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NEWS

KORU Medical Systems Seeks FDA Clearance for FreedomEDGE System to Deliver Phesgo in HER2+ Breast Cancer Patients

Shots: The US FDA has received the 510(k) premarket notification for FreedomEDGE infusion system to subcutaneously administer Phesgo (Perjeta/Herceptin/hyaluronidase-zzxf) in HER2+ breast cancer The Infusion System enables efficient large-volume SC drug delivery, addressing unmet needs in oncology infusion centers by improving nurse administration experience while supporting faster, more streamlined clinical workflows The system supports SC…
December 31, 2025

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NEWS

StimLabs Reports the US FDA 510(k) Clearance of Theracor for Acute and Chronic Wound Management

Shots: The FDA has granted 510(k) clearance to Theracor, a human umbilical cord-derived medical device offered in sheet form, for wound care Indicated for the same wound types as StimLabs’ Corplex P, Theracor is used for partial & full-thickness wounds, pressure, venous, diabetic, & chronic vascular ulcers, tunneled/undermined wounds, surgical sites, trauma-related injuries, & draining…
December 30, 2025

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Abbott
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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…
December 19, 2025

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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…
December 18, 2025

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NEWS

Lumos Labs Reports the US FDA Clearance of LumosityRx for ADHD Patients

Shots: The US FDA has granted 510(k) clearance to LumosityRx, a prescription digital therapeutic, designed to improve attention in adults (22-55yrs.) with attention deficit hyperactivity disorder (ADHD) Assessed in the GAMES Study (n>500), LumosityRx showed significantly improved TOVA Attention Comparison Score (1EP) vs a control app, with 44.2% pts achieving clinically meaningful attention gains (>1.4 points…
December 11, 2025

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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…
December 3, 2025

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Roche
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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…
December 2, 2025

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GE HealthCare Seeks the US FDA 510(k) Clearance for SIGNA MRI technology to Advance Precision Diagnostics

Shots: The US FDA has received 510(k) submissions for SIGNA MRI technology, unveiled at RSNA 2025, to enhance diagnostics with advanced imaging innovations SIGNA Bolt focuses on high-performance 3.0T imaging with ultra-high gradients, AI-enabled workflows, & research-grade flexibility, while SIGNA Sprint with Freelium emphasizes accessibility through a helium-minimal (<1% helium usage) ventless 1.5T system designed for installation…
December 1, 2025

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NEWS

Transmural Systems Receives the US FDA 510(k) Clearance for TELLTALE to Prevent Coronary Obstruction During TAVR

Shots: The US FDA has granted 510(k) clearance to TELLTALE for the prevention of coronary obstruction in pts undergoing Transcatheter Aortic Valve Replacement (TAVR) for both native aortic stenosis & bioprosthetic valve failure FDA cleared TELLTALE following a pivotal study demonstrating the device’s safety & effectiveness for leaflet modification in pts at risk of coronary…
November 24, 2025

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