Diagnostics Healthcare

Medicare draft decisions may boost Natera, Myriad tests

Released on August 23, 2019

Medicare contractors published a batch of local coverage determinations Thursday relating to devices and diagnostics sold by companies including Myriad Genetics and…

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Diagnostics FDA Cleared

Drawbridge Health Receives FDA 510(k) Clearance for OneDraw™ A1C Test System

Released on August 22, 2019

MENLO PARK, Calif., Aug. 22, 2019 /PRNewswire/ — Drawbridge Health today announced that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for the…

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Diagnostics Public Offering

‘Unprecedented’ pricing pressures on Myriad send shares plunging

Released on August 14, 2019

Myriad said prices have now stabilized but the setback dented its standing with investors, wiping out some of the gains the company made after a recent UnitedHealthcare coverage decision….

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Biotech Diagnostics Funding

GNA Biosolutions raises $13.5M for its first point-of-care molecular diagnostic

Released on August 13, 2019

GNA Biosolutions raised $13.5 million to support its point-of-care molecular diagnostics platform designed to quickly examine samples taken from whole blood, sputum and…

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Biotech Diagnostics

Blood test to detect breast cancer recurrence, guide treatment, shows promise in small study

Released on August 13, 2019

A blood test for detecting small fragments of cancer DNA in breast cancer patients showed greater sensitivity than…

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Diagnostics FDA

iCubate lung infection test secures FDA breakthrough status

Released on August 7, 2019

FDA has awarded breakthrough device status to iCubate’s assay for detecting and identifying potentially pathogenic non-tuberculosis Mycobacterium (NTM)…

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Diagnostics

Breath Analyzer for Acute Respiratory Distress Syndrome

Released on August 2, 2019

Now, researchers at University of Michigan have developed a portable device that analyzes a patient’s breath to provide quick…

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Diagnostics FDA Cleared

PrisMax for Continuous Renal Replacement Therapy FDA Cleared

Released on August 2, 2019

Baxter won FDA clearance for its PrisMax system and accompanying TherMax blood warmer…

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Cardiology Diagnostics Wearables

Flexible Body Monitor Measures ECG, Breathing, Heart Rate Continuously for Weeks

Released on August 1, 2019

The device consists of a stretchable substrate with flexible built-in electrodes and appropriate electronics…

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Biotech Diagnostics

New Technology for Multiple Sclerosis Diagnosis and Management

Released on July 31, 2019

Researchers from the University of Texas at Dallas have developed a novel technology for diagnosing …

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Diagnostics MedTech

Low-Cost DIY Pump for Microfluidics Made from Balloons and Nylon Stockings

Released on July 31, 2019

The simple device, which consists of a latex balloon and nylon stockings, can pump biological samples around …

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Diagnostics FDA

FDA clears Lyme disease tests, ending reliance on immunoblots

Released on July 30, 2019

FDA has expanded the labels of four Lyme disease diagnostics to facilitate the use of a new testing paradigm…

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