Device Pipeline and Approvals

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.

Bruin Biometrics CEO Martin Burns discusses the "formulas" that guided the company through the challenges of bringing a device to market.

ArteraAI Prostate advances prostate cancer treatment with AI-driven insights, enhancing risk assessment and personalizing care for better patient outcomes.

In a wide-ranging interview, Martin Burns discusses Bruin Biometrics’ Provizio SEM Scanner, why diagnostic and prevention tech innovation is underfunded and the challenges and opportunities facing the MedTech industry.

System integrates handheld robotics, real-time ultrasound, and advanced software to help clinicians consistently and accurately place needles during procedures like organ access, biopsies, vascular access, and therapy delivery.