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Bruno Vision Care

Bruno Vision Care Reports the US FDA Clearance of Deseyne for Presbyopia

Shots: FDA has cleared Deseyne, a daily disposable soft contact lens for presbyopia that uses patented Extended Depth of Focus technology Deseyne provides continuous near, intermediate, & distance vision through Cataltheia’s patented hyper-refractive central zone, showing a clinical advantage over multifocal lenses with minimal patient adaptation, strong comfort, & no adverse events reported in studies Made…

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Pulse Biosciences Receives the US FDA IDE Approval to Initiate Study for nsPFA System in Paroxysmal Atrial Fibrillation (PAF)

Shots: The US FDA has granted IDE approval to initiate the NANOPULSE-AF study of Pulse's nsPFA Cardiac Catheter System for the treatment of PAF The study will assess the primary safety and efficacy of the nsPFA Cardiac Catheter System in ~145 pts for the treatment of drug-resistant symptomatic PAF across 30 sites, incl. 3 outside…

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Abbott

Abbott Reports FDA Clearance and CE Mark Approval of its Amplatzer Piccolo Delivery System for Premature Babies with a Hole in the Heart

Shots: Abbott has received the US FDA clearance & European CE Mark for its Amplatzer Piccolo Delivery System, used with Amplatzer Piccolo Occluder, to treat premature babies (≥2lbs) with patent ductus arteriosus (PDA; hole in the heart) Approved in the US & EU in 2019, Amplatzer Piccolo Occluder is a minimally invasive transcatheter device, smaller…

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SleepRes’ Kricket PAP Device Receives the US FDA 510(k) Clearance for Obstructive Sleep Apnea

Shots: The US FDA has granted 510(k) clearance to the Kricket PAP device, powered by Kairos Positive Airway Pressure (KPAP), for the treatment of OSA pts (>66lbs) Kricket PAP device uses KPAP tech to dynamically adjust pressure with each breath, synchronizing with pts’ natural respiration to reduce unnecessary pressure, improve comfort & tolerance, & offering…

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Zenflow Receives the US FDA Approval for Zenflow Spring Implant and Delivery System for Benign Prostatic Hyperplasia (BPH)

Shots: The US FDA has approved Zenflow Spring Implant & Delivery System, a first-line interventional therapy, for the treatment of BPH-associated symptoms Assessed in the BREEZE study, the system met all 1 & 2EPs, showing a 60% responder rate vs 33% for sham & a 37% IPSS improvement exceeding the 30% success threshold at 1yr.,…

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Resmed Receives FDA Clearance for Smart Comfort, an AI-Enabled Tool to Personalize CPAP Therapy

Shots: Resmed received FDA clearance for its AI-enabled Smart Comfort for PTCS (Personalized Therapy Comfort Settings), the first FDA-cleared device for personalized comfort settings for obstructive sleep apnea (OSA) pts start and stay on CPAP therapy US rollout begins in limited beta versions for new users of myAir users in early 2026, followed by broader availability…

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Cardiawave Receives CE Mark for Valvosoft to Treat Severe Symptomatic Aortic Stenosis  

Shots: Cardiawave has received the European CE Mark for its Valvosoft to treat Severe Symptomatic Aortic Stenosis (sSAS) Valvosoft delivers precise high-intensity ultrasound that induces non-thermal, mechanical energy to soften aortic valve leaflets tissues, restoring their mobility & improving anatomical & hemodynamic function Valvosoft was evaluated in the Valvosoft FIM Study (24mos.) & Pivotal Study…

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Medtronic Receives the US FDA clearance for Hugo RAS system for Urologic Surgical Procedures

Shots: The US FDA has granted clearance to Hugo robotic-assisted surgery (RAS) system for use in minimally invasive urologic surgical procedures, incl. prostatectomy, nephrectomy, & cystectomy The Hugo RAS system met its primary safety & efficacy endpoints in the Expand URO IDE study, showing performance in urologic procedures consistent with outcomes reported in published literature…

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