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 Q3'25Submission 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

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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 bleedingLabel 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

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CIRCA Scientific Reports the US FDA’s 510(k) Clearance of PeriCross Epicardial Access Kit for Controlled Pericardial Space Access

Shots:The US FDA has granted 510(k) clearance to PeriCross for controlled & efficient access to pericardial space through subxiphoid approach; US launch expected in coming mos., with select global expansion planned for 2026Preliminary EASY-R trial data (enrolment completed) in 21 pts showed 100% access success, with mean access time of 3.5 ± 2.2min,…

ByRidhi RastogiApril 25, 2025

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Ceribell’s Clarity Algorithm Receives the US FDA’s 510(k) Clearance to Detect Electrographic Seizures in Pediatric Patients

Shots:The US FDA has granted 510(k) clearance to Clarity algorithm for the detection of electrographic seizures in pts (≥1yrs.)Pediatric clearance was backed by extensive electroencephalography (EEG) dataset developed from ~1,700 pts to detect non-convulsive seizures, ensuring rapid diagnosis & prevention of serious brain injuryClarity algorithm allows seizure detection in both pediatric &…

ByRidhi RastogiApril 17, 2025

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AliveDx Seeks the US FDA’s 510(k) Clearance for MosaiQ AiPlex Connective Tissue Diseases (CTDplus) Multiplex Microarray

Shots:The US FDA has received 510(k) application for MosaiQ AiPlex CTDplus multiplex microarray to improve & accelerate diagnosis of connective tissue diseases (CTDs)CTDplus diagnose CTDs using just 10μL of sample in one step, with its CTD microarray having 15 markers in each panel per pts—DFS70/LEDGF, CCP, dsDNA, Sm, Sm/RNP, U1RNP, Chromatin, Ribosomal P,…

ByRidhi RastogiApril 7, 2025

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The US FDA Grants 510(k) Clearance to Teleflex’s AC3 Range Intra-Aortic Balloon Pump (IABP) for Cardiac Patient Mobility

Shots:The US FDA has granted 510(k) clearance to the AC3 Range IABP, which will enter full market release in the US & begin shipping in Q2’25AC3 Range allows reliable IABP support during multiple pts transport modes, incl. ambulances & fixed or rotary-wing aircraftAC3 Range integrates the AC3 Optimus IABP’s interface & algorithms…

ByRidhi RastogiApril 2, 2025

NEWS

Huntleigh Healthcare Reports the US FDA’s 510(k) Clearance of Dawes-Redman CTG Analysis to Improve Non-Stress Test Interpretation in Fetuses

Shots:The US FDA has granted 510(k) clearance to the Dawes-Redman CTG analysis, improving non-stress test (NST) interpretation in fetuses to help prevent poor outcomes for babies & familiesDawes-Redman CTG assesses NST traces against criteria of normality, using database of 100,000+ traces & their outcomes, by evaluating basal heart rate, sinusoidal rhythms, & short-term…

ByRidhi RastogiMarch 26, 2025

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Perfuze Secures the US FDA’s 510(k) Clearance for its Zipline Access Catheters

Shots:The US FDA has granted 510(k) clearance to Zipline Access Catheters to treat acute ischemic strokes Zipline improves delivery of a large (070) & superbore (088) aspiration catheter to enhance trackability & simplify neuro-interventional procedures for faster as well as more efficient stroke treatment. Zipline also optimizes clot removal & improves success rates…

ByRidhi RastogiMarch 17, 2025

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The US FDA Grants 510(k) Clearance to Zimmer Biomet’s Persona Revision SoluTion Femur

Shots:The US FDA has granted 510(k) clearance to Persona Revision SoluTion Femur as an alternative for knee implant in pts with metal sensitivities; commercially available in the US in Q3’25 SoluTion Femur, part of the Persona Revision Knee System, utilizes surface-hardening treatment for enhanced wear performance & provides surgeons with anatomic components, incl.…

ByRidhi RastogiMarch 10, 2025

NEWS

Visby Medical Reports the US FDA Clearance and CLIA Waiver for Point-of-Care Respiratory Health Test

Shots:The US FDA granted 510(k) clearance (previously granted with EUA in Dec’22) and CLIA waiver for point-of-care respiratory health test. The Visby Medical Respiratory Health Test is a rapid PCR test used to detect and differentiate between upper respiratory infections caused by influenza (Flu) A & B and SARS-CoV-2 (COVID-19) Under the…

ByRidhi RastogiFebruary 28, 2025

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

CIRCA Scientific Reports the US FDA’s 510(k) Clearance of PeriCross Epicardial Access Kit for Controlled Pericardial Space Access

Ceribell’s Clarity Algorithm Receives the US FDA’s 510(k) Clearance to Detect Electrographic Seizures in Pediatric Patients

AliveDx Seeks the US FDA’s 510(k) Clearance for MosaiQ AiPlex Connective Tissue Diseases (CTDplus) Multiplex Microarray

The US FDA Grants 510(k) Clearance to Teleflex’s AC3 Range Intra-Aortic Balloon Pump (IABP) for Cardiac Patient Mobility

Huntleigh Healthcare Reports the US FDA’s 510(k) Clearance of Dawes-Redman CTG Analysis to Improve Non-Stress Test Interpretation in Fetuses

Perfuze Secures the US FDA’s 510(k) Clearance for its Zipline Access Catheters

The US FDA Grants 510(k) Clearance to Zimmer Biomet’s Persona Revision SoluTion Femur

Visby Medical Reports the US FDA Clearance and CLIA Waiver for Point-of-Care Respiratory Health Test

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