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Diagnostics & Healthcare News

Nuclein Speeds Commercialization of First Ever Hand-Held PCR Test to Aid in COVID-19 Pandemic 

Nuclein LLC announces plans to expedite the commercialization of its Nuclein™ Hand-Held PCR Test. The company’s disposable, all-in-one, self-test device for infectious disease diagnosis does not require technical expertise and provides battery-powered, sample-to-answer results in under one hour, without the need...

March 23, 2020

Diagnostics & Healthcare News

Intuitive Surgical Among 1st Big Medtech Companies to Warn of Costly Pandemic Disruptions 

Intuitive said the disruptions it’s felt to date in China, Korea, Taiwan and Italy “do not represent a material portion of our current procedure volume.” n Intuitive’s most critical U.S. market, infections are rising and rapid implementation of mitigation strategies...

March 19, 2020

Diagnostics & Healthcare News

Hologic’s Molecular Test for the Novel Coronavirus Receives FDA Emergency Use Authorization 

Hologic, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for the Company’s new Panther Fusion® SARS-CoV-2 assay, a molecular diagnostic test that detects SARS-CoV-2, the virus that causes COVID-19 disease. Hospital, public health...

March 17, 2020

Diagnostics & Healthcare News

The Consult Station: Front-Line Detection and Triage to Contain the Spread of Covid-19 

H4D, a leading global telemedicine company, is joining the international effort to fight the global coronavirus pandemic. H4D is providing hospitals with a fast, efficient and reliable solution to improve patient flow management in the emergency department. The Consult Station®...

March 17, 2020

Diagnostics & Healthcare News

Hologic Receives CE Mark for Three-in-One Omni Hysteroscope in Europe 

Hologic, Inc. (Nasdaq: HOLX) announced today that it has received a CE mark in Europe for its Omni™ hysteroscope, an innovative three-in-one modular scope with advanced visualization capabilities designed for both diagnostic and therapeutic hysteroscopic procedures. Obstetricians and gynecologists (ObGyns) can...

March 10, 2020

Diagnostics & Healthcare News

HIMSS Announces Cancellation of the 2020 Global Health Conference & Exhibition

Today, following recent reports from the World Health Organization (WHO) and the Centers for Disease Control and Prevention (CDC), HIMSS announced it is clearly necessary to cancel the 2020 HIMSS Global Health Conference & Exhibition. “We recognize all the hard work that so many have put...

March 5, 2020

Diagnostics & Healthcare News

FDA Bans Certain Electrical Stimulation Devices, the Third Ban in History

FDA has officially banned electrical stimulation devices used to treat self-injury or aggressive behavior with publication of a final rule Wednesday. The action comes almost six years after convening an advisory committee to weigh the ban and four years after...

March 4, 2020

Diagnostics & Healthcare News

Altair Medical Awarded FDA Breakthrough Device Status to Address the Global Opioid Crisis

Altair Medical, a medical technology company developing a groundbreaking solution to the global opioid crisis, today announce that the US Food and Drug Administration (FDA) has awarded the Company Breakthrough Device designation for its RESPMETERTM wearable biosensor device. Altair Medical’s RESPMETERTM is...

March 4, 2020

Diagnostics & Healthcare News

XaTek’s ClotChip Earns FDA’s Breakthrough Device Designation

XaTek Inc. today announced that the company has received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for its in-development ClotChip, marking a significant and distinguishing step in advancing the company’s life-changing portable blood-clotting sensor toward commercialization....

March 3, 2020