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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…
July 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…
July 16, 2026

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Universal Brain Reports FDA Clearance of UB ERP System for Rapid Brain-Function Measurement

Shots: The US FDA granted 510(k) clearance to the UB ERP System for electroencephalography & event-related potentials-based brain function assessment, with commercial launch expected later this year To support clinical expansion, the company initiated US & Japan studies in depression to evaluate brain function before & after 1L antidepressant treatment, and develop objective brain function…
July 14, 2026

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iHealthScreen Reports FDA Clearance of iPredict-DR for Diabetic Retinopathy Screening

Shots: The US FDA has granted 510(k) clearance to iPredict-DR, an AI-powered software that automatically detects more than mild diabetic retinopathy (mtmDR) in adults with diabetes who have not been previously diagnosed iPredict-DR uses AI to analyze retinal fundus images from the iCare DRSplus camera for non-invasive & affordable diabetic retinopathy screening, with clearance backed…
July 9, 2026

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Xenix Medical Reports the US FDA Clearance for Lux Expandable Lumbar Fusion System

Shots: Xenix Medical has received the US FDA 510(k) clearance & initiated the full commercial launch of its Lux Expandable Lumbar Interbody Fusion System Lux features up to 4.5mm of controlled post-implant expansion, enables bone graft delivery through the inserter into a large endplate-to-endplate graft window after expansion, & incorporates NanoACTIV surface tech. to support fusion…
June 9, 2026

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Protaryx Medical Secures FDA Clearance for its Transseptal Access Device

Shots: The US FDA has granted 510(k) clearance to the Transseptal Puncture Device to advance minimally invasive access for left-heart procedures, with plans to begin US commercialization  The Device is a next-gen system enabling zero-exchange access to the left heart, integrating RF guidewire tech with standard electrosurgical generators & an echogenic, extendable atraumatic probe to…
April 14, 2026

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Anumana Secures the US FDA 510(k) Clearance for its ECG-AI Algorithm to Detect Risk of Cardiac Amyloidosis Early

Shots: The US FDA has granted clearance to ECG-AI algorithm, a software-as-a-medical-device designed for cardiac amyloidosis (CA), cleared for use with standard 12-lead ECGs ECG-AI algorithm analyzes ECG waveforms to detect CA-related patterns not visible to clinicians, integrating into existing workflows using routine ECGs without additional testing to help identify at-risk pts & guide next…
April 9, 2026

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Zeto Receives US FDA 510(k) Clearance for Zeto New Wave to Advance Outpatient EEG

Shots: The US FDA has granted 510(k) clearance to Zeto New Wave to perform EEG efficiently in outpatient clinics & homes Zeto New Wave is an easy-to-use outpatient EEG system with 21 soft-tip electrodes (10–20 system), offering full head coverage & paired with a compact device capturing synchronized video/audio  Designed for short-term recordings up to 2.5hrs., the…
April 3, 2026

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Anumana Secures the US FDA 510(k) Clearance for its ECG-AI Algorithm to Detect Pulmonary Hypertension Early

Shots: The FDA has granted 510(k) clearance to an AI-enabled PH algorithm, a software-as-a-medical-device designed to detect early signs of PH, cleared for use with standard 12-lead ECGs The PH algorithm detects subtle early PH patterns in standard 12-lead ECGs & integrates with EHR & ECG management systems, plus it operates entirely within the health…
March 30, 2026

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Prodeon Medical Secures FDA Clearance for Urocross Expander System to Treat Urinary Symptoms Associated with BPH

Shots: The US FDA has granted 510(k) clearance to the Urocross Expander System for the treatment of lower urinary tract symptoms associated with benign prostatic hyperplasia (BPH), backed by extensive data incl. the Expander-1 & Expander-2 trials Expander-2 (n=240) showed mean 48.1% IPSS improvement & a 74.5% responder rate (≥30% IPSS reduction) at 12mos. post implantation…
March 17, 2026

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