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…

ByRidhi RastogiDecember 19, 2025

NEWS

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…

ByRidhi RastogiDecember 18, 2025

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May Health’s Anavi System Receives the European CE Mark for Women with PCOS-Related Infertility

Shots: May Health has received CE Mark for its Anavi System to treat PCOS-related infertility based on EU & US ULTRA studies in anovulatory or oligo-ovulatory women with PCOS who failed, declined, or were contraindicated to 1L therapy At 12mos. (26 evaluable pts/32), 77% (20/26) ovulated (13 spontaneously & 7 after restarting 1L therapy), with…

ByRidhi RastogiDecember 17, 2025

NEWS

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.,…

ByRidhi RastogiDecember 12, 2025

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ProVerum Receives the US FDA Approval for ProVee System to Treat Benign Prostatic Hyperplasia

Shots: The US FDA has approved ProVee System for the treatment of benign prostatic hyperplasia (BPH) Approval was backed by the ProVIDE study assessing ProVee in men, which met its 1 & 2EPs, showing significant & durable symptom relief as well as improved urinary flow through 12mos. compared to sham, with preserved sexual function &…

ByRidhi RastogiDecember 10, 2025

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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…

ByPrince GiriDecember 9, 2025

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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…

ByRidhi RastogiDecember 5, 2025

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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…

ByRidhi RastogiDecember 4, 2025

NEWS

Francis Medical’s Vanquish Water Vapor System Receives the US FDA 510(k) Clearance for Prostate Tissue Ablation

Shots: FDA has granted 510(k) clearance to Vanquish Water Vapor System for prostate tissue ablation in pts with intermediate-risk, localized prostate cancer Clearance was supported by 12mos. follow-up data on 110 pts first enrolled in the ongoing VAPOR 2 trial (n=235) assessing Vanquish System across the US, with longer-term to support PMA submission 6mos. biopsy…

ByRidhi RastogiDecember 3, 2025

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Roche’s Point-of-Care PCR Test Gains FDA’s 510(k) Clearance with CLIA Waiver and European CE Mark to Diagnose Bordetella infections

Shots: Roche has received 510(k) clearance with CLIA waiver & CE-IVDR certification for its point-of-care test to diagnose whooping cough (pertussis) & other Bordetella infections The PCR test on the cobas liat system delivers results in 15min. in GP clinics & emergency rooms, allowing real-time diagnosis during consultation & supporting immediate antibiotic decisions to help…

ByRidhi RastogiDecember 2, 2025

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

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

May Health’s Anavi System Receives the European CE Mark for Women with PCOS-Related Infertility

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

ProVerum Receives the US FDA Approval for ProVee System to Treat Benign Prostatic Hyperplasia

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

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

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

Francis Medical’s Vanquish Water Vapor System Receives the US FDA 510(k) Clearance for Prostate Tissue Ablation

Roche’s Point-of-Care PCR Test Gains FDA’s 510(k) Clearance with CLIA Waiver and European CE Mark to Diagnose Bordetella infections

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