March 6, 2024
Via: HitConsultantContinuous 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
Via: HitConsultantMigraine 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
Via: HitConsultantHistorically, 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
Via: HitConsultantThe 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
Via: Medical Device NetworkMedical 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
Via: HitConsultantPreviously, 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
Via: Medical Device NetworkBiotronik 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
Via: Medical Device NetworkThere 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
Via: Medical Device NetworkAclinical 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
Via: Medical Device NetworkMedical 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
Via: Medical Device NetworkSpeed 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
Via: Medical Device NetworkAbbott 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
Via: Medical Device NetworkBoston 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
Via: Kaiser Health NewsLiving 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
Via: Medical Device NetworkNeuronetics 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 […]
November 29, 2023
Via: Medical Device NetworkThe first surgeries testing an implant system designed to protect injured tendons have been successfully carried out at a Florida hospital ahead of the implants US rollout. Anika Therapeutics’ Integrity implant system is described as a hyaluronic acid-based scaffold with […]
November 17, 2023
Via: Medical Device NetworkAEuropean trade association for the medical device industry has published its 2024-2029 manifesto calling for patient-centric approaches and better industry resilience in the face of pandemics. MedTech Europe has published its manifesto for the European Union’s next five-year political cycle, […]
November 14, 2023
Via: Medical Device NetworkHowever, not all innovations are equal and nor do they follow a constant upward trend. Instead, their evolution takes the form of an S-shaped curve that reflects their typical lifecycle from early emergence to accelerating adoption, before finally stabilizing and […]
November 13, 2023
Via: HitConsultantNumerous individuals grappling with conditions such as long COVID, POTS, and ME/CFS experience symptoms resulting from diminished blood flow to the brain upon assuming an upright position. Despite being theoretically recognized, substantiating this phenomenon experimentally has proven challenging until recently. […]
November 9, 2023
Via: Medical Device NetworkArtificial intelligence (AI) has increasingly been permeating many industries in the last few years, and among them is the medical devices industry. Like in many other industries, AI is particularly useful in accelerating the process of time-intensive and resource-intensive tasks, […]