AVITA Medical Announces FDA 510(k) Clearance for Cohealyx, Expanding its Addressable Market
December 19, 2024 17:05 ET
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AVITA Medical
AVITA Medical announces FDA clearance for Cohealyx, a new collagen-based dermal matrix, expanding its addressable market.
Processa Pharmaceuticals Announces FDA Clearance of IND Application for a Phase 2 Clinical Trial of NGC-Cap in Breast Cancer
July 30, 2024 08:00 ET
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Processa Pharmaceuticals, Inc.
Open-label Phase 2 trial in breast cancer to begin this quarter Initial data expected mid-2025 HANOVER, Md., July 30, 2024 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (Nasdaq: PCSA)...
Curonix Receives the First Full-Body Peripheral Nerve Stimulator (PNS) FDA Clearance, including Craniofacial Pain Indication, for its Freedom® PNS System
July 09, 2024 08:00 ET
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Curonix LLC
Curonix Receives the First Full-Body Peripheral Nerve Stimulator (PNS) FDA Clearance, including Craniofacial Pain Indication, for its Freedom® PNS System.
GT Biopharma Announces FDA Clearance of Investigational New Drug (IND) Application for GTB-3650, an NK Cell Engager for Treatment of CD33+ Leukemia
June 27, 2024 09:15 ET
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GT Biopharma, Inc.
GTB-3650 Phase 1 trial initiation expected in H2 2024; initial clinical data expected in H1 2025GTB-5550 TriKE® IND submission for treatment of B7H3 positive solid tumors expected in Q1 2025GTB-5550...
BioRestorative Therapies Announces FDA Clearance of Phase 2 BRTX-100 Clinical Study Protocol Amendment
April 16, 2024 07:45 ET
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BioRestorative Therapies, Inc
— Amendment replaces saline injections with sham injections in the control group — MELVILLE, N.Y., April 16, 2024 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. (“BioRestorative”, “BRTX” or...
Biomerica Reports Second Quarter 2024 Financial Results
January 16, 2024 08:19 ET
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Biomerica, Inc.
Revenues excluding Covid test sales increased 10.3% for the second fiscal quarter of 2024 vs the second fiscal quarter of 2023.Loss per shares narrows to $0.09 per share from $0.12 per share...
Biomerica Received US FDA 510(k) Clearance for Their Hp Detect™ ELISA Test Product Designed to Detect the Presence of the H. pylori Bacteria That infects Approximately 35% of the U.S. Population
December 18, 2023 07:47 ET
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Biomerica, Inc.
Over 80% of gastric cancers are attributed to H. pylori bacterial infection Gastric cancer is the third most common cause of cancer related death in the world ...
Sleepiz AG Lands FDA 510(k) Clearance for Contactless Remote Patient Monitoring Device Measuring Vital Signs
October 10, 2023 08:00 ET
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Sleepiz USA LLC
MINNEAPOLIS, Oct. 10, 2023 (GLOBE NEWSWIRE) -- Sleepiz, a Zurich-based medical technology company providing contactless bedside patient monitoring, today announces the FDA Class II 510(k) clearance...
Bioxytran Announces FDA Clearance of its IND Application for ProLectin-M in Clinical Trials
August 24, 2023 09:00 ET
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BIOXYTRAN, INC.
First Antiviral Drug in Glycovirology BOSTON, MASSACHUSETTS, Aug. 24, 2023 (GLOBE NEWSWIRE) -- BIOXYTRAN, INC. (BIXT), (the “Company”), a clinical stage biotechnology company developing oral...
Curiteva Inc. Announces FDA 510(k) Clearance for Inspire 3D Porous PEEK HAFUSE Cervical Interbody System
February 14, 2023 07:00 ET
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Curiteva
HUNTSVILLE, Ala., Feb. 14, 2023 (GLOBE NEWSWIRE) -- Huntsville, Alabama-based technology company Curiteva announces the first FDA 510(k) cleared 3D-printed PEEK implant, the Inspire Porous PEEK...