Exactech Reports the US FDA 510(k) Clearance of Equinoxe Scapula Reconstruction System for Acromial Stress Fractures

Shots: Exactech has received the US FDA 510(k) clearance for the Equinoxe Scapula Reconstruction System to treat acromial & scapular spine fractures; limited US pilot launch is expected later this year Equinoxe Scapula Reconstruction System allows orthopedic surgeons to treat scapular fractures using single & dual plating techniques, which is compatible with any rTSA implant…

ByRidhi RastogiJuly 10, 2025

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Mendaera’s Focalist Robotic System Secures the US FDA 510(k) Clearance for Ultrasound-Guided Procedures

Shots: Mendaera has received the US FDA’s 510(k) clearance for Focalist robotic system for ultrasound-guided procedures Mendaera will begin a limited launch of its Focalist system in 2025 to initially support urology procedures like PCNL, expanding to other specialties, with full commercialization expected in 2026 Focalist is designed to support precise & consistent needle placement…

ByRidhi RastogiJuly 9, 2025

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Fasikl Reports the US FDA’s 510(k) Clearance of Felix NeuroAI Wristband to Treat Essential Tremors

Shots: The US FDA has granted 510(k) clearance to Felix NeuroAI Wristband for the treatment of essential tremor in the upper limbs of the adults; available in select US states in 2025, with nationwide availability anticipated in 2026 Clearance was supported by TRANQUIL study assessing Felix wristband vs sham device, which showed reduced tremors & improved…

ByRidhi RastogiJuly 2, 2025

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Brain Navi Biotechnology Reports the US FDA’s 510(k) Clearance of NaoTrac for Neurosurgical Procedures

Shots: Brain Navi Biotechnology has received the US FDA’s 510(k) clearance for NaoTrac neurosurgical robot NaoTrac is a stereotaxic guiding surgical device that uses SMART tech for rapid, non-contact, frameless registration by aligning the pts anatomy with preoperative imaging, & a robotic arm to guide instruments while keeping the surgeon in control NaoTrac integrates AI…

ByRidhi RastogiJune 18, 2025

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Inquis Medical Reports the US FDA’s 510(k) Clearance of AVENTUS Thrombectomy System to Treat Pulmonary Embolism

Shots: The US FDA has granted 510(k) clearance to the AVENTUS Thrombectomy System for the treatment of pulmonary embolism (PE), expanding its prior clearance for use in the peripheral vasculature AVENTUS was evaluated in a completed pivotal IDE trial for aspiration thrombectomy with filtered blood reinfusion in intermediate-risk PE pts, which showed rapid improvement in…

ByRidhi RastogiJune 17, 2025

NEWS

Neurent Medical Receives the US FDA’s 510(k) Clearance of NEUROMARK System for Chronic Rhinitis

Shots: The US FDA has granted 510(k) clearance to the next generation NEUROMARK system for pts with chronic rhinitis The new system optimizes posterior nasal nerve treatment by providing real-time feedback for accurate electrode placement & confirming treatment delivery, with a flexible shaft & atraumatic leaflets that conform to pts anatomy for maximizing treatment coverage…

ByRidhi RastogiJune 12, 2025

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LEX Diagnostics Seeks 510(k) Clearance and CLIA Waiver Status for its VELO system to Deliver Highly Sensitive PCR Results

Shots: The US FDA has received 510(k) clearance & CLIA waiver application of VELO system for highly sensitive PCR results for respiratory pathogens LEX Diagnostics has completed US trials of the VELO system & Influenza/COVID assay during the 2024/2025 season & expects 510(k) clearance by late 2025 or early 2026, pending FDA review VELO system…

ByRidhi RastogiJune 9, 2025

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The US FDA Grants 510(k) clearance to Stryker’s OptaBlate BVN System for Vertebrogenic Pain

Shots: The US FDA has granted 510(k) clearance to the OptaBlate BVN system for minimally invasive procedure designed to deliver long-lasting relief from vertebrogenic pain OptaBlate BVN achieves ≥1cm lesions in 7min. & features a steerable curved introducer, with microinfusion tech to minimize impedance & charring, plus 10-gauge access tools for precision OptaBlate BVN combines…

ByRidhi RastogiMay 20, 2025

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Median Technologies Seeks the US FDA’s 510(k) Clearance of eyonis LCS for Lung Cancer Detection

Shots: The US FDA has received application for 510(k) clearance of eyonis Lung Cancer Screening (LCS) to detect & diagnose lung cancer, with clearance expected in Q3'25 Submission is backed by 2 studies, REALITY & RELIVE, both of which met their 1EP; REALITY depicted an AUC of 0.904 (vs 0.80 threshold), accurately detecting early lung…

ByRidhi RastogiMay 14, 2025

NEWS

Teleflex’s QuikClot Control+ Hemostatic Device Receives the US FDA’s 510(k) Clearance to Temporary Control All Bleeding Grades

Shots: The US FDA has granted 510(k) clearance for label expansion of QuikClot Control+ Hemostatic Device to control all grades of internal & external bleeding Label expansion was supported by real-world evidence from an observational study evaluating QuikClot Control+ in 603 US emergency, trauma, & surgical pts across all bleeding grades & varied anatomical sites…

ByRidhi RastogiApril 30, 2025

Exactech Reports the US FDA 510(k) Clearance of Equinoxe Scapula Reconstruction System for Acromial Stress Fractures

Mendaera’s Focalist Robotic System Secures the US FDA 510(k) Clearance for Ultrasound-Guided Procedures

Fasikl Reports the US FDA’s 510(k) Clearance of Felix NeuroAI Wristband to Treat Essential Tremors

Brain Navi Biotechnology Reports the US FDA’s 510(k) Clearance of NaoTrac for Neurosurgical Procedures

Inquis Medical Reports the US FDA’s 510(k) Clearance of AVENTUS Thrombectomy System to Treat Pulmonary Embolism

Neurent Medical Receives the US FDA’s 510(k) Clearance of NEUROMARK System for Chronic Rhinitis

LEX Diagnostics Seeks 510(k) Clearance and CLIA Waiver Status for its VELO system to Deliver Highly Sensitive PCR Results

The US FDA Grants 510(k) clearance to Stryker’s OptaBlate BVN System for Vertebrogenic Pain

Median Technologies Seeks the US FDA’s 510(k) Clearance of eyonis LCS for Lung Cancer Detection

Teleflex’s QuikClot Control+ Hemostatic Device Receives the US FDA’s 510(k) Clearance to Temporary Control All Bleeding Grades

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