Device Pipeline and Approvals

FDA 510(k) clearance for its Hemastyl gel device marks the first technology that has treated the tissue surrounding chronic wounds and prevented numerous amputations.

Hubly Surgical's FDA-cleared auto-stop drill enhances spinal surgery safety, preventing injury with innovative technology for precise, efficient procedures.

Augmedics unveiled the X2 augmented reality surgical headset, which enhances precision and comfort in spinal surgeries with advanced imaging and ergonomic design.

ZAP Surgical's new Axon system advances brain radiosurgery with FDA and CE approvals, enhancing precision and efficiency in treatment planning.

UroViu's CE-certified portable endoscopy device offer procedures with wireless connectivity, enhancing efficiency and patient care in urology and urogynecology.

Sirona Medical launches its FDA-cleared Advanced Imaging Suite, boosting radiology with cloud-native PET-CT capabilities for enhanced diagnostic flexibility.

GeneDx's genomic tests gain FDA Breakthrough Device Designation, enhancing diagnosis of life-threatening diseases through advanced whole genome and exome testing.

OcuMet Beacon enhances early detection and management of retinal diseases

New CMS reimbursement code supports wider hospital adoption of Pleural Dynamics’ fully implantable ACES device for chronic pleural effusion treatment.

Asahi Kasei unveils the ZOLL Zenix defibrillator, enhancing emergency care with advanced technology and real-time guidance for health care professionals.

AngioSafe's Santreva-ATK catheter advances endovascular treatment for chronic total occlusions, enhancing patient care with innovative, wire-free technology.

Neural Sleeve 2 uses AI-driven MultiStim technology for muscle activation and spasm relaxation, aiding conditions like multiple sclerosis and stroke.

Medtronic's Altaviva device advances urinary incontinence treatment with its minimally invasive tibial neuromodulation technology.

Ruthless Spine gains FDA clearance for its NavJam device, advancing spinal navigation with cost-effective, portable solutions for accurate screw placement.

Imperative Care's Symphony Thrombectomy System gains FDA clearance, advancing pulmonary embolism treatment with enhanced control and faster recovery options.

Glucose biosensor combined with artificial intelligence-powered platform provides real-time insights into how food, exercise, stress, and sleep affect the body.

Masimo's O3 Regional Oximetry gains FDA clearance, enhancing tissue oxygen monitoring for improved patient care in critical settings.

ArteraAI Prostate advances prostate cancer care with FDA authorization, offering AI-driven insights for personalized treatment and improved diagnostic efficiency.

Cardiosense's CardioTag gains FDA clearance, advancing cardiac monitoring with wearable technology for personalized, noninvasive heart health insights.

Takeda introduces HyHub and HyHub Duo, innovative devices simplifying at-home administration of HYQVIA, enhancing patient experience in immune therapy.

Caranx Medical's AI software advances TAVI procedures, enhancing precision and accessibility for heart valve surgeries, improving patient outcomes.