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Tag: U.S. Food and Drug Administration

Vivos Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Operational Update | BioSpace

Positive Business Momentum and Sales Pipeline Growth Following FDA 510(k) Clearance of Vivos’ Proprietary Oral Medical Devices to Treat Severe Obstructive Sleep Apnea Annual Operating...

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FDA Grants Humanitarian Device Exemption Approval to SeaStar Medical’s Selective Cytopheretic Device for Pediatric Acute Kidney Injury | BioSpace

SCD-PED (Pediatric) is the first FDA-approved product in the Company’s Quelimmune™ product family DENVER, Feb. 22, 2024 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq:...

Iveda launches IvedaAI Sense: AI sensor detects vaping and bullying | IoT Now News & Reports

Iveda has introduced IvedaAI Sense, an AI-based sensor that can detect smoke and vapor particles and incidents of bullying. Integrated into the IvedaAI platform,...

X-trodes Receives FDA 510(k) Clearance for Wearable “Skin” Solution that Brings Medical-Grade Electrophysiological Monitoring to the Home | BioSpace

Next-Generation Skin Patch-based Monitoring Platform Enables Complete Freedom of Movement for Patients in Both Healthcare and Home Settings HERZLIYA, Israel, Feb. 20, 2024 /PRNewswire/ --...

MCRA Assists Curiteva Inc. with FDA 510(k) Clearance for Inspire 3D Printed Trabecular PEEK Lumbar Interbody Fusion System | BioSpace

  WASHINGTON, Feb. 20, 2024 /PRNewswire/ -- MCRA, the leading privately held independent medical device, diagnostics, and biologics Clinical Research Organization (CRO) and advisory firm is...

Curavit Successfully Completes a Virtual Clinical Trial for Sana’s Investigative Digital Therapeutic to Treat Symptoms of PTSD | BioSpace

NEW YORK, Feb. 12, 2024 /PRNewswire/ -- Curavit Clinical Research, a virtual contract research organization (VCRO) that specializes in decentralized clinical trials (DCTs) for...

Baird Medical Performs First Thyroid Microwave Ablation Procedure in the United States | BioSpace

FRISCO, Texas, Jan. 23, 2024 /PRNewswire/ -- Baird Medical Devices, Inc. ("Baird Medical" or the "Company"), a leading microwave ablation ("MWA") medical device developer...

NeuroSigma Announces FDA Clearance of its Second-Generation Monarch eTNS System for Treating Pediatric ADHD | BioSpace

LOS ANGELES, Jan. 17, 2024 (GLOBE NEWSWIRE) -- NeuroSigma today announced that the U.S. Food and Drug Administration (FDA) cleared use of NeuroSigma’s second-generation...

The Scientific Advisory Group (SAG) to Convene to Discuss the Marketing Authorization Application for lecanemab in the EU

TOKYO, Jan 11, 2024 - (JCN Newswire) - Eisai Co., Ltd. announced today that the Scientific Advisory Group (SAG) will convene to discuss the...

Avanos Medical, Inc. Reports Preliminary Fourth Quarter and Full-Year 2023 Financial Results; Revises Preliminary 2024 Revenue Outlook | BioSpace

ALPHARETTA, Ga., Jan. 4, 2024 /PRNewswire/ -- Avanos Medical, Inc. (NYSE: AVNS) today reported selected, unaudited preliminary financial results for the fourth quarter and...

Will This Be Our Year?

In 1919, a ban on alcohol exposed a cultural divide between urban and rural America and led to a spike in organized crime. Federal,...

Kleinfeld Kaplan & Becker LLP Announces Election of Samantha N. Hong as Partner – Medical Marijuana Program Connection

WASHINGTON–(BUSINESS WIRE)–Kleinfeld Kaplan & Becker LLP (KKB) is pleased to announce that Samantha N. Hong has been elected to the partnership effective January 1,...

ABK Biomedical announces that its Eye90 microspheres device has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) | BioSpace

HALIFAX, NS, Dec. 5, 2023 /PRNewswire/ - ABK Biomedical, Inc., an innovative, medical device company dedicated to the research, development, and commercialization of advanced...

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