Category: Medical Devices

April 15, 2024

US-based Sight Sciences has published the two-year post-surgical outcomes of its minimally invasive glaucoma surgery device, the OMNI surgical system. The data from the real-world clinical outcomes study was published in the American Journal of Ophthalmology. The study collected data […]

April 11, 2024

Digital healthcare is playing a transformative role in the management of diabetes by providing resources to help patients monitor their blood glucose levels, track medications, make informed decisions about their diet and exercise, and receive personalised guidance and support. One […]

April 5, 2024

Nexalin Technology has secured a US patent related to its non-invasive, frequency-based deep brain stimulation device, Gen-3 HALO Clarity system. Awarded by the United States Patent and Trademark Office (USPTO), the patent is entitled “Transcranial Alternating Current Dynamic Frequency Stimulation […]

April 2, 2024

China Medical University Hospital (CMUH) has developed a new home-based system, Intelligent Detection of Respiratory Events through Automated Monitoring (iDREAM), for detecting sleep apnoea. The device utilises AI to accurately detect severe obstructive sleep apnoea syndrome (OSAS) during sleep sessions […]

March 19, 2024

Continuous glucose monitors (CGMs) are a class of medical devices used to assist in managing both type 1 and type 2 diabetes. The market has experienced extraordinary growth in recent years and has become a rapidly evolving segment of diabetes […]

March 6, 2024

Continuous glucose monitoring plays an integral role in the management of Type 2 diabetes and the benefits are proven when used alone, or alongside other diabetes and weight management medications.8 Studies show the use of Dexcom continuous glucose monitoring by […]

February 20, 2024

Migraine affects over 1 billion people worldwide, including 10% of children and adolescents. It’s a debilitating neurological condition that can significantly impact daily life. Traditional treatment options often involve medication with potential side effects or limitations. Theranica’s Nerivio REN wearable […]

February 20, 2024

Historically, electrophysiological monitoring confined patients to clinical settings with cumbersome equipment. X-trodes’ Smart Skin disrupts this paradigm by transforming an entire monitoring lab into a discreet, flexible, and entirely wireless patch. This empowers users with continuous, medical-grade monitoring in their […]

February 19, 2024

The types of medical devices available and their use in patient care continue to accelerate. The medical devices market is anticipated to surpass $656B by 2032, and it is poised to reach a compound annual growth rate (CAGR) of 3.0% […]

February 19, 2024

Medical device company Sharps Technology is set to enhance its global distribution and sales network for drug delivery systems through new North American third-party logistics (3PL) partnerships and a strategic alliance with Roncadelle Operations. This collaboration aims to leverage the […]

February 12, 2024

Previously, only people with diabetes who required multiple daily insulin injections were eligible for Medicare coverage of implantable CGMs. This new policy removes that restriction, making the Eversense E3 accessible to all insulin users as well as non-insulin users with […]

February 9, 2024

Biotronik has launched the Micro Rx catheter, a new device for enhancing guidewire support during percutaneous coronary interventions (PCI), in the US. The rapid exchange microcatheter is produced by Interventional Medical Device Solutions (IMDS) and exclusively distributed by Biotronik. The […]

February 5, 2024

There is little to no guidance by the European Medicines Agency (EMA) regarding the advanced use of RWE such as external controls and virtual trials, said Dr Andreas Beust, CEO of German contract research organisation (CRO) GCP-Service International. The use […]

February 5, 2024

Aclinical investigation may not be mandatory for Implantable and Class III medical devices under Article 61(4)-(6) of the European Union Medical Device Regulation (EU MDR) if one of four cases apply to the device under evaluation, said John Thomas, director […]

January 19, 2024

Medical device company Calcivis is set to launch its new preventive bioluminescent dental imaging system in the US. The move comes after the company secured final-stage US Food and Drug Administration (FDA) pre-market approval (PMA) for its new ergonomic, wireless, […]

January 11, 2024

Speed is of the essence for new medical devices entering the market – and the coating plays a vital role. Delays in the commercial launch of a medical device can have a serious impact on the bottom line and impede […]

January 9, 2024

Abbott and Tandem Diabetes Care have announced the wireless integration of Abbott’s FreeStyle Libre 2 Plus continuous glucose monitor with the Tandem t:slim X2 insulin pump in the US. This announcement provides an additional treatment option for patients with diabetes […]

December 29, 2023

Boston Scientific has commenced the AVANT GUARD clinical trial of the FARAPULSE Pulsed Field Ablation (PFA) System as a first-line treatment for persistent atrial fibrillation. The first trial subject was enrolled at the Cleveland Clinic in the US. AVANT GUARD […]

December 21, 2023

Living with diabetes, Carlton “PeeWee” Gautney Jr. relied on a digital device about the size of a deck of playing cards to pump insulin into his bloodstream. The pump, manufactured by device maker Medtronic, connected plastic tubing to an insulin […]

December 18, 2023

Neuronetics has received US Food and Drug Administration (FDA) clearance for its NeuroSite Coil placement accessory, a tool that helps users with accurate coil placement. US-based Neuronetics was the first company to receive FDA approval for its transcranial magnetic stimulation […]