Medical Device & Technology

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

Study will test whether non-thermal ablation can ease urinary issues without surgery

Integration streamlines clinical workflow, expanding access to comprehensive PSG diagnostics for patients outside the lab setting

Medtronic says Scientia's guidewires and catheters will strengthen its ability to support physicians across the full neurovascular procedural workflow

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.

Company says portable immunoassay system matches central lab sensitivity, eyes partnerships in oncology drug monitoring and cardiac care

New pen injector features pull-push mechanism designed to minimize dosing errors, support scalable manufacturing for pharma partners

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.

FDA advisory pathway aims to accelerate clinical and regulatory progress for Holly, an implantable continuous renal replacement system targeting end-stage kidney disease patients

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

Agreement with MinMaxMedical aims to expand navigation and robotic capabilities across shoulder, hip and knee procedures

Company cites pivotal trial data showing high acute success and reduced ICD shocks in patients with recurrent VT

Deal expands company’s vascular intervention portfolio with fully mechanical clot-removal technology for peripheral artery disease patients

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

New EBUS device aims to improve imaging, reduce procedure preparation time and lower infection risks associated with traditional balloon-based systems

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

Shockwave C2 Aero device is designed to improve deliverability, lesion crossing and repositioning during complex coronary procedures

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.

Digital health veteran to help guide AI-powered cardiac detection strategy and research efforts

Data from 30-patient study support FDA De Novo application as company highlights system performance in bariatric procedures

Battery Ventures-backed firm adds ultrasound, industrial safety and U.S. manufacturing capabilities in dealmaking push