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October 24, 2025 08:00 ET | Source: NeurAxis, Inc.

NeurAxis Awarded First Ever FDA Clearance for the Treatment of Pain in Functional Dyspepsia (FD) with associated Nausea Symptoms in the Adult Patient Population

Achieves significant expansion of NeurAxis’ total addressable marketClearance now includes patients aged “8 years and older”Expanded age indication will utilize the upcoming January 1st, 2026,...
October 01, 2025 09:00 ET | Source: Distalmotion

Distalmotion Secures Third FDA Clearance for DEXTER® with Hysterectomy Indication

Lausanne, Switzerland, Oct. 01, 2025 (GLOBE NEWSWIRE) -- Distalmotion, the global MedTech company empowering access to the benefits of robotic surgery in outpatient sites of care, today announced...
September 30, 2025 08:00 ET | Source: Zenflow

Zenflow Receives FDA 510(k) Clearance for First-of-Its-Kind Single-Use Cystoscope

Zenflow, Inc. announced it has received 510(k) clearance from the US FDA for the Zenflow Spring® Scope & Camera Control Unit.
September 22, 2025 16:05 ET | Source: Heartflow, Inc.

Heartflow Announces FDA 510(k) Clearance and Launch of Next Generation Heartflow Plaque Analysis Platform

MOUNTAIN VIEW, Calif., Sept. 22, 2025 (GLOBE NEWSWIRE) -- Heartflow, Inc. (Heartflow) (Nasdaq: HTFL), the leader in AI technology for coronary artery disease (CAD), today announced it has received...
September 10, 2025 09:00 ET | Source: neurocare group AG

neurocare group's Apollo TMS Therapy Devices Now Have FDA Clearance to Treat Adolescents Suffering With Major Depression

Access to Apollo TMS Therapy has expanded in the United States, extending coverage to Adolescents suffering from Major Depression.
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.