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Tag: health


Regulatory

FDA approves Edwards’ EVOQUE for tricuspid regurgitation

February 5, 2024

Via: Medical Device Network

Edwards Lifesciences has received approval from the US Food and Drug Administration (FDA) for its EVOQUE tricuspid valve replacement system, a transcatheter therapy, for treating TR. The system has been designed for patients with symptomatic severe TR who have not […]


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 […]


News

Pharma & Influencer Marketing: Can They Coexist Ethically?

February 2, 2024

Via: HitConsultant

Influencer marketing in the pharmaceutical industry is a complex issue with reasonable arguments on multiple sides. On the one hand, leveraging individual patients’ personal experiences and narratives may help bring an authentic voice to product messaging. This could increase trust […]


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 […]


News

New CMS pilot to test payment scheme for pricey sickle cell gene therapies

January 31, 2024

Via: Healthcare Dive

The U.S. government will test whether centrally coordinating insurance coverage can help people with sickle cell disease access expensive new gene therapies for the inherited blood condition. Two such treatments were recently approved by the Food and Drug Administration after […]


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, […]


Biomarker, Innovation

US researchers initiate study to improve pancreatic cancer detection

January 30, 2024

Via: Medical Device Network

Researchers at OU Health Stephenson Cancer Center in Oklahoma, US, are initiating a study that could transform pancreatic cancer detection using MSOT imaging. This new imaging technique, combined with a specially designed contrast agent, has the potential to identify cancer […]


News

Healing the system: Advancing economic mobility and healthcare innovation through education partnerships

January 29, 2024

Via: Healthcare Dive

The future of healthcare and improved patient outcomes relies on a competent workforce and a prepared talent pipeline. Three in four employers cite challenges in hiring, and the healthcare industry is most impacted by the talent shortage. Providing high-quality healthcare […]


News

Physician Burnout and Depression Rates Decline, Medscape Report Reveals

January 26, 2024

Via: HitConsultant

The Medscape Physician Burnout & Depression Report 2024, titled “We Have Much Work to Do,” indicates that 49% of physicians now report experiencing burnout, down from 53% in 2023. Similarly, the percentage of doctors experiencing depression dropped from 23% to […]


News

Respiratory illnesses remain ‘elevated’ throughout much of country: CDC

January 26, 2024

Via: Fox News

Respiratory illnesses that include a fever plus a cough or sore throat, causing people to seek medical care in the United States, have remained elevated in the last two weeks, the Centers for Disease Control (CDC) said Friday. “This week, […]


Innovation, Patient Experience

Unlocking Patient Insights with Conversational AI in Healthcare

January 25, 2024

Via: HitConsultant

Healthcare leaders should champion human-AI collaboration by having people work with AI to validate insights and develop engagement strategies. Organizations can — and should — implement conversational AI because it allows leaders to identify actionable areas of change and protects […]


Regulatory

Senators reintroduce bill to boost telemental healthcare

January 25, 2024

Via: Healthcare Dive

The Telemental Health Care Access Act comes as a number of Medicare telehealth flexibilities that first went into effect during the COVID-19 pandemic are set to expire at the end of the year without congressional action. Lawmakers have previously shown […]


Innovation, Med Tech

Siemens’ remote scanning software receives US FDA clearance

January 24, 2024

Via: Medical Device Network

Siemens Healthineers has received US Food and Drug Administration (FDA) approval for syngo Virtual Cockpit, a software that facilitates real-time remote scanning and collaboration among healthcare professionals. The multi-vendor scanning software allows radiologic technologists to connect with various scanners including […]


EHR & EMR

How to Utilize Blockchain for Enhanced Healthcare Security in Biotech

January 24, 2024

Via: Health IT Answers

Leveraging blockchain technology to enhance health care security in the biotech sector proves to be a promising venture. If providers and IT professionals coordinate their approaches and follow the best practices for implementation and utilization, they will strengthen their defenses. […]


News

CDC Awards Truveta Real-World Data Contract to Study COVID, Maternal Health, Pediatric Care

January 23, 2024

Via: HitConsultant

Truveta will provide the CDC with access to anonymized electronic health record (EHR) data from over 100 million patients, offering a comprehensive and timely snapshot of real-world healthcare experiences. This unprecedented access will equip CDC researchers with novel insights into: […]


Biomarker, Innovation

Cognito starts biomarker substudy in Alzheimer’s device trial

January 23, 2024

Via: Medical Device Network

Cognito Therapeutics has enrolled the first patient in a biomarker substudy within its HOPE pivotal trial evaluating sensory stimulation device in Alzheimer’s disease patients. The HOPE study (NCT05637801) is assessing the efficacy of Cognitio’s GammaSense Stimulation system in subjects with […]