Medical devices and imaging technology
Medical devices and imaging technology in healthcare comprise an array of instruments from simple tools to complex machinery for diagnosing, treating and monitoring diseases. Combining engineering, physics and computer science, medical devices and imaging technologies have become essential to enhancing the accuracy of diagnoses and the effectiveness of treatments.
Top Stories
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16 Oct 2024
Exploring emerging breast cancer screening tools, technology
New breast cancer screening tools, ranging from 3D mammography to AI-assisted screening analysis play a critical role in the evolving breast cancer screening landscape. Continue Reading
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08 Oct 2024
FDA authorizes combined at-home flu, COVID-19 tests outside EUA
The Healgen Rapid Check COVID-19/Flu A&B Antigen Test is the first combined at-home flu and COVID tests to be authorized by the FDA through traditional premarket review. Continue Reading
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04 Oct 2024
WHO clears in vitro diagnostic mpox testing for emergency use
After declaring a global health emergency for mpox, the WHO has issued an Emergency Use Listing for an in vitro diagnostic test for early mpox diagnosis and treatment. Continue Reading
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26 Sep 2024
Understanding regulatory pathways for medical devices
Medical device regulation ranges from discovery to post-market regulation; however, the regulatory pathways for medical devices depend on classification. Continue Reading
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19 Aug 2024
FDA clears SleepioRx digital therapeutic for insomnia treatment
Big Health’s SleepioRx received FDA clearance. It is a digital cognitive behavioral therapy solution for chronic insomnia in adults that supports scalable access. Continue Reading
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13 Aug 2024
Breas Medical addresses formaldehyde in ventilators
Breas Medical initiates a nationwide correction to address potential formaldehyde exposure from Vivo 45 LS ventilators. Continue Reading
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06 Aug 2024
Initial cancer screening costs $43 billion annually in the US
The estimated cost of initial breast, cervical, colorectal, lung, and prostate cancer screenings across the US is $43 billion. Continue Reading
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29 Jul 2024
Exploring AI applications in radiology
Artificial intelligence can play many roles in radiology, including image analysis, interpretation, disease detection, and more. Continue Reading
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11 Jul 2024
Researchers discover toxic metals, contaminants in tampons
A study from the University of California Berkley revealed high levels of toxic metals, including arsenic, lead, and cadmium, in tampons. Continue Reading
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27 Jun 2024
FDA clears Clarius OB AI, a handheld ultrasound tool
The device is a fetal biometric measurement tool that should assist in prenatal monitoring in resource-poor communities. Continue Reading
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21 Jun 2024
FDA clears Roche’s digital pathology solution for diagnostics
The solution includes the VENTANA DP 200 slide scanner, a digital pathology workflow software, and a display for clinical diagnostics. Continue Reading
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12 Jun 2024
Women are underrepresented in medical device clinical trials
A research letter published in JAMA Internal Medicine found that medical device clinical trials had a median female participant rate of 33%. Continue Reading
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06 Jun 2024
Balancing innovation, safety, compliance, risk in life sciences
Because the life sciences sector is evolving rapidly, collaboration, compliance, and proactive risk management are key to patient safety. Continue Reading
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06 May 2024
Philips agrees to $1.1 billion settlement following CPAP recalls
A first-quarter report from Philips revealed that the company would pay $1.1 billion in litigation settlements from the Respironics class action lawsuits. Continue Reading
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02 May 2024
CDRH reports highlight progress in medical device safety, innovation
The Center for Devices and Radiological Health’s recent reports highlight significant advancements in medical device safety, innovation, and regulatory oversight. Continue Reading
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25 Apr 2024
Ultrahuman launches US-based wearable ring manufacturing facility
The company’s press release declared that this is the first time wearable rings will be manufactured domestically. Continue Reading
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23 Apr 2024
Improving mammography utilization to cut breast cancer mortality
According to a CDC report, mammography utilization decreases with adverse social determinants of health. Continue Reading
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15 Apr 2024
Exploring digital stethoscope technology for improved diagnostics
Digital stethoscopes enhance diagnostics by precisely amplifying and analyzing cardiopulmonary sounds, leading to earlier detection and improved patient outcomes. Continue Reading
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08 Apr 2024
Assessing the impacts of noncontinuous digital diabetes solutions
Peterson Health Tech Institute's report assesses noncontinuous digital diabetes management solutions and their clinical and economic impacts. Continue Reading
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04 Apr 2024
Deloitte report unveils $5–7 billion AI life sciences opportunity
In the life sciences industry, transformative value can be realized by harnessing the power of AI in research, manufacturing, and commercial functions. Continue Reading
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02 Apr 2024
FDA approves Eko Health’s Low EF detection AI for detecting heart failure
Eko Health's FDA-approved AI, developed with Mayo Clinic, aids in accurately detecting heart failure during standard exams, benefiting at-risk patients. Continue Reading
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01 Apr 2024
Understanding litigation against drug, medical device manufacturers
Understanding the surge in litigation against drug and medical device manufacturers is crucial for navigating legal complexities and ensuring patient safety. Continue Reading
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26 Mar 2024
FDA-approved insulin pumps used for insulin pump therapy
FDA-approved insulin pumps offer precise insulin pump therapy, revolutionizing diabetes management with personalized care. Continue Reading
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20 Mar 2024
Enhancing diabetes management with innovative insulin pump technology
Innovative insulin pumps have revolutionized diabetes care by offering precise control, enhancing patient outcomes, and advancing healthcare technology. Continue Reading
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08 Mar 2024
Former medical device CEO convicted for medical device fraud
After an 11-day trial, a jury in the Southern District of New York convicted Laura Perryman of healthcare fraud. Continue Reading
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07 Mar 2024
FDA Approves Over-the-Counter Sale of Dexcom CGM
For the first time in the United States, patients can get continuous glucose monitors without a prescription. Continue Reading
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04 Mar 2024
Automating Blood Glucose Monitoring Through New Technology
A new automated blood glucose monitor cuts down on the manual steps many people with diabetes take to check and manage their sugar daily. Continue Reading
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26 Feb 2024
Exploring 5 Healthcare Imaging Techniques: Uses and Limitations
Advanced imaging techniques play a critical role across healthcare, with a hand in diagnostics and disease monitoring. Continue Reading
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07 Feb 2024
Revolutionizing Diabetes Care with Advanced CGM Devices
Advanced continuous glucose monitoring (CGM) devices offer real-time glucose readings, eliminating frequent finger stick testing to monitor blood sugar levels. Continue Reading
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31 Jan 2024
Revolutionizing Fertility Treatment with a MicroICSI Device
As an alternative to traditional in vitro fertilization, a new microICSI device is poised to streamline fertility treatments and revolutionize patient care. Continue Reading
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22 Jan 2024
Understanding the Risks Associated with BiPAP, CPAP Recalls
With many patients globally using BiPAP and CPAP machines to manage sleep apnea, it is critical to understand how the recalls impact the patients using them. Continue Reading
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11 Jan 2024
FDA Updates Medical Device Sterility Guidelines
The FDA released a final guidance for medical devices that are labeled as sterile, identifying vaporized hydrogen peroxide as an effective sterilization method. Continue Reading
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20 Dec 2023
FDA Issues Draft Guidance for Using RWD in Medical Device Regulation
The guidance outlines multiple factors of RWD, including appropriate use, data relevance and reliability, data collection and analysis, and documentation. Continue Reading
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19 Dec 2023
Minimizing the Impact of Bias in Healthcare Algorithms
A special communication in JAMA Network Open outlines strategies for minimizing racial and ethnic bias impacts in healthcare algorithms. Continue Reading
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18 Dec 2023
Exploring the Benefits of Digital Pathology Platforms and Sharing
LifeSciencesIntelligence explores the implications of digital pathology integration and the benefits of data sharing in pathology. Continue Reading
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08 Dec 2023
Ophthalmic Scans Provide Insight into Kidney Health
Researchers identify that choroidal and retinal thinning detected in ophthalmic scans may be biomarkers for chronic kidney diseases. Continue Reading
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07 Dec 2023
Ultrasound Technology May Provide a New Vaccine Delivery Method
Researchers at the University of Oxford explore using ultrasound technology for needle-free vaccine delivery. Continue Reading
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06 Dec 2023
Predicting Next Year’s Life Sciences Outlook: Med Devices, Biopharma
Deloitte’s 2024 Life Sciences Outlooks predicts medical device and biopharma trends, focusing on digital transformation, GenAI, and adopting digital health tools. Continue Reading
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29 Nov 2023
AMA Publishes Guidance on AI Development, Deployment, Use
The guidance prioritizes ethical, equitable, responsible, and transparent AI integration despite limited governance. Continue Reading
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28 Nov 2023
Analyzing Data in the Medical Device Marketing Landscape
Understanding how to analyze and leverage data for medical device marketing is critical to product launch success. Continue Reading
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27 Nov 2023
AstraZeneca Launches Evinova to Advance Digital Health Solutions
AstraZeneca's launches Evinova to advance innovation in life sciences, delivering advanced digital health solutions for improved outcomes. Continue Reading
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20 Nov 2023
Embracing AI in Life Sciences: Opportunities for Healthcare Technology
Embracing AI in life sciences is crucial for unlocking opportunities and advancing healthcare technology. Continue Reading
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14 Nov 2023
Advancements in Pancreatic Cancer Screenings
In honor of pancreatic cancer awareness month, LifeSciencesIntelligence explores recent advancements in pancreatic cancer screenings. Continue Reading
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13 Nov 2023
Improving Diabetes Care for Native Americans with Healthcare Technology
Improving diabetes care for Native Americans through healthcare technology is vital for equitable and personalized management. Continue Reading
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09 Nov 2023
Johnson and Johnson Reveals General Surgery Robot Timeline
The company anticipates submitting the OTTAVA system to the FDA in 2024 to begin clinical trials. Continue Reading
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06 Nov 2023
How CGM Technology Is Transforming Diabetes Management
Understanding CGM technology in diabetes management helps patients monitor blood sugar levels in real time, improving control and reducing complications. Continue Reading
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30 Oct 2023
Exploring Digital Transformations in Life Sciences, Biomedical Affairs
Exploring digital transformations in life sciences is vital for accelerating drug discovery, improving patient care, and advancing healthcare innovation. Continue Reading
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26 Oct 2023
DeNovix CellDrop: The First ACT Label Certified Automated Cell Counter
DeNovix CellDrop's ACT Label certification signifies eco-conscious innovation, reducing plastic waste, and sustainability in healthcare technology. Continue Reading
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23 Oct 2023
Exploring the Role of Healthcare Providers in CGM Coaching, Education
Continuous glucose monitoring (CGM) coaching and education are crucial as they empower patients to make informed decisions. Continue Reading
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16 Oct 2023
5 Critical Steps for Entering the Life Sciences Market
As new technologies and advancements continue to add to the life sciences space, companies must have a comprehensive understanding of entering the life sciences market. Continue Reading
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13 Oct 2023
FDA Launches Advisory Committee for Digital Health Technologies
The FDA’s newest Digital Health Advisory Committee will explore AI/ML, AR, VR, digital therapeutics, wearables, remote patient monitoring, and more. Continue Reading
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11 Oct 2023
FDA Issues Update on the Philips BiPAP and CPAP Recalls
A statement attributed to Jeff Shuren, MD, JD, director of the FDA Center for Devices and Radiological Health, was issued on October 5, 2023. Continue Reading
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02 Oct 2023
Essential Factors for Launching New Medical Imaging Technology
As Exo launches Iris, its newest medical imaging device, Sandeep Akkaraju provided insights into the factors contributing to a medical technology launch. Continue Reading
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25 Sep 2023
COVIDTests.gov Reopens for Americans to Request At-Home COVID Test
The Biden administration has allocated $600 million to manufacture new at-home COVID-19 tests and reopen the site. Continue Reading
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21 Sep 2023
Researchers Identify Depression Recovery Biomarkers Using DBS Device
Alongside AI technology, researchers believe a novel DBS device can detect recovery biomarkers from treatment-resistant depression. Continue Reading
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15 Sep 2023
FDA Issues Three New Draft Guidance Documents for Medical Devices
The guidance is intended to modernize the 510(k) Program, improving medical device effectiveness and safety. Continue Reading
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11 Sep 2023
Digital Assays Detect Nucleic Acids to Identify Clinical Pathogens
Karolinska Institute researchers developed a novel tool for clinical pathogen detection using DNA nanoballs. Continue Reading
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22 Aug 2023
Why This Dual Chamber Auto-Injector Won Three Design Awards
The auto-injector is a dual-chamber, automatic, reusable device for pediatric patients with growth hormone deficiency. Continue Reading
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04 Aug 2023
Stryker’s New Automated Image-Guided Therapy Tool Propels Sector Competition
Medical device manufacturers are expanding their image-guided platforms to include state-of-the-art capabilities. Continue Reading
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03 Aug 2023
Exploring the 5 FDA-Approved IUDs: Types, Benefits, and Effectiveness
IUDs are a primary tool to control reproduction, benefit public health, empower individuals, and enhance healthcare outcomes. Continue Reading
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27 Jul 2023
Comparing Stryker and Medtronic’s 2022 ESG Ratings
Two of the top medical device manufacturers have a similar track record and several ethics concerns. Continue Reading
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13 Jul 2023
FDA Recalls Several J&J Medical Devices After Reports of Burn Injuries
Before being recalled, the electrosurgery tools were potentially involved in more than 60 patient injuries. Continue Reading
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06 Jul 2023
Deep Learning Model Accurately Predicts Mortality in Pneumonia Patients
A new artificial intelligence model may soon help radiologists create prognoses for patients with pneumonia. Continue Reading
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29 Jun 2023
Startups Cash in on Artificial Intelligence for Medical Imaging as Industry Shifts
Healthcare giants and fledgling outfits are all capitalizing on the artificial intelligence frenzy sweeping radiology. Continue Reading
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16 Jun 2023
Exploring Biofilms on Medical Devices and Intervention Strategies
Research sheds light on a hidden threat to the healthcare community and patients: biofilms. Continue Reading
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09 Jun 2023
GE Healthcare Reveals Pioneering Artificial Intelligence Tool for Faster MRI
Their AI-based medical imaging tool can take a cardiac image 12 times faster than previously possible. Continue Reading
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25 May 2023
NIH-Funded Nature Study Identifies Biomarkers for Chronic Pain
In a Nature Neuroscience study funded by the NIH, researchers identified biomarkers for chronic pain using surgically implanted electrodes. Continue Reading
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18 May 2023
Infectious Disease Specialists Recommend Masking Despite PHE Ending
Masks are likely to remain in many hospitals and health systems as the COVID-19 public health emergency ends. Continue Reading
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25 Apr 2023
Understanding the FDA Medical Device Cybersecurity Protocols
As the FDA incorporates its new medical device cybersecurity protocols and plans for strict enforcement in October 2023, it is critical to understand guidance components and their legal implications. Continue Reading
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20 Apr 2023
Exploring Applications of Augmented and Mixed Reality in Healthcare
Cutting-edge augmented and mixed reality (AR/MR) is transforming the healthcare industry with innovative applications that unprecedentedly improve patient outcomes. Continue Reading
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19 Apr 2023
Duke Medical Imaging Research Creates 64 Million Times Sharper MRI Image
The novel medical imaging technique could alter the study of neurodegeneration in humans. Continue Reading
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17 Apr 2023
OTC Hearing Aids Are as Effective as Prescription Hearing Aids
A new study published in JAMA by researchers at the University of Colorado found that over-the-counter (OTC) hearing aids are as effective as prescription aids in managing mild-to-moderate hearing loss. Continue Reading
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11 Apr 2023
FDA Identifies Class I Recall on Philips CPAP and BiPAP Machines
After a recall of the masks used for the Philips Respironics CPAP and BiPAP Machines in 2022, the FDA has identified a Class I recall on the devices. Continue Reading
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28 Mar 2023
Researchers Test Harm Reduction Tool Xylazine Test Strips
Researchers at the Center for Forensic Science Research and Education tested xylazine test strips, which may be a critical harm reduction tool for opioid users. Continue Reading
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13 Mar 2023
Exploring Traditional, Experimental Screenings for Colorectal Cancer
Considering the rising rates of colorectal cancer, clinicians are looking at traditional and experimental screening tools for detecting the condition. Continue Reading
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10 Mar 2023
FDA Requires Breast Density Information, New Mammography Regulations
The FDA issued new mammography regulations, requiring facilities to share information on breast density with patients and enhance facility oversight. Continue Reading
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09 Mar 2023
Researchers Find Gadolinium Used in Medical Imaging Stays in Kidneys
A University of New Mexico study found that gadolinium-based contrast agents sometimes remain in the body, causing severe disease. Continue Reading
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01 Mar 2023
FDA Issues Emergency Use Authorization for COVID and Influenza Tests
The FDA recently issued an emergency use authorization for over-the-counter at-home tests that can detect influenza and COVID. Continue Reading
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16 Feb 2023
Globus Medical and NuVasive Agree to $3.1B Merger
Two US medical device companies, Globus Medical and NuVasive, will leverage their portfolios to create a global musculoskeletal powerhouse. Continue Reading
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13 Feb 2023
Standardizing Measurements of Sleep, Discrepancies Among Digital Tools
Despite the importance of sleep and the multitude of digital tools intended to measure its quality, there are many discrepancies among sleep measurements, indicating a need for more standardization. Continue Reading
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09 Feb 2023
Bayer Brings British AI Radiology Firm, Blackford Analysis, Onboard
Bayer will boost its radiology business by adding Blackford’s artificial intelligence tools for analyzing medical images. Continue Reading
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08 Feb 2023
Understanding the Correlation Between Hearing Loss and Dementia
In a research letter for JAMA Network, investigators looked at the correlation between hearing loss and dementia, analyzing whether hearing aids could be an effective prevention tool. Continue Reading
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03 Feb 2023
Researchers Develop a Model to Predict Lung Cancer Risk Using CT Scans
A publication in the Journal of Clinical Oncology detailed a model developed by researchers to predict lung cancer risk using a low-dose chest CT scan. Continue Reading
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24 Jan 2023
ECRI Highlights Communication Gaps in Medical Device Recalls
The ECRI recently highlighted communication gaps in medical device recalls in its Top 10 Health Technology Hazards report, which may result in potential patient safety risks. Continue Reading
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19 Jan 2023
GE Healthcare to Acquire IMACTIS for CT Interventional Guidance
The freshly spun-off GE HealthCare announced its first acquisition, snatching up the French CT navigation system developer IMACTIS. Continue Reading
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18 Jan 2023
MRI-Guided Radiotherapy Improves Prostate Cancer Outcomes, Comparison
A recent publication in JAMA Oncology determined that MRI-guided radiotherapy improved prostate cancer outcomes compared to CT-guided radiotherapy. Continue Reading
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19 Dec 2022
How Virtual Reality Could Reform Surgical Training
The use of virtual reality technology in surgical training could prepare doctors globally for complex situations, decrease surgical complications, and improve patient outcomes. Continue Reading
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16 Dec 2022
Examining the Relationship Between CT Scans and Brain Cancer
A recent study published in the Lancet Oncology examined the relationship between radiation exposure from CT scans and brain cancer in children and young adults. Continue Reading
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12 Dec 2022
Applying Augmented and Virtual Reality in Healthcare
The rise of augmented and virtual reality has led to many healthcare applications, presenting new treatment options and widening accessibility. Continue Reading
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07 Dec 2022
Maternal Anemia Alters Structural Development of Child’s Brain
In an analysis of 147 mother–child pairs in South Africa, researchers found that maternal anemia alters the structural development of the child’s brain. Continue Reading
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06 Dec 2022
Applications of 3D Printing, Enhancing Precision Medicine
Applications of 3D printing in medicine have expanded since its start in the 1980s, enhancing precision medicine, addressing supply chain issues, and expanding educational opportunities. Continue Reading
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30 Nov 2022
Lung Cancer Screening Improves Long-Term Survival Rate
The Radiological Society of North America announced the results of a 20-year international study that determined lung cancer screening improves long-term survival rates. Continue Reading
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28 Nov 2022
Exploring Non-Pharmacological Interventions for Epilepsy
With 50 million people worldwide struggling with epilepsy, understanding treatment options, including non-pharmacological interventions, is essential for delivering effective symptom relief. Continue Reading
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23 Nov 2022
Blu Biotech to Collaborate on Sepsis Detection Device
In a press release on November 15, 2022, Blu Biotech announced its plans to collaborate with the University of Michigan to develop breath biomarkers for detecting sepsis and acute respiratory distress syndrome to be used with its Micro GC device. Continue Reading
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22 Nov 2022
Epidural Electrical Stimulation Can Restore Walking
In a recent study published in Nature, researchers found that epidural electrical stimulation of the lumbar spinal cord can restore walking in those paralyzed from spinal cord injuries. Continue Reading
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16 Nov 2022
New Commercially Available PCR Test Detects 3 Brain-Eating Amoebas in 3 Hours
A new commercially available PCR test can detect three common brain-eating amoebas in three hours: Naegleria fowleri, Balamuthia mandrilaris, and Acanthamoeba spp. Continue Reading
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16 Nov 2022
Lilly Rolls Out Personalized Diabetes Management Platform
In a recent press release, Lilly announced that it plans to roll out its personalized diabetes management platform to help patients and providers make informed, data-backed clinical decisions. Continue Reading
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14 Nov 2022
Digitizing the Diagnostic Pathway for Dementia
Digitizing portions of the diagnostic pathway for dementia may help reduce diagnostic barriers and alleviate burdens on providers. Continue Reading
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09 Nov 2022
80% of Patients on Dialysis Struggle to Manage Serum Phosphorous Levels
In a survey conducted by Ardelyx and the National Kidney Foundation, approximately 80% of patients on dialysis reported trouble managing serum phosphorous levels. Continue Reading
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07 Nov 2022
Comparing the Accuracy of Transvaginal Ultrasound and MRI
In a recent publication, researchers compared the accuracy of transvaginal ultrasound and MRI in detecting endometrial cancer. Continue Reading
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03 Nov 2022
Medical Imaging Study Shows Long-Term Implications of COVID-19 Infection
A small study using new low-wave MRI technology showed persistent pulmonary dysfunction in people infected with COVID-19. Continue Reading
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01 Nov 2022
How Wireless-Guided Localization and Precision Surgery Is Changing Breast Cancer Treatment
Precision surgery techniques such as wireless-guided localization are changing how patients and providers experience breast cancer treatment and removal. Continue Reading