Diagnostics
Industry Articles
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Diagnostics
Siemens Healthineers Starts Construction on £250M Oxford Facility
The 56,000 m2 carbon-neutral site will manufacture new MRI cooling technology.Rachel Klemovitch, Assistant Editor 05.13.24
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Diagnostics
FDA Clears QuidelOrtho's COVID-19 Test
QuickVue provides test results in 10 minutes.Michael Barbella, Managing Editor 05.10.24
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Diagnostics
Samsung Acquires Sonio, a Fetal Ultrasound AI Software Firm
The duo hopes to combine Sonio’s AI expertise with Samsung Medison’s ultrasound systems.Sam Brusco, Associate Editor 05.08.24
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Diagnostics
FDA Approves Noninvasive RNA Test for Colorectal Cancer
Geneoscopy's test is for adults aged 45 and older who are at typical risk for developing colorectal cancer.Sam Brusco, Associate Editor 05.07.24
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Diagnostics
Stephen S. Tang Named NOWDiagnostics Board Chairman
New leader is the former CEO of OraSure Technologies.Michael Barbella, Managing Editor 05.07.24
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Diagnostics | Neurological | Patient Monitoring
Rapid AI Gets FDA OK for Perfusion Imaging in the Angiography Suite
AngioFlow by RapidAI draws on validated deep clinical AI for clear, easily interpretable qualitative perfusion maps.Sam Brusco, Associate Editor 05.06.24
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Diagnostics
FDA Takes Action to Ensure Safety and Effectiveness of Laboratory-Developed Tests
A final ruling has amended FDA regulations regarding IVDs, and will outline the roll out of general enforcement over a four-year period.Rachel Klemovitch, Assistant Editor 05.03.24
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Diagnostics
Beckman Coulter Introduces CytoFLEX Nano Flow Cytometer
CytoFLEX detects, counts, and characterizes nanoparticles using a single analytical instrument.Michael Barbella, Managing Editor 05.03.24
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Diagnostics
FDA OKs United Imaging's Breakthrough 5T MRI
uMR Jupiter 5T is the first ultra-high field MRI system cleared for whole body applications.Sam Brusco, Associate Editor 05.01.24
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Diagnostics | Digital Health
Portable Stethoscope for Detecting Subtle Lung Sounds Premieres in U.S.
The next-generation ChestPal Pro is touted as the only commercially available device that can detect lung crackles and wheezes.Michael Barbella, Managing Editor 05.01.24
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Chronic Disease | Diagnostics
Toku's AI to Spot Chronic Kidney Disease Through the Eye Wins FDA Breakthrough Nod
MyKidneyAI leverages AI to analyze retinal images from routine eye exams to spot elevated CKD risk in people with diabetes.Sam Brusco, Associate Editor 04.30.24
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Chronic Disease | Diagnostics
FDA OKs Fully Autonomous AI for Portable Diabetic Retinopathy Screening
The AI diagnoses referable diabetic retinopathy from retinal images taken by a handheld camera.Sam Brusco, Associate Editor 04.30.24
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Diagnostics
Overcoming Coagulation-Drug Specific Diagnostic Challenges
Currently, no universal diagnostic test will tell you the coagulation status of a patient, agnostic to their anticoagulant drug, despite the growing need.Online Exclusives Sasha Bakhru, CEO, Perosphere Technologies 04.29.24
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Diagnostics
Health Canada Approves QuidelOrtho's Triage PLFG Test for Lab Use
Test will help physicians diagnose preterm pre-eclampsia and provide a delivery prognosis in symptomatic pregnant women.Michael Barbella, Managing Editor 04.29.24
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Diagnostics
Owlstone Medical Gains $6.5M to Develop Breath-Based Diagnostics for Infectious Diseases
Funding will support the enhancement of the Breath Biopsy platform, including the VOC Atlas.Rachel Klemovitch, Assistant Editor 04.26.24
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Cardiovascular | Diagnostics
Exo Rolls Out AI-Powered Cardiac, Lung Tools for Handheld Ultrasound
The company now has FDA 510(k) clearances on five applications: cardiac, lung, bladder, hip, and thyroid.Sam Brusco, Associate Editor 04.24.24
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Diagnostics
Spot Check: A Discussion of the In-Vitro Diagnostics Market
Nine industry experts discuss the trends and challenges impacting the in-vitro diagnostics market.Sam Brusco, Associate Editor 04.22.24
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Diagnostics
FDA OKs Ambu's New Single-Use Duodenoscopy Solution
The new generation aScope Duodeno 2 aims meet the needs of gastroenterologists performing ERCP procedures.Sam Brusco, Associate Editor 04.22.24
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Chronic Disease | Diagnostics
Lumicell's Breast Cancer Visualization System Wins FDA Approval
LumiSystem allows scanning the breast cavity post-lumpectomy, in real-time, to detect and resect residual cancer.Sam Brusco, Associate Editor 04.19.24
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Diagnostics
GE HealthCare Rolls Out New AI-Powered Ultrasound for Women's Health
The Voluson Signature 20 and 18 ultrasound systems integrate AI, advanced tools, and ergonomic design, to meet challenges in women's health.Sam Brusco, Associate Editor 04.18.24
