a non-invasive focused ultrasound technology designed to mechanically liquefy and destroy targeted tissue without surgery, radiation or thermal energy.

Clearance authorizes use of the system by qualified and trained healthcare professionals and marks a key regulatory milestone for the company as it expands its artificial intelligence-enabled imaging platform.

Rapid Medical says its TIGERTRIEVER 25 device is designed to improve clot retrieval in difficult large vessel occlusions, as advances in mechanical thrombectomy continue to expand stroke treatment options

Device is intended for use in minimally invasive cardiac procedures that require access to the left atrium, a critical but technically challenging step in many structural heart and electrophysiology interventions.

Device expands treatment options for high-risk patients with complex aortic conditions, reflecting broader advances in endovascular therapy

Device is intended to treat pain associated with hypertrophic bone growth, a common contributor to lumbar spinal stenosis

New device aims to address appointment delays, technologist shortages with simplified setup

The system is intended for use by trained health care professionals and integrates into existing clinical workflows without requiring changes to treatment planning systems or IT infrastructure.

The approval allows Seimens' systems to deliver low-dose radiation therapy to patients whose osteoarthritis has not responded to other medical treatments.

Neurostimulation system offers alternative for patients who fail standard therapies

New device features corrugated design for navigating blood vessels during clot removal procedures

Expanded compatibility includes 7 Tesla scanners, enhanced communication capabilities

Virtual care assistant targets gap in outpatient recovery monitoring as same-day procedures shift clinical oversight burden

Novel knee device receives priority review and entry into the FDA’s advisory program as advances in joint preservation reshape treatment options for irreparable meniscus injuries

The agency is also opening a public comment period on what could become its most significant anti-fraud rulemaking in years, and it wants to hear from physicians.