Medical Device & Technology

The Thermocool Smarttouch SF Platform now lets electrophysiologists deliver radiofrequency or pulsed field energy through a single catheter integrated with the Carto mapping system.

The 510(k) clearance for the LARS ACJ implant marks the U.S. debut of a synthetic ligament platform already used in more than 250,000 patients worldwide over three decades.

The Swiss spine technology company says the system requires no capital investment and can be prepared in under two minutes, aiming to remove longstanding operational barriers to broader adoption of minimally invasive spine procedures.

Tandem Diabetes Care expands its Control-IQ+ automated insulin delivery system to work with Abbott's newest 15-day continuous glucose monitor across the United Kingdom, Switzerland, Sweden, Finland and Italy, with Belgium, the Netherlands and Germany slated to follow later this year.

Clearance is backed by a 159-patient, 10-site study showing higher response rates than physical therapy alone

The premarket approval of United Therapeutics' LungFX device lets transplant programs outsource lung re-evaluation to dedicated facilities rather than building in-house EVLP capacity.

FDA clears Life Spine's VersaLift expandable interbody system, featuring a 6mm starting height for constrained anatomy

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