Fogarty Innovation

10/31/2025

The Fogarty team came out swinging last week for the 29th Annual El Camino Health Heritage Golf Tournament. All proceeds supported the expansion of the oncology service line at El Camino Health's Los Gatos campus. We hated missing work that day, but felt it was important to do our part. 😃

p.s. Denise Demarais we missed you!

10/31/2025

With over 100 patents and decades of experience in medtech innovation, Fogarty Innovation engineer-in-residence Bernie Andreas brings unmatched technical insight, a team approach, and a signature dose of dry humor to every startup he mentors. From shaping early-stage prototypes to guiding FDA submissions, Bernie’s blend of curiosity, collaboration, and creativity helps founders turn breakthrough ideas into reality.

Read how Bernie’s mentorship continues to shape the next generation of medtech innovators. https://www.fogartyinnovation.org/bernie-andreas-engineering-expertise-meets-startup-spirit/

10/27/2025

Live from the main stage at , we were thrilled to announce that Fogarty Innovation and the Cardiovascular Research Foundation are officially merging in a strategic partnership that strengthens our shared mission and expands our impact.

Fogarty Innovation will continue its name and focus on coaching early-stage companies across clinical areas, educating stakeholders, and building alliances—now as CRF’s West Coast innovation hub—combining leadership, resources, and expertise to accelerate progress.

Stay tuned for what’s ahead. The future is brighter together! 🌟

Learn more: https://ow.ly/q2CM50XizFm

10/27/2025

10/25/2025

✨ Congratulations to the winners of the Inaugural Thomas J. Fogarty Innovation Prize ✨ We are thrilled to announce that Allan Zingeler, Raju Viswanathan, PhD, and Mike Mahoney of Boston Scientific have been awarded the inaugural Thomas J. Fogarty Innovation Prize for the FARAPULSE, Inc. Pulsed Field Ablation (PFA) System.

This transformative technology is redefining care for atrial fibrillation, the most common sustained cardiac arrhythmia affecting more than 10 million Americans. With its groundbreaking pulsed field ablation approach, FARAPULSE has already improved outcomes for more than half a million patients worldwide and has become one of the fastest-adopted technologies in medical device history.

At a gala dinner and award ceremony last night, we also honored the two other extraordinary finalists: John Adler, MD, for Frameless Stereotactic Radiosurgery, and Michael Harrison, MD, for pioneering the field of Fetal Surgery.

We’ll share more photos and details in the days to come. Thank you to our sponsors, selection committee, presenters, finalists, nominees, and inspiring community for an extraordinary night.

10/23/2025

🦈 Just when you thought investor pitches were routine…
The TCT Shark Tank Innovation Competition is back this Saturday, Oct. 25, at the TCT MedTech Innovation Forum in San Francisco. Six fearless finalists will take the plunge, pitching breakthrough ideas and competing for a $200,000 prize generously funded by the Jon DeHaan Foundation. Cue the music and grab your seat— you won't want to miss this!

Register: https://www.tctconference.com/medtech


Cardiovascular Research Foundation

10/17/2025

Matt Kaufman is usually the one asking the questions. As a senior partner at The Mullings Group and the host of The Family Business podcast, he’s spent more than two decades connecting with executives at a personal level to uncover what truly drives them. Recently, we turned the tables, and asked Matt to spill the tea - on his approach to recruiting, why chemistry and EQ matter more than meeting every requirement, when an interview really ends (hint: it's later than you think), and what it means to be a coach, on and off the field.

We had a fabulous time getting to know Matt, and we're grateful that The Mullings Group is helping the medtech industry thrive by building high-performing teams and guiding leaders into meaningful roles.

https://www.fogartyinnovation.org/matt-kaufman-a-coach-at-heart/

10/15/2025

“It doesn’t matter if my colon looks great if I can’t leave the house.”
That’s what patients living with inflammatory bowel disease (IBD) told Heather Simonsen, CEO of Fogarty company-in-residence, Boomerang Medical, when asked what matters most in their care.

Despite tremendous advances in IBD treatment, there remains a major gap: few solutions specifically address the day-to-day symptoms—urgency, unpredictability, lifestyle disruption—that define quality of life.

Boomerang’s pivotal BOOM-IBD2 trial, which is currently enrolling in medical centers across the US, is designed to change that. It is the first pivotal study of sacral neuromodulation in ulcerative colitis.

What's more, patients themselves shaped the trial design. Working in collaboration with the Crohn's & Colitis Foundation and a patient advisory group, Boomerang ensured the endpoints reflect what truly matters to the people living with the disease.

You can learn more about Boomerang Medical here: https://www.fogartyinnovation.org/boomerang-medical-advances-patient-centered-ibd-innovation-with-series-b-funding/

10/13/2025

💜 From heartbreak to hope: When Lydia lost much of her small intestine, her family feared the worst. But with courage, expert care at Stanford Medicine Children's Health and the compassionate use of the investigative Eclipse XL1 System from Fogarty company-in-residence, Eclipse Regenesis, Lydia and her family got a second chance. Read how every centimeter made the difference:

Stanford Dept. of Surgery

Lydia Garcia was in for a tough start. Before she was born, her parents, Noemi and Ellis Garcia, learned she had transposition of the great arteries (TGA), a serious congenital heart defect in which oxygen-rich blood is sent back to the lungs while oxygen-poor blood circulates through the body. Left...

10/11/2025

"The foundation of every successful partnership is not just shared vision, but shared values" – Unknown

"Fogarty Innovation was founded on the El Camino Health 18 years ago with the vision of pairing a nonprofit medtech incubator with a forward-thinking community hospital committed to shaping technologies that improve patient care. Since then, our organizations have worked together to advance healthcare delivery. Our location on the campus has enabled Fogarty startups to gain early input from clinicians, understand care pathways and workflows, and hone their clinical and economic value propositions. At the same time, we have provided El Camino Health with access to novel technologies, tailored educational programs, and clinical research activities that have helped strengthen its reputation as one of the most innovative community hospitals in the nation.

This collaboration has had a measurable impact. Together, we’ve helped launch numerous groundbreaking companies and technologies, including HeartFlow (coronary artery disease detection), Alydia Health (postpartum hemorrhage treatment), and UltraSight (AI-powered cardiac ultrasound). Most recently, we partnered to refine and advance the Flosonics FloPatch—a wireless, wearable Doppler ultrasound that monitors blood flow in real time to help clinicians manage IV fluid therapy early in critical illness. El Camino Health went on to become the first U.S. hospital to adopt this technology.

Building on this track record and fueled by our shared commitment to improving human health, we are working even more closely on new initiatives to drive clinical excellence, advance innovation, and support workforce development. You’ll soon see 'at El Camino Health' integrated into our logo—a visible reminder of a partnership that’s not only enduring, but accelerating."

The above is excerpted from Andrew Cleeland's CEO letter that opens our most recent monthly newsletter. If you'd like to receive our newsletter directly, you can sign up here: https://lnkd.in/gKXKUwSd

10/09/2025

Welcome! We are thrilled to announce that Matt Hillebrenner has joined Fogarty Innovation as Director of Government Affairs. His move follows 22 years at the FDA, where he most recently served as Deputy Director, Office of Product Evaluation and Quality in the Center for Devices and Radiological Health.

At Fogarty, Matt will be part of our senior coaching team, helping medtech startups and entrepreneurs better navigate the regulatory environment and engage more effectively with other government agencies including the USPTO, Centers for Medicare & Medicaid Services, and The National Institutes of Health. He will also collaborate with Marga Ortigas-Wedekind and her team to deliver educational programming that leverages his significant experience and provides an insider’s perspective.

Reflecting on the move, Matt shared, “At FDA, I worked with a remarkable team dedicated to improving patient care by helping deliver safe and effective new devices. I can’t imagine a better place to explore new ways to make a difference for patients than Fogarty Innovation, where people and mission—and how they combine to form culture—are paramount. I look forward to learning from such a talented group and using my experience to support the early stage medtech innovation ecosystem.”

Fogarty Innovation CEO Andrew Cleeland added, “Matt’s arrival further strengthens our deeply experienced coaching team. His unique perspective and decades of regulatory leadership will be invaluable to our community and to advancing our mission of improving patient care through medtech innovation.”

Welcome to the Fogarty Innovation family!