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Category: Innovation


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, Research

Stress during pregnancy can lead to early maturation of first-born daughters

February 20, 2024

Via: ScienceDaily

The study was the first to identify earlier patterns of adrenal puberty as a result of prenatal stress. Adrenal puberty is marked by changes like the growth of body hair, pimples and aspects of cognitive maturation, but does not include […]


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, Med Tech

Clarius Mobile Health unveils T-Mode AI technology for clinicians

February 16, 2024

Via: Medical Device Network

Clarius Mobile Health has launched T-Mode AI, a new educational tool designed to improve clinicians’ ultrasound image interpretation skills with the help of handheld scanners. Utilising artificial intelligence (AI), T-Mode AI transforms grayscale ultrasound images by adding colour, patterns and […]


Innovation, Med Tech

How Open-Source Technologies Will Transform Digital Clinical Trials

February 14, 2024

Via: HitConsultant

Although the traditional nearly decade-long clinical trial timelines completely collapsed during COVID, this truncating was not necessarily novel. Precedent exists for accelerating approval timelines during health emergencies such as the AIDs/HIV epidemic, where Compound S, a re-make of AZT, or […]


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, Research

Study finds that proteins may predict who will get dementia in 10 years based on blood samples

February 12, 2024

Via: Fox News

A study of frozen blood samples has turned up a trove of proteins that may predict several forms of dementia more than 10 years before the disease is diagnosed, researchers from the U.K. and China reported on Monday. The study, […]


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, Med Tech

Healthcare app regulators are adapting to increased activity

February 8, 2024

Via: Medical Device Network

Two very distinct types of apps focus on healthcare: the nebulous wellness category and regulated digital therapeutics. This divide is due to national regulatory bodies such as the US Food and Drug Administration (FDA) that oversee the approval of apps […]


Innovation, Patient Experience

Five ways disconnected consent is impacting patient experiences

February 7, 2024

Via: Medical Device Network

One critical aspect of patient-provider interactions that often goes overlooked is consent. When consent management processes are disconnected or poorly managed, it can have a detrimental impact on patient experiences. With many healthcare providers managing multiple tech stacks across siloed […]


Innovation, Med Tech

2024: The Year of Smarter Automation and AI in Healthcare Revenue Cycle

February 6, 2024

Via: HitConsultant

Some may be fatigued by it, or even afraid of it, but the reality is AI is here to stay in 2024. The best thing we can all do is learn how to leverage it to make our jobs easier. […]


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 […]


Biomarker, Innovation

FDA grants clearance for Hologic’s cervical cancer screening system

February 2, 2024

Via: Medical Device Network

The US Food and Drug Administration (FDA) has granted clearance for Hologic’s new Genius Digital Diagnostics System with the Genius Cervical AI algorithm for cervical cancer screening. This system is claimed to be the first FDA-cleared digital cytology platform that […]


Innovation, Research

Alzheimer’s disease found to be transmitted through medical procedures decades ago, study finds

February 1, 2024

Via: Fox News

Alzheimer’s disease has been considered something that happens from within, generally speaking — but for the first time, researchers have identified cases that were triggered by a specific medical treatment. The most common type of dementia, Alzheimer’s is caused by […]


Innovation, Med Tech

FDA extends deadline for comments on role of digital health in diabetes detection

February 1, 2024

Via: Healthcare Dive

The FDA believes the healthcare sector is yet to realize the full potential of DHTs in the detection of diabetes, “especially in diverse populations, particularly racial and ethnic minorities.” The agency sees the technologies as an enabler of the focus […]


Innovation, Research

PathAI Expands PathExplore Reach to 14 Cancer Types, Fueling Precision Oncology

January 31, 2024

Via: HitConsultant

Despite advances in cancer treatment, many patients remain unresponsive to available therapies or lack access to potentially life-saving options due to the absence of actionable biomarkers. The TME, a complex ecosystem of cells and tissues surrounding the tumor, holds immense […]


Innovation, Research

Kids who consume energy drinks are more prone to mental health disorders, study finds

January 31, 2024

Via: Fox News

Energy drinks could pose a risk to young brains, according to new research. Those who consumed energy drinks — which are intended to boost energy through the use of caffeine or other stimulants — were shown to have a higher […]


Innovation, Med Tech

Swift Medical Secures $8M to Power AI-Driven Wound Care

January 30, 2024

Via: HitConsultant

Swift Medical boasts a proven track record, serving as the trusted wound care partner for over 4,000 healthcare facilities across North America. Their platform empowers over 20,000 clinical users to deliver standardized, accessible, and equitable care to patients through: Advanced, […]