Diagnostics
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Diagnostics
FDA Grants De Novo Clearance to Medtronic’s GI Genius Model
Assists physicians in detecting pre-cancerous growths, potentially addressing 19 million colonoscopies annually.Charles Sternberg, Assistant Editor 04.15.21
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Diagnostics
DiaSorin to Buy Luminex for $1.8B
Provides access to proven Luminex multiplexing technology and molecular testing solutions.Sam Brusco, Associate Editor 04.13.21
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Diagnostics
Avantor to Acquire Ritter GmbH and Affiliates for $1B
Expands proprietary offering for diagnostic and drug discovery workflows.Sam Brusco, Associate Editor 04.12.21
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Diagnostics
Hologic to Buy Mobidiag for $795M
Hologic gains near-patient, acute care diagnostic testing platforms.Sam Brusco, Associate Editor 04.08.21
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Diagnostics
EKF Launches STAT-Site WB β-Ketone and Glucose Handheld Analyzer
Company obtains CE mark certification alongside CLIA waiver for easy-to-use whole blood analyzer for diabetes care programs.Michael Barbella, Managing Editor 04.07.21
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Diagnostics
PPE and Diagnostics: Sourcing Domestically and Speeding Time to Market
With smart onshoring strategies, the medical device industry can collaborate to fix supply chain issues.Claudio Hanna and Ralph Tricomi , Web Industries 04.01.21
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Diagnostics
BD Gains EUA for Asymptomatic COVID-19 Screening via Rapid Testing
BD Veritor Plus System supports return-to-school and return-to-work programs through serial testing.Sam Brusco, Associate Editor 04.01.21
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Diagnostics
Abbott's Rapid COVID-19 Self-Test Receives EUA
Permits asymptomatic, non-prescription, over-the-counter self-use for people with or without symptoms.Sam Brusco, Associate Editor 04.01.21
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Diagnostics
Diagnosing the IVD Market: An Interview with TEAM Technologies
Chief revenue officer Steve Lents discusses the in-vitro diagnostic market and manufacturing rapid antigen POC COVID-19 tests.Online Exclusives Sam Brusco, Associate Editor 03.30.21
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Diagnostics
BD's Combo COVID-19, Flu Rapid Antigen Test Earns EUA
Can detect SARS-CoV-2, influenza A, influenza B from a single patient sample in 15 minutes.Sam Brusco, Associate Editor 03.30.21
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Diagnostics
FDA OKs GE Healthcare's New 3D Surgical Imaging System
OEC 3D brings precise 3D and 2D imaging to surgical suites, improving efficiency.Sam Brusco, Associate Editor 03.25.21
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Diagnostics
Optellum Receives FDA Clearance for Virtual Nodule Clinic
Empowers clinicians to make optimal clinical decisions in early-stage lung cancer diagnosis and is now commercially available in the U.S.Charles Sternberg, Assistant Editor 03.23.21
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Diagnostics
FDA Authorizes Machine Learning-Based COVID-19 Biomarker Screening Device
Identifies biomarkers that may be indicative of SARS-CoV-2 infection as well as other hypercoagulable conditions.Sam Brusco, Associate Editor 03.23.21
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Diagnostics
GE Healthcare Reveals Vscan Air Wireless, Handheld Ultrasound
Touts dual-probe whole-body scanning capabilities.Sam Brusco, Associate Editor 03.17.21
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Diagnostics
FDA OKs Olympus' Narrow Band Imaging to Assess Colonic Lesions
New evidence supports NBI to characterize polyps found during screening colonoscopies for colorectal cancer.Sam Brusco, Associate Editor 03.16.21
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Diagnostics
Roche to Acquire GenMark Diagnostics for $1.8B
GenMark’s syndromic panel testing portfolio complements Roche’s current molecular diagnostics portfolio.Sam Brusco, Associate Editor 03.15.21
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Diagnostics
FDA Issues EUA to First OTC Home Molecular COVID-19 Test
Results from the Cue COVID-19 test are sent directly to a companion app in about 20 minutes.Sam Brusco, Associate Editor 03.08.21
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Diagnostics
Avacta’s Rapid Antigen Test Proves Effective for New Coronavirus Variants
Detects the B117, or ‘Kent’, variant, and the D614G variant, as well as the original strain.Charles Sternberg, Assistant Editor 03.08.21
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Diagnostics
EUA Granted for New COVID-19, Flu A, Flu B Combo Kit
One multiplex real-time PCR diagnostic kit can simultaneously detect and differentiate SARS-CoV-2, influenza A and influenza B.Michael Barbella, Managing Editor 03.05.21
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Diagnostics
EchoNous Expands Its Kosmos Hardware Platform
Adds continuous wave and pulsed wave Doppler capabilities.Charles Sternberg, Assistant Editor 03.04.21
