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

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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® allows the 4 key vital parameters to be taken in 5 minutes, rapidly identifying the…

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

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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 use the new Omni hysteroscope in out- and in-patient settings. “Experts agree that direct visualization…

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HIMSS Announces Cancellation of the 2020 Global Health Conference & Exhibition

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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 into preparing for their presentations and panels that accompany every HIMSS conference,” said Hal Wolf,…

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

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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 actually proposing it, as pressure mounted from lawmakers in recent months to follow through on…

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

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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 a chest-worn wireless sensor that accurately detects when someone is suffering Opioid Indused Respiratory Depression…

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XaTek’s ClotChip Earns FDA’s Breakthrough Device Designation

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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. The FDA Breakthrough Devices Program was created in 2018 to expedite the development, assessment and…

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U.S. FDA Grants PAVmed Subsidiary, Lucid Diagnostics, Breakthrough Device Designation for its EsoGuard Esophageal DNA Test 

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PAVmed Inc., a highly differentiated, multiproduct medical device company, today announced that the Company’s majority owned subsidiary, Lucid Diagnostics Inc. (“Lucid”), has received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for its EsoGuard™ Esophageal DNA Test on esophageal samples collected using its EsoCheck™ Cell Collection Device in a prevalent well-defined group…

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ReadCoor, Inc. Unveils True Spatial Sequencing Platform to Drive Groundbreaking Insights into Immuno-oncology, Neuroscience, and Infectious Disease 

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ReadCoor, Inc., a company leading true multi-omic spatial sequencing, today unveils its first product line, including multi-omic spatial sequencing assays and the RC2 instrument. The platform is powered by ReadCoor’s proprietary FISSEQ (Fluorescent in situ Sequencing) technology, which combines the massive multiplexity of next-generation sequencing (NGS) and high-resolution tissue imaging. The fully integrated platform is now available for use by researchers…

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ImmunoPrecise Launches Coronavirus Vaccine and Therapeutic Antibody Program

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ImmunoPrecise Antibodies Ltd (the “Company”), a provider of best-in-class therapeutic antibody discovery capabilities for the global industry, announces its commitment to the development of innovative vaccines against the new coronavirus originating in Wuhan, China (SARS-CoV-2) as well as coronavirus-neutralizing antibodies, addressing both prophylactic and therapeutic measures to fight the virus and its associated disease, COVID-19. IPA’s Rapid Research…

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Flowonix Receives FDA Approval to Market Prometra II Pump for use with Intrathecal Baclofen

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Flowonix Medical, Inc. today announced United States Food and Drug Administration (FDA) approval to market the Prometra II Programmable Pump System for use with intrathecal baclofen. Flowonix introduced the Prometra II 40mL pump to the US market in November 2019, providing patients and clinicians a choice between 20 mL and 40 mL capacities when choosing an…

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