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Lessons from the Pandemic: Mitigating Product Liability Risk in Supply Chains
Designing Medical Devices for the Human Touch
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Linus Health Acquires Together Senior Health
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KORU Medical Systems Announces Leadership Changes
Abbott Issues Voluntary Medical Device Correction for Small Number of Freestyle Libre 3 Sensors
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Lessons from the Pandemic: Mitigating Product Liability Risk in Supply Chains
Designing Medical Devices for the Human Touch
Special Delivery for Drug-Device Combination Products
Clean Conditions: A Roundtable on Medical Device Packaging & Sterilization
Medical Molders Are Specialized Sculptors
Top 30 Medical Device Companies
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UKCA Marking for Medical Devices: Addressing Commonly Asked Questions
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Diagnostics
Diagnostics
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Cardiovascular
Chronic Disease
Diagnostics
Digital Health
Neurological
Patient Monitoring
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Diagnostics
FDA Grants bioMérieux Special 510(k) Clearance and CLIA-waiver for New BIOFIRE SPOTFIRE Panel
This Respiratory/Sore Throat (R/ST) Panel Mini is the fourth panel in the BIOFIRE SPOTFIRE range.
Rachel Klemovitch, Assistant Editor
07.25.24
Diagnostics
bioMérieux Gains US FDA 510(k) Clearance for VITEK REVEAL AST System
The VITEK REVEAL AST System results come directly from positive blood cultures.
Rachel Klemovitch, Assistant Editor
07.25.24
Diagnostics
Microstructure Imaging Gains FDA Clearance for MICSI-RMT
MICSI-RMT is a software suite, designed to enhance MRI image quality.
Rachel Klemovitch, Assistant Editor
07.25.24
Diagnostics
|
Digital Health
Study: AI-Enhanced MRI Selection Method Enhances Breast Cancer Detection
A newly developed AI technology can accurately assess mammogram images and identify women at high risk for missed cancer.
Michael Barbella, Managing Editor
07.24.24
Diagnostics
|
Software & IT
Precision Diagnostics Save Lives, Optimize Workforce, and Boost Efficiency
Leveraging AI and machine learning tools can enhance a facility’s productivity and precision.
Pravin Vazirani, Assistant Vice President of Operations, Chetu
07.24.24
Chronic Disease
|
Diagnostics
Guardant Health Releases Major Upgrade to Liquid Biopsy Test
The new test evaluates biomarkers in 739 total genes, 10 times more cancer biomarkers than the previous version of Guardant360.
Sam Brusco
07.23.24
Diagnostics
Proov Launches Proov Empower Perimenopause Testing System
Proov Empower is an at-home perimenopause test to guide hormone balance.
Rachel Klemovitch, Assistant Editor
07.23.24
Chronic Disease
|
Diagnostics
Brainomix and Boehringer Ingelheim Enter Strategic Partnership in Fibrosing Lung Disease
Brainomix’s e-Lung imaging software will be used to improve the identification and access to treatment for people with progressive pulmonary fibrosis in the US.
Rachel Klemovitch, Assistant Editor
07.22.24
Diagnostics
|
Neurological
Spryte's Neuro OCT Imaging Gets Breakthrough Status
The imaging technology allows detailed visualization of the brain’s vascular anatomy at near histologic levels.
Sam Brusco, Associate Editor
07.22.24
Diagnostics
Carestream Health Debuts Improvements to the CARESTREAM DRX-Evolution Plus System
New features aim to help radiographers more quickly confirm precise positioning for a more consistent, productive image capture.
Michael Barbella, Managing Editor
07.19.24
Diagnostics
|
Patient Monitoring
|
Software & IT
GE HealthCare to Buy Intelligent Ultrasound's Clinical AI Biz for $51M
Intelligent Ultrasound’s AI-driven image analysis tools were designed to make ultrasound smarter and boost its efficiency.
Sam Brusco, Associate Editor
07.18.24
Diagnostics
FDA Clears 9th Generation of Hyperfine's AI-Powered Swoop System Software
The software update enables faster acquisition of ultra-low-field brain images.
Sam Brusco, Associate Editor
07.17.24
Diagnostics
Danaher to Open 2 New Centers of Innovation in Diagnostics
The two labs aim to accelerate development of companion diagnostics (CDx) and complementary diagnostics (CoDx).
Sam Brusco, Associate Editor
07.17.24
Diagnostics
|
Neurological
|
Patient Monitoring
FDA OKs Positrigo's NeuroLF Brain PET Scanner
NeuroLF supports a paradigm shift in medical imaging, where a dedicated device can image a particular body part or organ.
Sam Brusco, Associate Editor
07.16.24
Diagnostics
Study Shows Advantage of Delphinus Medical's SoftVue UST in Breast Cancer Detection
The results are based on a comparison with breast cancer screening using mammography alone.
Michael Barbella, Managing Editor
07.15.24
Diagnostics
FDA OKs Philips' IntelliSite Pathology Solution 5.1
The digital pathology solution includes whole-slide scanners, an image management system, and implementation/support systems.
Sam Brusco, Associate Editor
07.12.24
Diagnostics
NOWDiagnostics Gains $22.5 Million in Series B Funding
Funds will help the development and expansion of rapid-at-home diagnostics solutions.
Rachel Klemovitch, Assistant Editor
07.09.24
Chronic Disease
|
Diagnostics
Researchers Develop Noninvasive Urine Test for Early Detection of Cervical Cancer Virus Proteins
The test is developed at Waseda University in Japan and detects oncoproteins in urine.
Rachel Klemovitch, Assistant Editor
07.09.24
Diagnostics
Avicenna.AI Gains MDR Certification for Medical Imaging AI Portfolio
The certification covers multiple algorithms that identify, detect, and quantify severe conditions from medical images.
Rachel Klemovitch, Assistant Editor
07.09.24
Diagnostics
Carestream Enhances DRX-Evolution Plus and ImageView Software
The new features aim to boost technologist experience and patient workflow.
Sam Brusco, Associate Editor
07.03.24
Breaking News
Linus Health Acquires Together Senior Health
GE HealthCare, AWS Team Up on Clinical Generative AI Apps
Align Technology Introduces iTero Design Suite
KORU Medical Systems Announces Leadership Changes
Abbott Issues Voluntary Medical Device Correction for Small Number of Freestyle Libre 3 Sensors
View Breaking News >
CURRENT ISSUE
July/August 2024
Designing Medical Devices with Human Factors Engineering
Mitigating Product Liability Risk in Supply Chains
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