Navi Medical Technologies Receives the US FDA’s 510(k) Clearance for Neonav ECG Tip Location System

Shots: Navi Medical has reported the US FDA’s 510(k) clearance for Neonav ECG Tip Location System to improve pediatric vascular care, with plans to raise capital & engage hospitals to expand access in the US market The system uses real-time ECG analysis to facilitate CVAD placement in pediatric pts, reducing misplacement & migration risks…

ByRidhi RastogiFebruary 17, 2025

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AliveDx Seeks US FDA’s 510(k) Clearance for MosaiQ AiPlex Multiplex Microarray

Shots: The US FDA has received 510(k) Application for MosaiQ AiPlex Multiplex Microarray to improve & accelerate diagnosis of celiac disease MosaiQ simplifies serological evaluation with syndromic approach by combining IgA & IgG isotypes to detect IgA deficiency & measure anti-tTG as well as anti-DGP (AU/mL) using just 20 μL of sample in single…

ByRidhi RastogiFebruary 10, 2025

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Gyder Surgical Reports the US FDA’s 510(k) Clearance for Gyder Hip System

Shots: The US FDA has granted 510(k) clearance to the Gyder Hip System for positioning of the acetabular cup during anterior hip arthroplasty following approval from Australia’s TGA Gyder Hip System eliminates the use of metallic pins & pre-operative/intra-operative imaging for landmark registration, offering a less invasive approach than conventional hip navigation System features 1min…

ByRidhi RastogiFebruary 5, 2025

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Life Spine Receives US FDA’s 510(k) Clearance for ProLift Pivot Expandable Spacer System

Shots: The US FDA has granted 510(k) clearance to Prolift Pivot expandable spacer system, expanding Life Spine’s Micro Invasive tech portfolio The system provides full articulation for precise spinal fusion, while reducing tissue disruption & nerve retraction, allowing surgeons to restore patient alignment with superior control & efficiency. It also features OSSEO-LOC surface tech that promotes osseointegration & long-term…

ByDipanshu DixitJanuary 30, 2025

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ClearPoint Neuro Receives US FDA’s 510(k) clearance for ClearPoint Navigation Software Version 3.0

Shots: The US FDA has granted 510(k) clearance to ClearPoint Navigation Software 3.0 that will introduce intraoperative CT workflow, expanding its use from MRI. The company is planning to initiate limited market release in Q1’25 & full release in H2’25 Navigation Software 3.0 is compatible with intraoperative CT & Conebeam CT imaging, enabling precision neurosurgery in facilities…

ByRidhi RastogiJanuary 28, 2025

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Roche Receives 510(k) Clearance & CLIA Waiver for Cobas Liat Multiplex Assay Panels to Diagnose Sexually Transmitted Infections

Shots: The US FDA has granted 510(k) clearance & CLIA waiver for Cobas liat STI multiplex assay panels (CT/NG & CT/NG/MG), commercially available under the CE mark in upcoming months The CT/NG (chlamydia & gonorrhea) & CT/NG/MG (chlamydia, gonorrhea & Mycoplasma genitalium) assays compliment the existing portfolio of singleplex & multiplex tests of Cobas liat…

ByRidhi RastogiJanuary 22, 2025

Navi Medical Technologies Receives the US FDA’s 510(k) Clearance for Neonav ECG Tip Location System

AliveDx Seeks US FDA’s 510(k) Clearance for MosaiQ AiPlex Multiplex Microarray

Gyder Surgical Reports the US FDA’s 510(k) Clearance for Gyder Hip System

Life Spine Receives US FDA’s 510(k) Clearance for ProLift Pivot Expandable Spacer System

ClearPoint Neuro Receives US FDA’s 510(k) clearance for ClearPoint Navigation Software Version 3.0

Roche Receives 510(k) Clearance & CLIA Waiver for Cobas Liat Multiplex Assay Panels to Diagnose Sexually Transmitted Infections

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