Device Pipeline and Approvals

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.

System is designed to provide fully automated, near real-time ECG interpretation at enterprise scale.

Edwards Lifesciences device expands options for patients with severe mitral regurgitation who are not candidates for surgery

Shape Memory Medical's IMPEDE Embolization Plug gains Class III certification in Europe, enhancing access and confidence in advanced endovascular therapies.

SleepRes is introducing the Kricket PAP device, which achieved FDA clearance and is a solution for sleep apnea that enhances comfort and adherence through adaptive pressure technology.

Device addresses PCOS-related infertility for those who do not respond to standard drug therapies

BlueWind Medical's Revi wearable for urinary incontinence offers effective, user-friendly therapy that boosts patient satisfaction and long-term relief.

Nephrodite's Holly system advances kidney care with an implantable continuous dialysis solution, enhancing patient freedom and quality of life.

Flow Neuroscience's FDA-approved device offers an at-home treatment for depression, providing a non-drug option with proven effectiveness and minimal side effects.

Bendit Technologies launches the Bendit17 Microcatheter, enhancing precision in vascular procedures with FDA clearance for U.S. market entry.

Blood-based diagnostic aims to reduce unnecessary prostate biopsies and improve cancer risk assessment.

GE Healthcare launches Pristina Recon DL, a new AI-driven mammography technology enhancing image quality and supporting early breast cancer detection.

Transmural Systems launches TELLTALE, an innovative electrosurgical guidewire, enhancing safety in transcatheter aortic valve replacement procedures.

Dexcom Smart Basal optimizes insulin dosing for Type 2 diabetes, integrating CGM data for personalized recommendations and enhancing patient care efficiency.