PAVmed Inc. (the “Company” or “PAVmed”), a highly differentiated, multi-product medical device company, today announced that its majority owned subsidiary, Lucid Diagnostics Inc. (“Lucid”), has received 510(k) marketing clearance for its EsoCheck Cell Collection Device™ (“EsoCheck”) from the U.S. Food and Drug Administration (FDA).
EsoCheck is a non-invasive cell collection device that is designed to sample cells from a targeted region of the esophagus in a five-minute office-based
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Mount Sinai, Philips, LabCorp to Launch Digital & AI-Enabled Pathology Center of Excellence
Mount Sinai, LabCorp, and Philips announced they are collaborating to establish the Mount Sinai Digital and Artificial Intelligence (AI)-Enabled Pathology Center of Excellence. The new center will feature the Philips IntelliSite Pathology Solution, the first digital pathology system FDA approved for primary diagnostic use, which will help the organizations enhance the quality and lower the costs of patient care.Role of LabCorpLabCorp will lead the integration of Philips’ system at Mount Sinai,
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IBM, KPMG, Merck and Walmart to Launch FDA Blockchain Pilot Program
IBM, KPMG, Merck, and Walmart today announced that the companies have been selected by the United States Food and Drug Administration (FDA) to be included in a blockchain pilot program in support of the U.S. Drug Supply Chain Security Act (DSCSA) that addresses requirements to identify, track and trace prescription medicines and vaccines distributed within the United States.Pilot Program OverviewThe FDA pilot program is intended to evaluate the use of blockchain technology to assist drug supply
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Companion Medical Integrates Smart Insulin Pen with Rimidi Diabetes Management App
Rimidi and Companion Medical announced a first-of-its-kind partnership to enhance data visualization for clinicians treating high-risk patients with diabetes who are on insulin therapy. The collaboration integrates Companion Medical’s connected device, InPen™, the first and only FDA-cleared, smart insulin pen paired with an integrated diabetes management app, into Rimidi’s platform by pushing insulin dosing data from the InPen through the cloud.Integration BenefitsThis partnership reduces the
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Flow Launches Medical-Grade Headset, Therapy App for Depression
Flow, a medical device company launches a medication-free treatment for depression comprising a brain stimulation headset and therapy app. In Europe, Flow has been approved as a Class II medical device intended for use as a treatment for depression - and is the first approved treatment of its kind in Europe available to buy and use at home.Flow BackgroundBased in Sweden, Flow was developed by clinical psychologist Daniel Mansson and neuroscientist Erik Rehn, together with a team of prominent
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Medivis Granted FDA 510(k) Clearance for Surgical Augmented Reality Platform
Medivis, a New York City-based medical technology company harnessing augmented reality and artificial intelligence to advance surgical visualization has received 510(k) clearance for clinical use in the operating room by the U.S. Food and Drug Administration (FDA).Most medical procedures are performed relatively blindly, with surgeons having to reconstruct slices of 2D imaging data in the “mind’s eye” to make it actionable. Founded by neurosurgeon Osamah Choudhry, MD and radiologist Christopher
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You Want Patient Engagement? Make The System Navigable
Irv Lichtenwald, President & CEO of Medsphere Systems Corporation
Last month, New York Times reporter Robert Pear died at age 69 from complications of a stroke. The name was unfamiliar to me, and I guess that’s to be expected, given what I’ve learned of the man since.
Turns out Robert Pear was a thoughtful, unassuming reporter who wanted the accuracy and validity of his work to speak for him. This approach engendered much respect among his peers in the 40 years that he primarily covered
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Pillo Health Raises $11M to Expand Personal Home Health Robot
Pillo Health, a Boston-based digital health company improving longevity and quality of life for patients managing their health at home has raised $11M in Series A funding, led by Stanley Black & Decker’s corporate venture capital arm with significant participation from Samsung Ventures. Existing investors, including BioAdvance, Hikma Ventures – the corporate venture capital arm of Hikma Pharmaceuticals PLC – Hackensack Meridien Health System’s Innovation Center Fund and
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3 Major Problems With the Medical Device and Wearables Market in 2019
Technology can improve human life in significant ways and aid in the fight against troublesome illnesses. Unfortunately, no technology is perfect — and newer technologies are especially prone to growing pains.There are three major problems in today's medical devices and wearables market: potential sabotage of the devices themselves, devices as a backdoor into networks and patient data, and device manufacturers taking advantage of regulatory loopholes to get their products on the market.1. Many
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FDA Clears First Smartphone-Controlled Migraine Wearable Device
Today, Theranica announced that the FDA has granted De Novo clearance for Nerivio Migra, the first-ever smartphone controlled wearable for the acute treatment of migraines. Worn on the upper arm, Nerivio Migra utilizes remote electrical neuromodulation for the acute treatment of migraine that is proven to be as effective as leading devices and drugs on the market in treating acute migraine, with fewer and more mild side effects.Migraine is the third most common disease in the world, with an
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