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

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Bracco Imaging Secures FDA and Health Canada Clearances for VueJect

Shots: Bracco Imaging has received the US FDA 510(k) clearance & Health Canada authorization for VueJect, its dedicated ultrasound contrast delivery system designed specifically for cardiology imaging VueJect is designed to improve workflow efficiency, reduce operator variability & enable continuous administration of ultrasound contrast agents for more consistent enhancement during cardiac imaging VueJect will initially…

ByRidhi RastogiAugust 12, 2026

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Ceribell Secures FDA Clearance for AI-Powered EEG Enhancements

Shots: The US FDA has granted 510(k) clearance to two AI algorithm enhancements, Epileptiform Abnormality Detection & Artifact Reduction, which are integrated into its cloud-based Neurology Portal The Artifact Reduction algorithm identifies interference from patient movement, medical equipment, and physiological signals, while Epileptiform Abnormality Detection flags abnormal patterns across lengthy EEG recordings, helping neurologists navigate…

ByRidhi RastogiAugust 11, 2026

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BlueWind Medical Receives FDA Clearance for Revi Extend Implant

Shots: The US FDA has granted 510(k) clearance to Revi Extend, the next-generation implant for Revi System to treat urgency urinary incontinence (UUI), with the new implant offering an extended lifespan of 15yrs.Limited US launch planned for Q4’26 Built on Implantable Tibial Neuromodulation (ITNM), Revi System is designed to reduce the long-term treatment burden through…

ByRidhi RastogiAugust 6, 2026

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Sight Sciences’ OMNI Ultra Surgical System Secures the US FDA 510(k) Clearance

Shots: The US FDA has granted 510(k) clearance to the OMNI Ultra Surgical System for canaloplasty followed by trabeculotomy for the reduction of intraocular pressure (IOP) in adults with primary open-angle glaucoma (POAG) The OMNI platform is backed by extensive clinical evidence showing sustained IOP reduction and reduced medication use, with the OMNI Ultra remaining on…

ByRidhi RastogiAugust 5, 2026

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Elevation Spine Receives US FDA Clearance for Saber-C AVIA

Shots: The US FDA has granted 510(k) clearance to Saber-C AVIA, a zero-profile ACDF system featuring a porous 3D-printed titanium interbody with spike & screw fixation options Saber-C AVIA is designed to deliver the biomechanical stability of traditional plating in a lower-profile implant, featuring updated spike delivery tools, low-profile screw instruments, and a single-tray system…

ByRidhi RastogiJuly 29, 2026

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HoneyNaps Secures FDA Clearance for AI Sleep Diagnostic Software Somnum V3.0

Shots: The US FDA has granted 510(k) clearance to Somnum V3.0, an AI-based clinical decision support software to assist medical professionals in analyzing polysomnography data, incl. sleep staging & respiratory event detection Somnum V3.0 automatically detects apnea & hypopnea events, & classifies them as obstructive, central, or mixed sleep apnea. Validation data submitted to the…

ByRidhi RastogiJuly 16, 2026

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ElectroWire Medical Secures FDA 510(k) Clearance for LightningWire Transseptal System

Shots: The US FDA has granted 510(k) clearance to the LightningWire Transseptal Puncture System, indicated to create an atrial septal defect to enable the introduction of cardiovascular catheters LightningWire combines an electrosurgical guidewire & activation cable for transseptal access, working with preferred introducers & existing electrosurgical generators. Its insulation enables low-power puncture, while the 0.032-inch…

ByRidhi RastogiJuly 16, 2026

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

Bracco Imaging Secures FDA and Health Canada Clearances for VueJect

Ceribell Secures FDA Clearance for AI-Powered EEG Enhancements

BlueWind Medical Receives FDA Clearance for Revi Extend Implant

Sight Sciences’ OMNI Ultra Surgical System Secures the US FDA 510(k) Clearance

Elevation Spine Receives US FDA Clearance for Saber-C AVIA

HoneyNaps Secures FDA Clearance for AI Sleep Diagnostic Software Somnum V3.0

ElectroWire Medical Secures FDA 510(k) Clearance for LightningWire Transseptal System

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