Press Room
Explore the latest updates, client wins, and industry news from Grand Avenue Software.
June 23, 2025
Ancora Heart reaches enrollment milestone in pivotal heart failure device trial
We’re excited to share Ancora Heart, Inc. has reached full enrollment in its pivotal heart failure device trial.
Hitting this enrollment goal underscores the promise of their innovative ventricular assist technology—and brings them one step closer to delivering life-changing solutions for patients with advanced heart failure.
By leveraging Grand Avenue Software’s eQMS to streamline document control, training, and compliance, Ancora Heart’s team can focus on executing the trial and accelerating patient access to their breakthrough therapy.
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June 23, 2025
NeuroOne® patient surpasses one year milestone of seizure freedom following treatment with OneRF® Ablation System
We’re proud to see our customers delivering real-life impact.
NeuroOne Medical Technologies Corporation (NASDAQ: NMTC) ‘s OneRF Ablation System has now helped a patient achieve over one year of seizure freedom, a remarkable milestone in epilepsy care.
With Grand Avenue Software managing their quality and compliance workflows, NeuroOne can concentrate on refining their innovative ablation technology and supporting more patients on their journey to lasting relief.
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June 18, 2025
FDA adds Gradient denervation tech to advisory program
We’re proud to see Gradient Denervation Technologies selected for the FDA’s first-ever Denervation Technology Advisory Program, a testament to their leadership in next-generation nerve ablation therapies.
Gradient’s participation will help define best practices and regulatory pathways for this emerging class of devices. Behind the scenes, they’ve relied on Grand Avenue Software to streamline their quality processes—from design control and risk management to document tracking—so they can focus on innovation with confidence.
Congratulations to the Gradient Bio team on this milestone. We’re honored to support your journey toward safer, more effective denervation treatments.
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June 3, 2025
FastWave Medical announces successful first-in-human procedures in study of Sola™, its next-generation coronary laser IVL system
FastWave Medical has successfully completed the first-in-human procedures in their SOLA™ next-generation coronary laser IVL study, demonstrating safety and feasibility in treating calcified lesions.
We’re excited to support FastWave’s pioneering clinical work with the quality systems that keep innovation moving forward.
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May 15, 2025
Elucent Medical wins FDA breakthrough nod for in-body spatial intelligence system
Another step forward for non-invasive treatment.
HistoSonics, Inc. just secured a national reimbursement code for its groundbreaking histotripsy platform, paving the way for broader patient access and hospital adoption of non-invasive liver tumor treatment.
We’re proud to support forward-thinking teams like HistoSonics with the quality infrastructure they need to scale responsibly. Whether it’s clinical trial support or commercialization readiness, Grand Avenue Software helps simplify compliance while accelerating progress.
Congratulations to the entire HistoSonics team on this important milestone!
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May 12, 2025
HistoSonics earns first major reimbursement win for non-invasive histotripsy
Another step forward for non-invasive treatment.
HistoSonics, Inc. just secured a national reimbursement code for its groundbreaking histotripsy platform, paving the way for broader patient access and hospital adoption of non-invasive liver tumor treatment.
We’re proud to support forward-thinking teams like HistoSonics with the quality infrastructure they need to scale responsibly. Whether it’s clinical trial support or commercialization readiness, Grand Avenue Software helps simplify compliance while accelerating progress.
Congratulations to the entire HistoSonics team on this important milestone!
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May 8, 2025
MicroTransponder has positive results for its stroke-recovery neurostim
Another exciting step forward in neurostimulation!
MicroTransponder recently announced positive results from its clinical trial evaluating the Vivistim® Paired VNS™ System—designed to improve upper limb mobility in stroke survivors through targeted neurostimulation and rehabilitation.
At Grand Avenue Software, we’re proud to support innovative companies like MicroTransponder as they bring life-changing medical technologies to market. From development through post-market compliance, our flexible quality system helps streamline operations and support clinical excellence.
Congratulations to the MicroTransponder team on this milestone!
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May 7, 2025
FastWave Medical earns nod to begin IVL feasibility study
We’re proud to support innovators like FastWave Medical, who are shaping the future of intravascular lithotripsy (IVL) for calcified coronary artery disease. The results from their first-in-human feasibility study of the NOD™ IVL System show strong early safety and efficacy—an exciting step forward in cardiovascular intervention.
At Grand Avenue Software, we build tools that help medical device teams focus on what matters most: breakthrough science, safe outcomes, and scalable compliance.
Thank you to the FastWave team for trusting us on the journey!
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May 3, 2025
Endogenex says ReCET system study shows promise for type 2 diabetes patients
Endogenex recently announced new findings from the ReCET™ clinical study, showing promising progress in treating Type 2 diabetes through targeted duodenal mucosal resurfacing.
With their ReCET system entering its pivotal ReCET-02 trial, Endogenex is at the forefront of innovation in metabolic disease treatment. We’re proud to support their clinical and quality operations with Grand Avenue Software as they move closer to regulatory milestones and broader impact.
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April 28, 2025
HistoSonics’ Histotripsy System Demonstrates 90% Local Tumor Control at 12 Months in #HOPE4LIVER Trials
Congratulations to HistoSonics, Inc. on a major clinical achievement. New data from the HOPE4LIVER trials show their histotripsy system delivered a 90% local tumor control rate at 12 months for patients with primary and metastatic liver tumors.
This non-invasive, non-thermal technology uses focused sound energy to precisely destroy targeted tissue, offering a breakthrough option for patients who have limited treatment choices.
Another exciting step forward in advancing image-guided therapy. We’re proud to support innovators like HistoSonics as they continue to push the boundaries of patient care.
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April 25, 2025
Cordis shares positive study results from multiple drug-eluting balloon studies
Congratulations to Cordis for the impressive results across three clinical studies evaluating their SELUTION SLR drug-eluting balloon technology.
The findings showed strong safety and effectiveness across a range of cardiovascular applications, reinforcing Cordis’ commitment to innovation in minimally invasive vascular therapies.
We’re proud to support companies like Cordis as they continue to drive advancements in patient care.
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April 24, 2025
Field Medical raises $40M Series A for pulsed field ablation tech
Congrats to the Field Medical team on raising $40M to advance their pulsed field ablation (PFA) platform for cardiac arrhythmias.
This funding round will accelerate clinical programs and fuel development of Field’s proprietary PFA technology—bringing safer, more efficient cardiac ablation closer to reality.
We’re proud to support pioneers like Field Medical as they scale transformative medtech solutions. Exciting days ahead!
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April 18, 2025
Solo Pace wins FDA clearance for temporary pacing during TAVR
Congratulations to the SoloPace team on receiving FDA 510(k) clearance for their innovative temporary pacing system used during TAVR procedures.
This clearance marks a step forward in simplifying cardiac pacing during structural heart interventions — and we’re honored to support SoloPace in their journey.
From early development through regulatory submission, SoloPace leveraged Grand Avenue Software to manage design controls, risk, and quality documentation in a single, centralized system.
Here’s to the innovators pushing healthcare forward — one approval at a time.
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April 11, 2025
Innoblative wins FDA IDE for electrosurgical device for breast cancer treatment
Big congratulations to Innoblative on receiving FDA Investigational Device Exemption (IDE) approval for their groundbreaking electrosurgical device for breast cancer treatment.
Their innovative approach to improving breast-conserving surgery represents a major step forward in patient care, and we’re honored to support quality and compliance behind the scenes.
We’re proud to partner with teams like Innoblative—advancing the future of medtech one milestone at a time.
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