FDA Accepts DrugSorb-ATR De Novo Application To Reduce the Severity of CABG-Related Bleeding Due to Ticagrelor and Initiates Substantive Review
October 22, 2024 07:00 ET
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CytoSorbents
FDA Accepts DrugSorb-ATR De Novo Application To Reduce CABG-Related Bleeding Severity Due To Brilinta, Starting Substantive Review, 2025 Decision Expected
Kane Biotech Receives FDA Approval to Increase Dosage Allowance of its revyve™ Antimicrobial Wound Gel
July 23, 2024 08:30 ET
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Kane Biotech Inc.
WINNIPEG, Manitoba, July 23, 2024 (GLOBE NEWSWIRE) -- Kane Biotech Inc. (TSX- V:KNE; OTCQB:KNBIF) (“Kane Biotech”, “Kane” or the “Company”) announces that the US Food and Drug Administration (FDA)...
Kane Biotech Receives ISO 13485:2016 MDSAP Quality Certification
July 17, 2024 08:30 ET
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Kane Biotech Inc.
WINNIPEG, Manitoba, July 17, 2024 (GLOBE NEWSWIRE) -- Kane Biotech Inc. (TSX-V:KNE; OTCQB:KNBIF) (“Kane Biotech” or “Kane”) announces that it has received ISO 13485:2016 Medical Device Single Audit...
Daxor Corporation Submits Dual 510(k)/CLIA-waiver Application to the FDA for Its Advanced Next-Generation Blood Volume Analyzer
January 02, 2024 08:30 ET
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Daxor Corporation
The New BVA System is Designed to be Significantly Faster, Simpler and Give Results at the Bedside Oak Ridge, TN, Jan. 02, 2024 (GLOBE NEWSWIRE) -- Daxor Corporation (Nasdaq: DXR), the global...
NeuroSigma Announces FDA 510(k) Submission for Second Generation Monarch eTNS System
November 07, 2023 08:50 ET
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NeuroSigma, Inc.
LOS ANGELES, Nov. 07, 2023 (GLOBE NEWSWIRE) -- NeuroSigma today announced it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for its second-generation...
Acuitive Technologies Receives FDA 510(k) Clearance for CITRELOCK DUO a New Sports Medicine Fixation Device for Biceps Tenodesis and Tendon Transfer Procedures
September 27, 2023 15:50 ET
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Acuitive Technologies
ALLENDALE, N.J., September 27, 2023 -- Acuitive Technologies announced the FDA 510(k) Clearance of CITRELOCK DUO Fixation Device for biceps tenodesis
Northeast Scientific Inc. awarded 510(k) clearance to reprocess the Eagle Eye Platinum RX Digital IVUS Catheter
February 06, 2023 14:56 ET
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Northeast Scientific, Inc.
WATERBURY, Conn., Feb. 06, 2023 (GLOBE NEWSWIRE) -- Northeast Scientific Inc., the pioneers in reprocessing single use peripheral vascular catheters, announced this week it has received FDA 510(k)...
Accelerate Diagnostics Investigated by Block & Leviton For Potential Securities Law Violations; Investors Who Have Lost Money Are Encouraged to Contact the Firm
October 24, 2022 12:40 ET
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Block & Leviton LLP
BOSTON, Oct. 24, 2022 (GLOBE NEWSWIRE) -- Block & Leviton is investigating Accelerate Diagnostics, Inc. (NASDAQ: AXDX) for potential securities law violations. Investors who have lost money in...
Northeast Scientific Inc. wins 510(k) for Turbo-Elite Laser Atherectomy Catheter reprocessing
July 26, 2022 10:44 ET
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Northeast Scientific, Inc.
WATERBURY, Conn., July 26, 2022 (GLOBE NEWSWIRE) -- Northeast Scientific Inc., the pioneers in reprocessing single use peripheral vascular catheters, announced this week it has received FDA...
ROSEN, A TRUSTED AND LEADING LAW FIRM, Encourages Pulse Biosciences, Inc. Investors with Losses to Secure Counsel Before Important Deadline in Securities Class Action – PLSE
March 16, 2022 20:30 ET
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The Rosen Law Firm PA
NEW YORK, March 16, 2022 (GLOBE NEWSWIRE) -- WHY: Rosen Law Firm, a global investor rights law firm, reminds purchasers of the securities of Pulse Biosciences, Inc. (NASDAQ: PLSE) between January...