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Saved

Topic: Diagnostics

article icon article
Diagnostics FDA Cleared Imaging

FDA clears AI for Vida Diagnostics lung imaging analysis software

Vida Diagnostics announced that it received FDA 510(k) clearance for enhancements to its AI-based LungPrint solution. […]

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Diagnostics Imaging

Ultrasound Device to Rapidly Diagnose Sickle Cell Disease

Researchers at the University of Colorado have developed a new rapid test for sickle cell […]

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Diagnostics Healthcare

CMS to cut COVID-19 pay by 25% for delayed tests, labs cries foul

Dive Brief: CMS is set to cut the payment rate to laboratories that take more […]

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AI Diagnostics Imaging

Genentech taps Imbio to develop AI programs for scanning lung diseases

Genentech has inked a multiyear partnership with Imbio to develop artificial-intelligence-powered imaging diagnostics for lung […]

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Diagnostics MedTech Orthopedic

Smith & Nephew, Quidel forecasts may signal improved ortho, diagnostic Q3s

Dive Brief: Smith & Nephew and Quidel published preliminary third-quarter results Thursday that may point […]

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Diagnostics FDA Cleared

FDA clears Masimo’s Rad-G pulse oximeter

Masimo (NSDQ:MASI) said today that FDA has granted a 510(k) clearance for its rugged handheld Rad-G […]

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Diagnostics Digital Health FDA Cleared

Cognoa Makes Push to Get FDA Nod for Digital Autism Diagnostic

Cognoa is vying for FDA clearance of a digital device that has the potential to […]

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Diagnostics Healthcare MedTech

Cellex, Gauss aim for smartphone-powered coronavirus test, offering rapid results at home

Diagnostic maker Cellex has announced plans to develop a rapid coronavirus infection test that people […]

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Diagnostics MedTech

Moody's raises medtech outlook amid testing boom at Abbott, Thermo Fisher

Dive Brief: Rising demand for COVID-19 tests and reagents at companies including Abbott and Thermo […]

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Diagnostics M&A MedTech

R&Q acquires Maetrics to expand its life science regulatory consulting

Regulatory and Quality Solutions (R&Q) has acquired Maetrics, an international life sciences quality and regulatory […]

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Diagnostics FDA Healthcare

BD probes COVID-19 false positives with point-of-care systems

Dive Brief: BD is investigating reports of false positive coronavirus test results in nursing homes […]

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Diagnostics Funding

Hologic launches $950M private offering

Hologic (NSDQ:HOLX) announced today that it launched a private offering worth $950 million in senior notes […]

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Diagnostics MedTech

20-second coronavirus screening test piloted at U.K.'s Heathrow airport

Two British companies are preparing to launch a simple COVID-19 saliva screening test that aims […]

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Cardiology Diagnostics Patient Monitoring

Bardy Diagnostics names new CEO

Bardy Diagnostics announced that it appointed Kevin Hykes as its new president, CEO and member of […]

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Diagnostics Imaging MedTech

Acutus Medical Announces Pulse Field Ablation Program and Initial Pre-Clinical Results

Breakthrough Technology, Combined with Acutus Non-Contact Mapping May Enable Rapid, Safe and Effective Arrhythmia Treatment […]

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Biotech Contract Manufacturing Diagnostics

Report: Abbott to hire 2,000 in Illinois to make rapid COVID-19 test

Abbott (NYSE:ABT) is reportedly set to hire 2,000 new employees to increase manufacturing for its rapid […]

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Diagnostics Digital Health MedTech

BREAKING: Abbott wins EUA for COVID-19 test that runs off a card

FDA this evening announced an emergency use authorization for Abbott’s BinaxNow COVID-19 Ag Card — […]

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Diagnostics FDA Healthcare

Ex-Trump FDA chief rails against new HHS policy on lab developed tests

Dive Brief: Scott Gottlieb, the Trump administration’s former FDA commissioner, took to Twitter on Saturday […]

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AI Diagnostics Digital Health

Digital Diagnostics acquires dermatology focused startup 3Derm

Autonomous AI platform Digital Diagnostics, previously known as IDx, announced that it has purchased 3Derm […]

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Diagnostics Digital Health Wearables

Fitbit Gleans Important Insights from Early Results of COVID-19 Study

A new study from Fitbit suggests that the wearable device makers technology can identify signs […]

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Diagnostics Digital Health MedTech

Smartphone App And Deep Learning Help Detect Diabetes

Diabetes is one of the world’s top causes of disease and death, affecting more than […]

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Diagnostics FDA Healthcare

FDA OKs Yale COVID-19 saliva test removing RNA extraction step

Dive Brief: FDA over the weekend granted emergency use authorization to a COVID-19 saliva test […]

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Diagnostics Orthopedic Radiology

Canon Medical Unveils SOLTUS 500 Portable X-Ray

Canon Medical is releasing a compact new mobile digital X-ray. The SOLTUS 500, powered by […]

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Diagnostics Healthcare MedTech

HHS commits $6.5M to add Thermo Fisher, Beckman Coulter COVID-19 test supplies to Aegis, Sonic labs

Dive Brief: The Department of Health and Human Services on Thursday announced $6.5 million for two […]

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Diagnostics M&A

BREAKING: Thermo Fisher drops bid for Qiagen

Thermo Fisher Scientific (NYSE:TMO) announced today that its offer to acquire Qiagen (NYSE:QGEN) in an $11.5 billion deal […]

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Diagnostics Digital Health MedTech

TestCard at-home UTI test to launch in the UK in August

TestCard has announced its noninvasive at-home urinary tract infection test kit to be launched in […]

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Biotech Diagnostics

Alphabet’s Verily opens own lab to speed up COVID testing

The buzzy life sciences company Verily is looking to speed up COVID testing with a […]

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AI Diagnostics Radiology

AI System Decides When to Help Diagnose X-Rays

Artificial intelligence is playing an ever larger role in modern clinical care. For example, there […]

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Diagnostics

State coronavirus testing targets diverge, some plan declines by December

Dive Brief: The Department of Health and Human Services on Monday afternoon released coronavirus testing […]

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Diagnostics MedTech

Hologic spending more than $50M to expand COVID-19 test production

Hologic (NSDQ:HOLX) is spending $50 million — including $14 million during its most recent quarter — […]

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Diagnostics FDA Cleared Oncology

Guardant companion diagnostic gets FDA nod as 1st liquid biopsy with NGS

Dive Brief: FDA Friday approved Guardant Health’s liquid biopsy diagnostic that uses next-generation sequencing (NGS) […]

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Biotech Diagnostics Funding

Sight Diagnostics raises $71M Series D

Blood diagnostic testing developer Sight Diagnostics announced this week that it raised $71 million in a Series […]

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Diagnostics MedTech Surgery

BD sales slide below expectations, as COVID-19 antigen test gains momentum

Dive Brief: BD on Thursday reported a 11.4% year-over-year decline in revenues to approximately $3.86 […]

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Diagnostics Funding MedTech

Sight Diagnostics raises another $71M to fully commercialize its blood analyzer

Tel Aviv, Israel-based Sight Diagnostics, which makes a complete blood count (CBC) analyzer only requiring […]

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Diagnostics FDA Healthcare

FDA authorizes first COVID-19 test for screening people without symptoms

The FDA has authorized its first COVID-19 diagnostic for broad-based screening—including for people who have […]

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Diagnostics Patient Monitoring Public Offering

Nemaura Medical announces $11.5m public offering

Nemaura Medical (NSDQ:NMRD) announced that it intends to offer shares of its common stock and warrants […]

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Diagnostics Healthcare MedTech

Medtech and COVID-19: 6 months into the public health emergency

When U.S. regulators first declared COVID-19 a public health emergency — which took effect exactly six […]

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Diagnostics FDA Healthcare

Diagnostics makers must plan for EUA products to have post-pandemic future

It’s hard to think of a product category more critical to America’s ongoing public health […]

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Contract Manufacturing Diagnostics Funding

HHS, DOD invest $7.6m in Hologic COVID-19 test samples

The U.S. Dept. of Health and Human Services (HHS) and Defense Dept. (DoD) announced a […]

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Original post by MassDevice

Written by: Sean Whooley

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