Latest News and Press Releases

Want to stay updated on the latest news?

Sign into Reader Account Create Reader Account

June 16, 2025 09:30 ET | Source: Inquis Medical

Inquis Medical’s AVENTUS Thrombectomy System Receives FDA 510(k) Clearance for Treatment of Pulmonary Embolism

Inquis Medical's AVENTUS Thrombectomy System has received 510(k) clearance from the FDA for an expanded indication to treat pulmonary embolism.
May 28, 2025 09:00 ET | Source: Distalmotion

Distalmotion Gains FDA 510(k) Clearance for Cholecystectomy, Further Advancing Access to Robotics in the Outpatient Setting with its DEXTER® Robotic Surgery System

Lausanne, Switzerland, May 28, 2025 (GLOBE NEWSWIRE) -- Distalmotion, the global MedTech company empowering access to the benefits of robotic surgery in more sites of care, today announced that it...
May 20, 2025 08:00 ET | Source: NeurAxis, Inc.

NeurAxis Awarded First Ever FDA Clearance for the Treatment of Pediatric FAP/Functional Dyspepsia (FD) and Associated Nausea Symptoms

• Significantly expands IB-Stim’s total addressable market • Clearance covers patients aged 8–21 • Seamless go-to-market strategy with existing reimbursement and provider infrastructure ...
May 14, 2025 08:00 ET | Source: Targeted Genomics

Targeted Genomics Announces Commercial Collaboration with OraSure Technologies for Direct to Consumer (DTC) Celiac Genetic Testing

IRVINE, Calif., May 14, 2025 (GLOBE NEWSWIRE) -- Targeted Genomics LLC, developer of GlutenID, the first and only U.S. Food and Drug Administration (FDA) cleared direct-to-consumer (DTC) test for...
February 20, 2025 09:00 ET | Source: Ezra

Ezra Announces New FDA Clearance, Enhancing the Capabilities of Its Full-Body Scan Technology

Ezra, the healthcare AI startup revolutionizing early cancer detection through full-body MRI screening, announced new 510(k) clearance by the U.S. FDA.
February 17, 2025 09:00 ET | Source: Targeted Genomics

Targeted Genomics Receives FDA Clearance for First Direct-to-Consumer Celiac Disease Genetic Health Risk Test

IRVINE, Calif., Feb. 17, 2025 (GLOBE NEWSWIRE) -- Targeted Genomics LLC, a family owned genetic testing Company, today announced receipt of U.S. Food and Drug Administration (FDA) 510(k) clearance...
January 07, 2025 08:00 ET | Source: Annovis Bio, Inc.

FDA Accepts Final Protocol for Pivotal Phase 3 Alzheimer’s Disease Study, Streamlining Development Pathway

MALVERN, Pa., Jan. 07, 2025 (GLOBE NEWSWIRE) -- via IBN – Annovis Bio Inc. (NYSE: ANVS) ("Annovis" or the "Company"), a late-stage clinical drug platform company pioneering transformative therapies...
December 19, 2024 17:05 ET | Source: AVITA Medical

AVITA Medical Announces FDA 510(k) Clearance for Cohealyx, Expanding its Addressable Market

AVITA Medical announces FDA clearance for Cohealyx, a new collagen-based dermal matrix, expanding its addressable market.
July 30, 2024 08:00 ET | Source: Processa Pharmaceuticals, Inc.

Processa Pharmaceuticals Announces FDA Clearance of IND Application for a Phase 2 Clinical Trial of NGC-Cap in Breast Cancer

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)...
July 09, 2024 08:00 ET | Source: Curonix LLC

Curonix Receives the First Full-Body Peripheral Nerve Stimulator (PNS) FDA Clearance, including Craniofacial Pain Indication, for its Freedom® PNS System

Curonix Receives the First Full-Body Peripheral Nerve Stimulator (PNS) FDA Clearance, including Craniofacial Pain Indication, for its Freedom® PNS System.

Next Page keyboard_arrow_right