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Stryker

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 painOptaBlate BVN achieves ≥1cm lesions in 7min. & features a steerable curved introducer, with microinfusion tech to minimize impedance & charring, plus 10-gauge access tools for precisionOptaBlate BVN combines…

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Teleflex

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…

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Circa Scientific

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,…

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Ceribell

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 &…

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AliveDx

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,…

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Teleflex

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…

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Huntleigh

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…

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Zimmer Biomet

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.…

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