Houston medical device startup names new CEO

now at the helm

Houston-based Saranas has tapped a new leader amidst push to commercialize bleed detection technology. Photo via LinkedIn

Houston-based medical device company Saranas has tapped a veteran of the healthcare industry as its new CEO.

Mike MacKinnon most recently was president and partner at Madison Ventures +, a private equity firm based in Greenwood Village, Colorado. The firm invests in companies in healthcare, real estate, finance, and other sectors.

Before joining Madison Ventures +, MacKinnon was CEO of Zidan Medical, a startup focused on treatment of airway lesions in patients with early stage lung cancer. He served in that role from 2019 to 2023.

Earlier, he was CEO of ROX Medical, a medical device company specializing in minimally invasive vascular therapy for patients with uncontrolled high blood pressure. He held that role from 2018 to 2019. He previously worked at Philips North America, Volcano, AtheroMed, Hansen Medical, Access Closure, and FoxHollow Technologies.

In a news release, Dan Wolterman, chairman of Saranas’ board and former president and CEO of Memorial Hermann Health System, calls MacKinnon “an accomplished executive with an impressive record of bringing disruptive technology to market, guiding strategy, and driving significant growth.”

Now president and CEO of Nashua, New Hampshire-based medical device company Conformal Medical, James Reinstein was president and CEO of Saranas from 2020 to 2022. Prior to Reinstein, Zaffer Syed held that position from 2017 to 2020. He's still an adviser for the company and recently announced his role as entrepreneur in residence at the Texas Medical Center.

Saranas is working on commercializing its Early Bird Bleed Monitoring System, touted as the first and only system FDA-approved bleeding detection system for procedures involving blood vessels. It is designed to detect bleeds early, enabling physicians to reduce medical risks and potentially avoid costly medical problems.

“Bleeding remains a common issue during and after endovascular procedures and can result in life-threatening complications,” says MacKinnon.

Since being founded in 2013, Saranas has treated over 1,200 patients with its device and has received $29.2 million in funding, according to Crunchbase. This includes a $12.8 million Series B round that Saranas got in 2021 from Chicago-based Baird Capital and Austin-based S3 Ventures.

The Early Bird device was developed at Houston’s Texas Heart Institute. The FDA approved the device in 2019.

Saranas has enrolled its first patient in its clinical trials. Photo courtesy of Saranas

Houston med device company secures first patient for clinical trial

health care tech

The first patient has been enrolled in a nationwide clinical trial that will evaluate the safety of Houston-based Saranas’ device for early detection of bleeding during minimally invasive heart procedures.

The initial patient was enrolled earlier this month at Morristown Medical Center in Morristown, New Jersey. The trial will eventually enroll up to 265 patients across the U.S.

Saranas’ Early Bird Bleed Monitoring System aids the detection of bleeding during high-risk percutaneous coronary intervention (PCI) procedures using mechanical circulatory support (MCS). In the clinical trial, the MCS will be the Impella heart pump.

PCI refers to minimally invasive procedures for opening clogged coronary arteries. MCS boosts heart function when the organ can’t perform at its best. The trial will test the ability of the Early Bird Bleed Monitoring System to detect serious or potentially fatal bleeding.

“As the field of minimally invasive, catheter-based procedures continues to advance, patient safety is paramount,” Dr. Babar Basir, director of acute mechanical circulatory support at Detroit’s Henry Ford Health System and co-principal investigator of SAFE-MCS, says in a news release. “This study will collect comprehensive procedural data in patients undergoing PCI with MCS.”

The data then will be reviewed to determine how real-time monitoring of bleeding can improve a patient’s health, Basir says.

Dr. Philippe Généreux, co-director of the Structural Heart Program at Morristown Medical Center, is the other co-principal investigator for the clinical trial.

“SAFE-MCS is the first prospective trial focused exclusively on the impact of integrating bleed monitoring in large-bore access for high-risk protected PCI patients,” says James Reinstein, president and CEO of Saranas, a medical device startup.

About one-fifth of patients will experience bleeding complications during “large bore” blood vessel procedures such as percutaneous MCS, transcatheter aortic valve replacement, and endovascular aneurysm repair. The estimated cost of one bleeding complication during these large-bore procedures is $18,000, adding up to an annual cost of $729 million for health care providers.

The Early Bird Bleed Monitoring System is the first and only device approved by the U.S. Food and Drug Administration (FDA) for real-time monitoring of bleeding problems during endovascular procedures for repair of blood vessels.

Saranas’ collaborators in the clinical trial are Proxima Clinical Research, a Houston-based contract research organization, and South Korea’s CardioVascular Research Foundation. The Early Bird study is expected to be completed by January 2023.

Since being founded in 2013, Saranas has collected $31.5 million in funding. This includes a $12.8 million Series B round that Saranas received this summer from Chicago-based Baird Capital and Austin-based S3 Ventures.

The Early Bird device was developed at Houston’s Texas Heart Institute. The FDA approved the device in 2019.

This week's roundup of Houston innovators includes Amy Chronis of Deloitte, James Reinstein of Saranas, and Tatiana Fofanova of Koda Health. Courtesy photos

3 Houston innovators to know this week

who's who

Editor's note: In this week's roundup of Houston innovators to know, I'm introducing you to three local innovators across industries — from energy to health tech — recently making headlines in Houston innovation.


Amy Chronis, Houston managing partner of Deloitte LLP

The Houston location is one of six Greenhouses in the U.S. and one of 40 around the world. Photo courtesy Deloitte/AlexandersPortraits.com

Co-located with the company's downtown Houston headquarters, the 14,000-square-foot Deloitte Greenhouse is intended to help executives plant and foster new ways of thinking, working, and experimenting in the energy industry.

Amy Chronis, Houston managing partner, at Deloitte LLP, says that as the energy capital of the world, Houston is an ideal location for one of six Greenhouses in the U.S. and one of 40 around the world.

"The oil and gas industry is at a crossroads where business transformation is no longer an option," says Chronis. "We are providing a controlled, safe environment for companies to experiment and test various workforce, technology and market scenarios to help them right-size and future-proof their businesses in this rapidly changing landscape." Click here to read more.

James Reinstein, president and CEO of Saranas

James Reinstein joins the Houston Innovators Podcast to discuss what's next for growing medical device company, Saranas. Photo courtesy

When James Reinstein took the helm of Houston-based Saranas in March 2020, he was tasked with taking the medical device company through its series B funding round and into larger clinical trials. Navigating these tasks during a global pandemic wasn't part of the plan.

"There was just so much uncertainty," Reinstein says on this week's episode of the Houston Innovators Podcast. "All of the funds didn't know which end was up, what hospitals would be doing, what procedures were going to begin again."

Saranas received FDA approval and began its clinical trials for its Early Bird Bleed Monitoring System in 2019. The device is designed to detect and track bleeding complications related to endovascular procedures. These medical procedures treat problems, such as aneurysms, that affect blood vessels. Around 20 percent of patients suffer a bleeding complication during endovascular procedures. Click here to read more.

Tatiana Fofanova, co-founder and CEO of Koda Health

Koda Health, Houston, uses AI to help guide difficult conversations in health care, starting with end-of-life care planning. Image via LinkedIn

Founded by Tatiana Fofanova, Dr. Desh Mohan, and Katelin Cherry, Koda Health uses AI to help patients create advance medical care directives and documents—such as a living will—through an easy to use web-based interface.

The app then autogenerates legal and medical documents, which patients can notarize or electronically witness the forms through the app or on their own.

According to Fofanova, who earned her PhD in in Molecular Medicine at Baylor College of Medicine in Houston and now acts as the company's CEO, what historically has been a time consuming and expensive process, through Koda Health, takes an average of 17 minutes and is completely free of charge to the end user.

"We hope to reduce any outstanding barriers to access that might exist," Fofanova says. "It is very frequently the oldest and the poorest that are the highest utilizers of health care that don't have access to these solutions." Click here to read more.

James Reinstein joins the Houston Innovators Podcast to discuss what's next for growing medical device company, Saranas. Photo courtesy

Health tech executive leads Houston startup into its next generation following $12.8M series B

houston innovators podcast episode 103

When James Reinstein took the helm of Houston-based Saranas in March 2020, he was tasked with taking the medical device company through its series B funding round and into larger clinical trials. Navigating these tasks during a global pandemic wasn't part of the plan.

"There was just so much uncertainty," Reinstein says on this week's episode of the Houston Innovators Podcast. "All of the funds didn't know which end was up, what hospitals would be doing, what procedures were going to begin again."

Saranas received FDA approval and began its clinical trials for its Early Bird Bleed Monitoring System in 2019. The device is designed to detect and track bleeding complications related to endovascular procedures. These medical procedures treat problems, such as aneurysms, that affect blood vessels. Around 20 percent of patients suffer a bleeding complication during endovascular procedures.

Reinstein explains that the way health tech funding trended over the past 18 months greatly affected Saranas. The device fell outside the parameters of what investors were looking for during this pandemic time. However, Reinstein explains, the Early Bird worked and had FDA approval — that made all the difference.

"We are very confident that the product does work and it can have a significant impact for hospitals and patients," Reinstein says. "Eventually, the term sheets came in."

Saranas announced in July that it closed a $12.8 million series B investment led by Wisconsin-based Baird Capital, the venture capital and global private equity arm of Baird, a global company with a location in Houston. Austin-based S3 Ventures also supported the round.

The funds will propel Saranas into its next phase, which includes growing its team, larger trials, and a next-generation product.

Reinstein has had decades in health care innovation all over the world, with a large chunk of his career at Boston Scientific. He's seen Houston's innovation ecosystem evolve.

"I do think that there's a great potential for Houston to really develop the industry," Reinstein says. "There's just two areas that need to get fortified. One is the funding and getting the funds directed to Houston companies — with the idea that the company stays in Houston. ... The other side of the coin is really finding the talent to come in and run the companies, take on leadership positions."

Reinstein shares more details on what's next for Saranas, as well as his advice for med tech entrepreneurs and observations on Houston's innovation ecosystem on the show. Listen to the full interview below — or wherever you stream your podcasts — and subscribe for weekly episodes.


This week's roundup of Houston innovators includes Will Womble of Umbrage, Katie Mehnert of ALLY Energy, and James Reinstein of Saranas. Courtesy photos

3 Houston innovators to know this week

who's who

Editor's note: In this week's roundup of Houston innovators to know, I'm introducing you to three local innovators across industries — from energy to health care — recently making headlines in Houston innovation.

Will Womble, CEO of Umbrage

Startup founder on how Houston has evolved as a software hub — and why there's no better place to be

Will Womble joins this week's episode of the Houston Innovators Podcast. Photo courtesy

Will Womble describes his company, Umbrage, as fiercely loyal to Houston. The business, which publicly launched earlier this year, supports companies large and small with their software design, development, and more. Womble says he saw a void in Houston for this type of company, and he's attempting to fill it.

"What makes us different is speed to market — we're all onshore. We're all Houston-based, with the exception of five of our 40 employees," Womble says. "Houston was our focus and mission."

Womble has seen Houston evolve as an innovation ecosystem over the years, and now the game has changed. Click here to read more.

Katie Mehnert, founder and CEO of ALLY Energy

Katie Mehnert's company, ALLY Energy, has made an acquisition. Photo via Katie Mehnert

ALLY Energy announced it has acquired Clean Energy Social, a jobs and networking community for the clean energy industry. The deal expands ALLY's platform into the solar, wind, power, oil and gas, power and utilities, biofuels, hydrogen, geothermal, carbon capture, and other sectors that make up the energy transition.

"It's time to tackle the enormous challenge of the energy transition by connecting companies and candidates to resources so we can reduce the time and capital it takes to recruit and reskill," says Katie Mehnert, founder and CEO of ALLY Energy, in a news release. "We can speed up decarbonization by centralizing resources into one digital experience. This acquisition is a much-needed human capital investment to advance net-zero goals." Click here to read more.

James Reinstein, president and CEO of Saranas

Saranas closed its series B round this week. Photo via Saranas.com

Saranas Inc. announced that it closed a $12.8 million series B investment led by Wisconsin-based Baird Capital, the venture capital and global private equity arm of Baird, a global company with a location in Houston. Austin-based S3 Ventures also supported the round. The company will use the funds to continue its clinical trials, per a news release.

"We are pleased to announce this round of funding led by Baird Capital," says Saranas President and CEO James Reinstein in the release. "It underscores the importance of real-time monitoring of bleeding complications and our opportunity to accelerate the commercialization of Early Bird. We look forward to expanding our clinical evidence through prospective clinical trials and launching next generation products, including Bird on a Wire, to address a much broader range of endovascular procedures." Click here to read more.

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$5B Austin medical center, anchored by MD Anderson, to break ground this fall

moving forward

Construction on the $1 billion first phase of the AI-native University of Texas Dell Medical Center in Austin—which will feature a hospital operated by Houston’s UT MD Anderson Cancer Center—is set to start this fall.

The UT System Board of Regents approved funding for first-phase construction on Aug. 12.

The medical center—now expected to cost $5 billion, up from the initial $2.9 billion estimate—will span about 2.5 million square feet. It will include 300 to 500 patient beds, outpatient facilities, an emergency department and specialized care for cancer patients.

MD Anderson will bring its world-renowned oncology programs to the center’s integrated health care model, Dr. Claudia Lucchinetti, senior vice president of medical affairs at UT Austin and dean of the university’s Dell Medical School, tells Health Leaders.

Earlier this year, Austin tech billionaire Michael Dell and his wife, Susan, pledged $750 million for development of the medical center. The medical center, scheduled for completion in December 2030, will be a cornerstone of the new 300-acre UT Dell Campus for Advanced Research, a medical education and research hub.

“Through this new campus and medical center, Texas will lead America in health care innovation,” Gov. Greg Abbott said when the research campus was announced in April. “The next generation of medical breakthroughs will take place in Central Texas.”

The medical center will fold AI tools and other technology into the infrastructure, rather than having them added after it’s built. Among other capabilities, the technology will monitor real-time medical data, automate data entry, and help health care professionals quickly predict and identify risks to patients, according to Health Leaders.

“We are not just building a new medical center,” Lucchinetti says. “We are building a fundamentally new model of health. It’s not just a new facility. It’s not just a new collaboration. It is a convergence of capabilities that rarely come together at the same time.”

Houston hospital ranks among 20 best in U.S. & more top innovation news

Trending News

Editor's note: August is off to a strong start with these five big innovation headlines to know. From the annual U.S. News ranking of best hospitals to a big Series A raise, here are the most-read Houston innovation stories published July 31-August 14, 2026:

1. U.S. News declares Houston hospital No. 1 in Texas for the 15th year

Houston Methodist Hospital and over a dozen more Houston-area hospitals have earned bragging rights in U.S. Houston Methodist was also the only Texas institution named on U.S. News' Best Hospitals Honor Roll, a prestigious list of the 20 best medical centers in the country. Houston Methodist also reigns as Texas' best hospital for the 15th consecutive year. Continue reading.

2. Houston startup lands $10M to power up electrician staffing platform

Houston-based Buildforce, which provides a tech-enabled staff platform geared toward electricians and electrical contractors, has raised a $10 million Series A round led by Houston’s Saepio Capital. Other investors in the round include Blue Heron Capital, Revolution’s Rise of the Rest Seed Fund, S3 Ventures and Chicago Ventures. Buildforce says the funding will help fuel its national expansion and further development of its technology. Continue reading.

3. UTHealth Houston joins NASA initiative to protect border drinking water

Climate change means far more to public health than living with hotter days. Transformations in our weather are contributing to challenges in accessing safe drinking water in some communities. One of the most dire situations is along the US–Mexico border. NASA is seeking to address that issue with its Water Quality Applications program. An 11-researcher project led by a UTHealth Houston School of Public Health faculty member has been selected to participate. Continue reading.

4. KBR unveils name, branding for new government services spinoff

Houston-based KBR Inc.'s new Mission Technology Solutions unit officially has a name. The previously announced government services spinoff, which until now has been nicknamed SpinCo, will now be known as Trinzic. The company said in a news release that the name was inspired by the word intrinsic, "reflecting essential, built-in capabilities and deep expertise operating in some of the world’s most complex and mission-critical environments." Continue reading.

5. Who are Houston's top innovators? Nominate now for 2026 Houston Innovation Awards

Calling all Houston innovators: The 2026 Houston Innovation Awards, presented by InnovationMap, return this fall to celebrate the best and brightest in the Houston innovation ecosystem right now. We're asking you to nominate Houston's top innovators and startups for this year's awards. Nominations are open through August 27 and can be made on behalf of yourself, your organization, and other influential leaders in the local innovation scene. Continue reading.

Rice lands $15M U.S. Army award to launch next-gen wireless research center

defense funding

The U.S. Army Research Office has awarded Rice University $15 million to establish a new center for next-generation sensing and communications.

The five-year research center—dubbed the Center for Large Aperture Secure Sensing, Imaging and Communications (CLASSIC)—will unite researchers from universities and national laboratories to develop advanced antenna technologies for future wireless systems. Edward Knightly, the Sheafor-Lindsay Professor of Electrical and Computer Engineering at Rice, will lead the center that “combines expertise in wireless networking, antennas, radar, artificial intelligence, circuits and physics to address growing demands on wireless systems,” according to Rice.

“The challenges we’re tackling require advances that span physics, hardware, communications and computing," Knightly said in a news release. “By combining those strengths in a single center, we can accelerate the development and demonstration of technologies that would not be possible through individual efforts alone.”

Joining Knightly will be Ashutosh Sabharwal of Rice, Sensen Li of the University of Texas at Austin, Hou-Tong Chen of Los Alamos National Laboratory, Danijela Cabric of UCLA, Josep M. Jornet and Tommaso Melodia of Northeastern University, Daniel M. Mittleman of Brown University, and Willie Padilla of Duke University.

Industry partners include Booz Allen Hamilton, Intel, Keysight, Lockheed Martin, MITRE, Northrop Grumman, Qualcomm and Raytheon.

CLASSIC researchers will investigate how large-scale antenna arrays (ELSAAs) can expand the capabilities of wireless systems where technology is limited.

ELSAAs use thousands of coordinated antenna elements to direct radio waves. Researchers aim to develop ways to use the technology to help maintain steady communication when signals are blocked or disrupted and to detect and generate detailed images of concealed objects.

Along with ELSAAs, the center will work to develop sensing techniques for threat detection, study wireless jamming and build resilient high-speed wireless networks. Researchers will ultimately validate the technology in labs and via drone-based field trials.

CLASSIC will also work on developing an AI-driven modeling framework that will simulate complex electromagnetic environments in real time.

“This award demonstrates Rice’s leadership in tackling complex national research challenges through collaboration across disciplines and institutions,” David Sholl, executive vice president for research at Rice, added in the release.

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