Page 39 - Breakthrough Device News Today

Neovasc Inc.: Neovasc Announces First Patient Enrollment in COSIMA Trial COronary Microvascular Angina ("COSIMA") trial. The enrollment occurred at University Hospital, Mainz, Germany. The patient is an 82-year-old woman who suffers from severe Canadian Cardiovascular Society ("CCS") Class IV angina on a daily basis despite optimal medical treatment. The study is being led by Prof. Tommaso Gori, M.D., Ph.D., University Medical Center, Mainz, Germany. COSIMA is a randomized controlled trial, s...

Date Time New saliva oral and throat cancer diagnosis test receives FDA approval A QUT researcher’s identification of saliva as an early detection liquid biopsy for oral and throat cancer has been realised by the development and commercialisation of a diagnostic device by US-based biotech company Viome. Viome’s early detection device has been designated a Breakthrough Device by The Food and Drug Administration (FDA) in the US. QUT Associate Professor Chamindie Punyadeera has spent a decade ...

/PRNewswire/ -- Cerapedics Inc., an ortho-biologics company dedicated to enhancing the science of bone repair, today announced that the U.S. Food and Drug...

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Press release content from Globe Newswire. The AP news staff was not involved in its creation. CMS Proposes Additional Payment for Shockwave’s Coronary IVL in Hospital Inpatient Cases Shockwave Medical, Inc.April 28, 2021 GMT SANTA CLARA, CALIF., April 27, 2021 (GLOBE NEWSWIRE) -- Shockwave Medical, Inc. (NASDAQ: SWAV), a pioneer in the development of Intravascular Lithotripsy (IVL) to treat severely calcified cardiovascular disease, announced today that the Centers for Medicare and Medicaid ...

Neurolutions Receives U.S. Food and Drug Administration De Novo Market Authorization for IpsiHand™ Upper Extremity Rehabilitation System April 26, 2021 07:00 ET | Source: Neurolutions Neurolutions IpsiHand also has been granted U.S. FDA Breakthrough Device Designation SANTA CRUZ, Calif. and ST. LOUIS, Mo., April 26, 2021 (GLOBE NEWSWIRE) -- Neurolutions, Inc., a medical device company developing and commercializing a first-of-its-kind device leveraging brain-compu...

FDA Authorizes Marketing of Device to Facilitate Muscle Rehabilitation in Stroke Patients News provided by Share this article Share this article SILVER SPRING, Md., April 23, 2021 /PRNewswire/ -- Today, the U.S. Food and Drug Administration authorized marketing of a new device indicated for use in patients 18 and older undergoing stroke rehabilitation to facilitate muscle re-education and for maintaining or increasing range of motion. The Neurolutions IpsiHand Upper Extremity Rehabilitation Sys...

FDA authorizes marketing of a new device for use in patients undergoing stroke rehabilitation Today, the U.S. Food and Drug Administration authorized marketing of a new device indicated for use in patients 18 and older undergoing stroke rehabilitation to facilitate muscle re-education and for maintaining or increasing range of motion. The Neurolutions IpsiHand Upper Extremity Rehabilitation System (IpsiHand System) is a Brain-Computer-Interface (BCI) device that assists in rehabilitation for st...

To embed, copy and paste the code into your website or blog: On Friday, March 26, 2021, over 180 attendees worldwide attended McKinsey & Company’s first Global HealthTech CEO Connect of 2021. The discussion focused on regulatory and legal considerations for software as a medical device (SaMD) in both the United States and Europe and specific use cases for digital therapeutics and other digital health products. Speakers included Morrison & Foerster partners Bethany Hills and Wolfgang Schönig ...

Medcura publishes successful results from clinical study Demonstrating rapid hemorrhage control and improved patient outcomes News provided by Share this article  Medcura, Inc ., a commercial-stage medical device company, announced today that it has published the results of a peer-reviewed clinical study at the University of Chicago in this months Cardiovascular Catheterization and Interventions (CCI) This first-in-human study evaluated the clinical use of the Companys FDA cleared R ³ devi...