Houston medical device company gains FDA approval

EarlyBird got the worm

Houston-based Saranas has received de novo distinction from the FDA for its bleed monitoring technology. Courtesy of Saranas

When it comes to early bleeding detection, Houston-based Saranas, which closed $2.8 million in funding last year, is ahead of the game with its Early Bird Bleed Monitoring System. The Food and Drug Administration has recognized the medical device company and granted it De Novo distinction.

"Gaining FDA approval for the Early Bird is a significant milestone for Saranas as it demonstrates our continued commitment to address an unmet need for real-time detection and monitoring of endovascular bleed complications," says Saranas president and CEO, Zaffer Syed in a release. "As the first and only device on the market for early bleed detection, we have the potential to significantly reduce bleeding complications and related healthcare costs, while improving clinical outcomes in patients undergoing endovascular procedures."

The Early Bird technology is designed to detect bleeding from vessel injury caused by a surgery, for instance. One in five patients experienced a bleed complication in over 17,000 large-bore transcatheter procedures, according to the release which cites the National Inpatient Sample Database.

"Bleeding remains an Achilles' heel of advancing minimally-invasive, catheter-based procedures," says Dr. Dimitrios Karmpaliotis, director of Chronic Total Occlusions, Complex and High Risk Angioplasty at Columbia University Medical Center, in the release. "The Early Bird will play a key role in making these procedures safer in the future by providing physicians bleed monitoring in real-time."

In May, Saranas received $2.8 million in funding $2.8 million in funding from investors to enable testing of Early Bird. In all, the startup has collected $12 million from investors. A month after the funding announcement, Saranas was one of 50 startups chosen for the MedTech Innovator program, which nurtures medical technology companies.

Currently in the piloting stage, Saranas plans to commercially launch the Early Bird Bleed Monitoring System in select markets across the United States. Currently, the company hasn't disclosed a timeline for that roll out.

The De Novo distinction's purposes is to review new technologies and mitigate risk as they prepare to enter the market. In December, the FDA proposed new procedures and criteria for the De Novo classification process.

"The De Novo pathway for novel medical devices allows the FDA to conduct a rigorous review of new technologies so that patients have timely access to safe and effective medical devices to improve their health," says FDA Commissioner Scott Gottlieb, in a release. "At the same time, the FDA is modernizing its 510(k) pathway, which is used for clearance of low- to moderate-risk devices that are substantially equivalent to a device already on the market. The De Novo pathway provides a vehicle for establishing new predicates that can reflect modern standards for performance and safety and can serve as the basis for future clearances. Our goal is to make the De Novo pathway significantly more efficient and transparent by clarifying the requirements for submission and our processes for review."

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Baylor, Rice win $500,000 to launch humanities-driven health AI center

ethical AI

Baylor College of Medicine and Rice University have been awarded a $500,000 grant from the National Endowment for the Humanities (NEH) to create the Center for Humanities-based Health AI Innovation (CHHAIN).

The new center and three-year initiative aims to create ethically responsible and trustworthy AI for health care that uses history and patient narratives to shape the technology, according to a release. It represents a collaboration between the Center for Medical Ethics and Health Policy at Baylor and the Medical Humanities Research Institute at Rice. Ultimately, the researchers aim to establish a national model for integrating the humanities into the design and implementation of health AI.

Vasiliki Rahimzadeh, assistant professor at Baylor in the Center for Medical Ethics and Health Policy, and Kirsten Ostherr, director of the Medical Humanities Research Institute at Rice, will serve as co-directors of the new center, which will be housed within the Center for Medical Ethics.

The team will also engage in strategic collaborations with Kirstin Matthews, Rice’s Baker Institute for Public Policy and its fellow in science and technology policy, as well as Dr. Quianta Moore, executive director of the Meadows Mental Health Policy Institute. An interdisciplinary team of medical humanities and bioethics scholars from Baylor, Rice, and partners in the Houston area will complete the group.

“CHHAIN represents a bold new model for integrating the humanities into health innovation,” Ostherr said in a news release. “It will create a collaborative space where humanities scholars, patients, developers and clinicians can come together to explore the human dimensions of health AI—trust, narrative and lived experience. These are essential perspectives that are too often missing from technology development, and CHHAIN is designed to change that."

CHHAIN’s work will revolve around three key points:

  • Defining trustworthy AI through patient voices
  • Translating humanities insights into clinical AI settings
  • Public engagement and policy translation

“For AI to truly improve health outcomes, it must be designed with patient trust and wellbeing at its core,” Rahimzadeh said in the news release. “CHHAIN will provide a dedicated space to explore critical bioethics questions, such as how we ensure AI respects patient autonomy, addresses the needs of underserved communities and integrates meaningfully into clinical care. Our goal is to translate these insights into real-world health settings where AI is already shaping patient experiences."

CHHAIN's research mission was also developed thanks to pilot funding from the Margaret M. and Albert B. Alkek Department of Medicine at Baylor and a grant from Rice's Provost's TMC Collaborator Fund.

Texas A&M, the University of North Texas and the University of Texas at El Paso were also home to some of the 97 projects that received a portion of the $34.79 million in fundning from the NEH. See the full list here.

Houston booms as No. 2 U.S. market for retail construction in 2025

Construction Zone

Get ready for a gigantic cartload of new shopping opportunities in Houston. A new report indicates the equivalent of 21 Walmart supercenters is under construction in the region.

The report, published by commercial real estate services provider Lee & Associates, says Houston has nearly 3.9 million square feet of retail space under construction, making it the second most active market for new retail space in the U.S.

To put that in perspective, given the average Walmart supercenter measures 182,000 square feet, the 3.9 million-square-foot total would work out to 21 new supercenters being built in the region.

Dallas-Fort Worth is by far the most active U.S. market for new retail space; DFW leads more than 60 U.S. retail markets with nearly 7.15 million square feet of space under construction. The amount of retail space going up in DFW represents 15 percent of all retail space under construction in the more than 60 U.S. markets tracked by Lee & Associates.

Houston and Austin aren’t too far behind Dallas-Fort Worth, though.

Third-ranked Austin area has more than 3.4 million square feet of retail space being built.

What’s behind the surge in retail construction across Texas? Population growth.

Data recently released by the U.S. Census Bureau shows Houston was the second-fastest-growing metro from 2023 to 2024. DFW was the country’s third-fastest-growing metro from 2023 to 2024, based on the number of new residents, and Austin landed at No. 13.

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This article originally appeared on CultureMap.com.

Intuitive Machines to acquire NASA-certified deep space navigation company

space deal

Houston-based space technology, infrastructure and services company Intuitive Machines has agreed to buy Tempe, Arizona-based aerospace company KinetX for an undisclosed amount.

The deal is expected to close by the end of this year, according to a release from the company.

KinetX specializes in deep space navigation, systems engineering, ground software and constellation mission design. It’s the only company certified by NASA for deep space navigation. KinetX’s navigation software has supported both of Intuitive Machines’ lunar missions.

Intuitive Machines says the acquisition marks its entry into the precision navigation and flight dynamics segment of deep space operations.

“We know our objective, becoming an indispensable infrastructure services layer for space exploration, and achieving it requires intelligent systems and exceptional talent,” Intuitive Machines CEO Steve Altemus said in the release. “Bringing KinetX in-house gives us both: flight-proven deep space navigation expertise and the proprietary software behind some of the most ambitious missions in the solar system.”

KinetX has supported deep space missions for more than 30 years, CEO Christopher Bryan said.

“Joining Intuitive Machines gives our team a broader operational canvas and shared commitment to precision, autonomy, and engineering excellence,” Bryan said in the release. “We’re excited to help shape the next generation of space infrastructure with a partner that understands the demands of real flight, and values the people and tools required to meet them.”

Intuitive Machines has been making headlines in recent weeks. The company announced July 30 that it had secured a $9.8 million Phase Two government contract for its orbital transfer vehicle. Also last month, the City of Houston agreed to add three acres of commercial space for Intuitive Machines at the Houston Spaceport at Ellington Airport. Read more here.

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