Device Pipeline and Approvals

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.

ProLift portfolio meets ASTM standards for safe MRI scanning, addressing growing demand for postoperative monitoring capabilities

Instanosis Inc. announced that the U.S. Food and Drug Administration has granted Breakthrough Device Designation to its Xylazine Rapid Test (Urine), a move the company says will accelerate the device's path to market.

FDA clearance allows the Netherlands-based company to bring a two-minute, chemical-free UV-C disinfection system for transesophageal echocardiography probes to the U.S. market, aiming to improve workflow efficiency and infection control.

Compact 3T scanner from Eyas Medical Imaging designed for installation inside neonatal intensive care units aims to reduce infant transport risks while delivering high-resolution diagnostic imaging.

Mobile, AI-enabled imaging platform designed to improve workflow and precision in interventional suites

System is intended to securely fixate sutures and tapes while allowing surgeons to fine-tune graft tension and maintain stability across several common ACL graft configurations, including quadriceps tendon, quadrupled semitendinosus/gracilis, and bone–patellar tendon–bone grafts.

The mOm Essential Incubator wins U.S. regulatory clearance as hospitals seek new ways to expand access to neonatal care, particularly in rural and underserved communities, while reducing the need to separate newborns from their parents.

Quantis CVP is designed to provide a noninvasive alternative that can be used at the bedside in both adult and pediatric patients.