MRI2CT Secures FDA Clearance for AI-Powered NextMR Spine Imaging Platform

Shots: The US FDA has granted 510(k) clearance to NextMR, an AI-powered platform that generatesaccurate 3D bone visualization of the lumbar spine & sacrum directly from standarddiagnostic MRI scans NextMR works on MRI sequences acquired on 1.5T & 3T scanners, and generates 3D bone morphology in under 60sec., potentially reducing the need for additional imaging…

ByRidhi Rastogi4 days ago

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Click Therapeutics Receives 510(k) Clearance for Motivista to Treat Negative Schizophrenia Symptoms

Shots: FDA granted 510(k) clearance to Motivista (CT-155), a prescription digital therapeutic for treating negative symptoms of schizophrenia as an adjunct to clinician-managed outpatient care, incl. antipsychotic therapy, in pts (≥18yrs.) with clinically stable positive symptoms Clearance was supported by the P-III (CONVOKE) trial assessing CT-155 vs a digital control app in pts (≥18yrs.) with…

ByRidhi Rastogi5 days ago

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Ceribell Secures FDA Clearance for Quantitative EEG Trending and Amplitude-Integrated EEG Analysis

Shots: The US FDA has granted 510(k) clearance to a new software for the Ceribell System that converts raw EEG information into simplified easy-to-read trends, helping clinicians monitor changes in brain activity The update adds Alpha-Delta Ratio & Relative Alpha trending for detecting early signs of brain distress & reduced blood flow in high-risk pts,…

ByRidhi RastogiOctober 1, 2026

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Aptitude Receives US FDA Clearance for Next-Generation Metrix COVID Test

Shots: The US FDA has granted 510(k) clearance to the next-generation Metrix COVID Test, with development supported by BARDA. The test is cleared for OTC and professional use in CLIA-waived settings The handheld molecular test delivers approximately 3-fold higher analytical sensitivity & 30% faster results than EUA-authorized product, targeting urgent care & other decentralized settings Aptitude…

ByRidhi RastogiSeptember 17, 2026

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Emboline Receives US FDA 510(k) Clearance for Emboliner Embolic Protection System

Shots: FDA has granted 510(k) clearance to Emboliner Embolic Protection System for use as an embolic protection device to capture & remove embolic material during transcatheter aortic valve replacement (TAVR), with phased commercial launch to begin later this year Clearance was backed by extensive clinical data, incl. the PROTECT H2H IDE study assessing Emboliner vs. Sentinel Cerebral…

ByRidhi RastogiSeptember 10, 2026

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Heartvue.ai and Innolitics Receive FDA 510(k) Clearance for Heartvue.Proton

Shots: The US FDA has granted 510(k) clearance (K260811) to Heartvue.Proton, a machine learning-powered platform for viewing, post-processing & quantitative evaluation of cardiovascular MR images The platform automates 2D linear dimensions, ventricular volumes & ejection fraction, and blood flow quantification, while keeping results under physician review. It integrates with hospital PACS & EHR systems to…

ByRidhi RastogiSeptember 3, 2026

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Medibyt Receives FDA 510(k) Clearance for CPETWise

Shots: The US FDA has granted 510(k) clearance to CPETWise (K260242) designed to streamline cardiopulmonary exercise testing (CPET) analysis, interpretation and reporting through a standardized clinical workflow The clearance follows a 100-case proof-of-concept study at the University of Washington, where CPETWise achieved an average user satisfaction score of 4.5/5 & cut interpretation time by more…

ByRidhi RastogiSeptember 2, 2026

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Tempus AI Secures FDA Clearance for AI-Enabled Pulmonary Hypertension ECG Tool

Shots: Tempus AI has received FDA 510(k) clearance for Tempus ECG-PH, an AI-enabled software device that analyzes standard 12-lead ECGs for signs associated with pulmonary hypertension (PH) Designed for patients aged 40 and older with cardiovascular symptoms but no known PH history, Tempus ECG-PH identifies ECG patterns associated with elevated mean pulmonary artery pressure Tempus…

ByRidhi RastogiAugust 25, 2026

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Vesalio Receives FDA 510(k) Clearance for pVasc NET Peripheral Thrombectomy Device

Shots: Vesalio has received the US FDA 510(k) clearance for pVasc NET, a next-generation peripheral mechanical thrombectomy device with an integrated distal filter pVasc NET builds on the pVasc platform, a self-expanding nitinol device delivered through a low-profile catheter for non-surgical removal of emboli & thrombi from peripheral blood vessels pVasc NET features a fine-pore,…

ByRidhi RastogiAugust 14, 2026

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Elevation Spine Receives FDA Clearance for Saber-XA ALIF System

Shots: The US FDA has granted 510(k) clearance to Saber-XA, an anterior lumbar interbody fusion (ALIF) system combining an expandable cage with a zero-profile anterior lumbar plate, enabling intra-operative customization of implant height & lordosis Saber-XA allows surgeons to independently adjust implant height & lordotic angle based on patient anatomy, with multiple configurations across its…

ByRidhi RastogiAugust 12, 2026

MRI2CT Secures FDA Clearance for AI-Powered NextMR Spine Imaging Platform

Click Therapeutics Receives 510(k) Clearance for Motivista to Treat Negative Schizophrenia Symptoms

Aptitude Receives US FDA Clearance for Next-Generation Metrix COVID Test

Emboline Receives US FDA 510(k) Clearance for Emboliner Embolic Protection System

Heartvue.ai and Innolitics Receive FDA 510(k) Clearance for Heartvue.Proton

Medibyt Receives FDA 510(k) Clearance for CPETWise

Tempus AI Secures FDA Clearance for AI-Enabled Pulmonary Hypertension ECG Tool

Vesalio Receives FDA 510(k) Clearance for pVasc NET Peripheral Thrombectomy Device

Elevation Spine Receives FDA Clearance for Saber-XA ALIF System

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