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Category: Medical Devices


Innovation, Medical Devices

Dexcom Earns FDA Clearance for OTC Glucose Biosensor in the U.S.

March 6, 2024

Via: HitConsultant

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 […]


Innovation, Medical Devices

Highmark Grants Commercial Coverage to Theranica’s Wearable for Migraine Treatment

February 20, 2024

Via: HitConsultant

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 […]


Innovation, Medical Devices

X-trodes’ Smart Skin Earns FDA Clearance for Home-Based Electrophysiological Monitoring

February 20, 2024

Via: HitConsultant

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 […]


Innovation, Medical Devices

Unlocking Medical Device Potential: Data Integration Drives Better Patient Outcomes

February 19, 2024

Via: HitConsultant

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% […]


Innovation, Medical Devices

Sharps Technology to partner for drug delivery systems

February 19, 2024

Via: Medical Device Network

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 […]


Innovation, Medical Devices

Medicare Expands Coverage for Eversense E3 CGM System, Offering More Options for Diabetes Management

February 12, 2024

Via: HitConsultant

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 […]


Innovation, Medical Devices

Biotronik launches Micro Rx catheter in US

February 9, 2024

Via: Medical Device Network

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 […]


Innovation, Medical Devices

More guidance needed to use RWE to support device approvals in EU

February 5, 2024

Via: Medical Device Network

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 […]


Innovation, Medical Devices

High risk devices can be exempted from mandatory trials under EU MDR

February 5, 2024

Via: Medical Device Network

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 […]


Innovation, Medical Devices

Calcivis to introduce preventive dental technology in US

January 19, 2024

Via: Medical Device Network

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, […]


Innovation, Medical Devices

The need for speed: Faster medical device timelines with the right coating

January 11, 2024

Via: Medical Device Network

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 […]


Innovation, Medical Devices

Abbott and Tandem provide new option for diabetes management

January 9, 2024

Via: Medical Device Network

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 […]


Innovation, Medical Devices

Boston Scientific begins trial of persistent atrial fibrillation system

December 29, 2023

Via: Medical Device Network

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 […]


Innovation, Medical Devices

Deep Flaws in FDA Oversight of Medical Devices, and Patient Harm, Exposed in Lawsuits and Records

December 21, 2023

Via: Kaiser Health News

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 […]


Innovation, Medical Devices

Neuronetics lands FDA clearance for TMS therapy accessory

December 18, 2023

Via: Medical Device Network

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 […]


Innovation, Medical Devices

First surgeries testing rotator cuff augmentation implant carried out in Florida

November 29, 2023

Via: Medical Device Network

The 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 […]


Innovation, Medical Devices

New MedTech Europe manifesto calls for stronger systems across Europe

November 17, 2023

Via: Medical Device Network

AEuropean 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, […]


Innovation, Medical Devices

Leading innovators in ultrasonic nebulizers for the medical devices industry

November 14, 2023

Via: Medical Device Network

However, 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 […]


Innovation, Medical Devices

In-Ear Wearable Measures Blood Flow to the Head for Long COVID POTS

November 13, 2023

Via: HitConsultant

Numerous 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. […]


Innovation, Medical Devices

Artificial intelligence in the medical devices industry set for rapid growth

November 9, 2023

Via: Medical Device Network

Artificial 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, […]