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HeartFlow Receives FDA 510(k) Clearance for its Plaque Analysis and RoadMap™ Analysis
October 18, 2022 10:00 ET | HeartFlow Holding, Inc.
MOUNTAIN VIEW, Calif., Oct. 18, 2022 (GLOBE NEWSWIRE) -- HeartFlow, Inc., the leader in revolutionizing precision heart care, has received U.S. Food and Drug Administration (FDA) 510(k) clearance on...
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Oncotelic Therapeutics Receives FDA Clearance for Phase 2 Clinical Trial of OT-101/Pembroluzimab Combination for Mesothelioma (M201)
May 25, 2022 07:00 ET | Oncotelic Therapeutics, Inc.
AGOURA HILLS, Calif., May 25, 2022 (GLOBE NEWSWIRE) -- Oncotelic Therapeutics, Inc. (“Oncotelic” or the “Company”) (OTCQB:OTLC), a developer of treatments for rare and orphan indications, including...
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Nephros Receives FDA 510(k) Clearance for HDF Assist Module
May 17, 2022 07:30 ET | Nephros, Inc.
The First and Only FDA-Cleared Device Available in the United States to Provide Hemodiafiltration Therapy to Dialysis Patients SOUTH ORANGE, NJ, May 17, 2022 (GLOBE NEWSWIRE) -- via NewMediaWire –...
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G-Tech Medical Receives FDA Clearance for its Gastrointestinal Motility Monitoring System
January 13, 2022 09:00 ET | G-Tech Medical
MOUNTAIN VIEW, Calif., Jan. 13, 2022 (GLOBE NEWSWIRE) -- G-Tech Medical, a developer of non-invasive diagnostic solutions for patients with gastrointestinal disorders, today announced U.S. Food and...
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BRS Receives 510(k) Clearance from the US Food and Drug Administration for Surgical Masks
March 30, 2021 09:30 ET | Blackbriar Regulatory Services
RICHMOND, VA., March 30, 2021 (GLOBE NEWSWIRE) -- via InvestorWire – Blackbriar Regulatory Services, LLC (BRS), a firm specializing in helping small to mid-sized domestic and international companies...
Spark Biomedical’s Sparrow Therapy System™ receives FDA Clearance for Opioid Withdrawal Relief in Adults
January 04, 2021 16:38 ET | Spark Biomedical
Dallas, TX, Jan. 04, 2021 (GLOBE NEWSWIRE) -- Spark Biomedical, Inc. announced today that the U.S. Food and Drug Administration (FDA) granted 510(k) clearance to The Sparrow Therapy System, a...
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Biotricity Provides Quarter Update and Announces Continued Growth
September 01, 2020 08:00 ET | biotricity
REDWOOD CITY, Calif., Sept. 01, 2020 (GLOBE NEWSWIRE) -- Biotricity Inc. (OTCQB: BTCY), a medical diagnostic and consumer healthcare technology company, today announced record results in its...
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Biotricity Receives FDA clearance for Bioflux Software II System
August 04, 2020 08:00 ET | biotricity
REDWOOD CITY, Calif., Aug. 04, 2020 (GLOBE NEWSWIRE) -- Biotricity Inc. (OTCQB: BTCY), a medical diagnostic and consumer healthcare technology company, today announced that it has received a 510(k)...
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Ekso Bionics® Receives FDA Clearance to Market its EksoNR™ Robotic Exoskeleton for Use with Acquired Brain Injury Patients
June 25, 2020 08:30 ET | Ekso Bionics Holdings, Inc.
RICHMOND, Calif., June 25, 2020 (GLOBE NEWSWIRE) -- Ekso Bionics Holdings, Inc. (Nasdaq: EKSO) (the “Company”), an industry leader in exoskeleton technology for medical and industrial use, today...
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CHF Solutions receives 510(k) clearance for Aquadex SmartFlow™ system in Pediatric Patients Weighing 20kg or More
February 26, 2020 08:00 ET | CHF Solutions, Inc.
EDEN PRAIRIE, Minn., Feb. 26, 2020 (GLOBE NEWSWIRE) -- CHF Solutions (Nasdaq: CHFS) today announced FDA 510(k) clearance in the U.S. of its next generation Aquadex SmartFlow console for use in adult...