Medical Device & Technology

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

Canadian medical device company Vena Medical completes seven neurosurgery cases at UTMB Health following recent FDA clearance.

What exactly are the steps for getting federal approval for new devices and technology?

The deal would fold the FDA-cleared Hotwire system, and the team behind Farapulse, into J&J's expanding cardiac ablation business.

New surgical stapling device designed to improve staple line integrity across a range of tissue thicknesses in open and laparoscopic procedures

The new capital will be used to enhance its platform with “agentic AI” capabilities for commercial teams, deepen the proprietary MedTech ontology that powers its data model, and expand the platform beyond commercial functions.

Venture will combine implantable sensing tech with 3D-printed designs

Rapid Medical says its TIGERTRIEVER 25 device is designed to improve clot retrieval in difficult large vessel occlusions, as advances in mechanical thrombectomy continue to expand stroke treatment options

A researcher in wearable medical technology describes technology that’s already helping patients and has room to grow.

The company’s device, a Class II prescription product, is positioned as a non-drug treatment for postmenopausal women with osteopenia