Houston medtech startup clears FDA approval for new surgical tool

precision surgery

Prana Surgical has developed a minimally invasive, image-guided, single-use tissue extraction tool. Photo via LinkedIn

Houston-based Prana Surgical will soon bring a new electrosurgical tool to operating rooms around the country. The Prana System officially cleared U.S. Food and Drug Administration (FDA) approval earlier this month.

"Receiving FDA clearance for the Prana System represents a defining milestone for our company," Joanna Nathan, CEO and co-founder of Prana Surgical, said in a news release. "Surgeons today are increasingly focused on achieving precise outcomes while minimizing disruption to healthy tissue. The Prana System was designed to support that shift by integrating targeting and excision into a single, streamlined tool."

Prana Surgical began as Prana Thoracic in 2022. Back then, the company primarily focused on developing screening tools for lung cancer diagnosis. It raised $6 million in series A funding rounds in 2023 and 2024 before transitioning to broader surgical needs in 2025.

The Prana System is a minimally invasive, image-guided, single-use tissue extraction tool designed to retrieve samples without damaging healthy tissue. The tool is still designed with the respiratory system in mind, helping Prana in the fight against lung cancer and other thoracic diseases.

Reducing the impact of tissue extraction via electrosurgery and enhanced image scanning can significantly reduce complications. The Prana System combines localization and tissue-cutting capabilities in one, which keeps surgeons from having to swap out components during a procedure, making for a smoother process. It can core, cut and feel blood vessels on the way toward the intended target, giving surgeons greater control over tissue preservation.

"Electrosurgery is foundational to modern surgery, but there is still opportunity to improve how energy-based tools are applied in minimally invasive settings," Nathan added. "Our goal is to introduce a new class of image-guided surgical tools that enable more precise intervention across a range of procedures."

The company projects the market size for lung nodules to be $7.5 billion in the United States, estimating that 2.5 million nodules will be able to benefit from the new tool. While starting out focused on biopsies, the company plans to evolve the system into other procedures, such as ablation, in the future. It is also planning for a controlled U.S. clinical rollout as it moves toward commercialization

From Your Site Articles
The at-home COVID-19 tests are now available. EverlyWell/Facebook

Texas startup’s at-home COVID-19 test finally approved by feds

CORONAVIRUS RESPONSE

After its earlier effort was tripped up, Austin-based startup Everlywell on May 16 finally gained approval from the U.S. Food and Drug Administration to launch its at-home coronavirus test.

In a May 18 release, Everlywell says the self-administered test will be available later this month. The company, which specializes in at-home tests for an array of conditions, is the first to receive approval from the FDA for an at-home coronavirus test that's not associated with a lab or a manufacturer of diagnostic products.

The FDA's emergency authorization allows Everlywell to work with a number of certified labs that process authorized tests, rather than just a single lab.

"The authorization of a COVID-19 at-home collection kit that can be used with multiple tests at multiple labs not only provides increased patient access to tests, but also protects others from potential exposure," Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, says in a release.

Everlywell's at­-home test determines the presence or absence of the novel coronavirus, which causes COVID­-19 illness. Everlywell's test kit uses a short nasal swab and includes:

  • A digital screening questionnaire reviewed by a healthcare provider.
  • Instructions on how to ship the test sample to a lab.
  • Digital results within 48 hours of the sample being received by the lab.
  • Results reviewed by an independent physician.

Anyone who tests positive test will receive a telehealth consultation. All positive test results are reported to federal and local public health agencies when mandated.

On March 23, Everlywell was supposed to start shipping 30,000 coronavirus test kits to U.S. consumers. But before a single test was sent, the FDA blocked distribution of at-home, self-administered tests from Everlywell and other companies. After that, Everlywell pivoted to supplying coronavirus tests to health care providers and organizations.

As with the company's previously approved coronavirus test, Everlywell says its test for individuals is sold at no profit. The $109 price covers costs such as overnight shipping to a lab, lab-processing fees, and kit components. Some health insurers cover coronavirus tests.

Everlywell says it's working with members of Congress to enable companies that are neither healthcare providers nor labs to be directly reimbursed by health insurers. The startup also is exploring how its coronavirus test could be made available for free.

"Widespread access to convenient testing will play a crucial role in the country's ability to address the pandemic and prevent overburdening our healthcare facilities. As the national leader in connecting people with high­-quality laboratory testing, we are committed to fighting the spread of this virus in America," Julia Cheek, founder and CEO of Everlywell, says in the Everlywell release.

The company continues to supply its coronavirus tests to qualified healthcare organizations and government agencies.

------

This article originally ran on CultureMap.

Ad Placement 300x100
Ad Placement 300x600

CultureMap Emails are Awesome

Property Showcase

European spacecraft developer expands to Houston with U.S. business, new lab

houston hq

European aerospace manufacturer The Exploration Company has established its first U.S. entity and named Space City as its headquarters.

The company announced earlier this month that it has launched TEC Federal to support U.S. government customers and agencies, and to scale The Exploration Company's engineering operations in the country.

Mark Kirasich serves as president of TEC Federal. Kirasich most recently served as the senior director of human spaceflight at Blue Origin after a nearly 40-year career at NASA.

The Exploration Company is developing the reusable Nyx space vehicle. Nyx is designed to take off from any heavy launcher in the world. It will then dock at space stations, retrieve up to 3,000 kilograms of cargo, splash down and return the cargo to Earth. The company aims to make Nyx fully reusable for up to 10 missions, making it a more affordable and sustainable option for aerospace missions.

The Exploration Company completed a successful drop test of the spacecraft in May in the Mojave Desert. The company says Nyx is slated to perform its first flight demonstration in 2028.

In addition to launching the Houston business, The Exploration Company also opened its new Rapid Innovation Lab near Houston's NASA Johnson Space Center on Space Park Drive.

The Exploration Company opened its Rapid Innovation Lab earlier this month. Photo via LinkedIn

The Rapid Innovation Lab features a full-scale mockup of the future Nyx crew capsule as well as ongoing development and testing of the Nyx cargo capsule, according to the company.

The Exploration Company says the new lab will allow its engineers, designers, and operators to prototype and test crew interfaces. It will also support partnerships with NASA personnel and astronauts.

“Houston gives us direct access to the people and expertise that have built and operated human spaceflight systems for decades. We’re excited to invest and expand around that— engineers, operators, and astronauts working together and moving quickly towards building a crew capsule.” Hélène Huby, founder and CEO of The Exploration Company, said in a blog post.

According to The Houston Chronicle, The Exploration Company has about 30 employees in the Houston area.

The company was founded in 2021 by Huby, a French rocket scientist, and has raised more than $350 million in venture capital. It operates out of Germany, France, Luxembourg, Spain and Italy, with offices in the U.S. and the United Arab Emirates. It is also developing a reusable, high-thrust rocket engine known as Storm.

Exciting XSpace expansion plans + more top Houston innovation headlines

Trending Topics

Editor's note: The top Houston innovation headlines for the first half of July include XSpace's expansion and KBR's C-suite hires. Here is a recap of the five most-read InnovationMap stories published July 1-15, 2026:

1. XSpace plans $250M industrial condo expansion with RAFA Racing Club

nullXSpace plans $250M industrial condo expansion with RAFA Racing Club

Houston-based XSpace Group has teamed up with two other Houston companies, RAFA Racing Club and Maximo Capital, to develop five industrial condo projects that pair flex space and high-end car storage space with a members-only clubhouse for motorsports enthusiasts. The five projects will be built in the Dallas-Fort Worth; Miami-Boca Raton; Charlotte-Mooresville, North Carolina; Phoenix-Scottsdale; and Los Angeles markets. Continue reading.

2. KBR names C-suite duo to lead $5.3B government services spinoff

In advance of the spinoff of its Mission Technology Solutions unit, Houston-based KBR has made two C-suite hires for the new business. Michael LaRouche is coming aboard as president and CEO of the spinoff, currently called SpinCo, on Sept. 26. Nicholas Veasey joined as executive vice president and chief financial officer on July 1. Continue reading.

3. Experts: Houston's VC ecosystem has set the foundation — now we need scale

Fervo Energy went public earlier this summer. The Houston geothermal company priced its IPO at $27 per share, raised $1.89 billion, and opened the next morning at a market capitalization north of $10 billion. By most measures, it is the largest venture-backed cleantech IPO in history and an unambiguous win for Houston. It’s also a useful moment to look at where Houston's venture ecosystem stands and where it can go. The highlight: Houston's venture ecosystem has real foundations and, with increased company formation activity, can grow into the scale our city's ambitions deserve. Continue reading.

4. $12M pharmaceutical manufacturing facility to be built in Sugar Land

A nearly $12 million drug manufacturing facility is coming to Sugar Land. City leaders in Sugar Land recently approved a $1.3 million performance-based incentive for DeliverIt Group, a Sugar Land-based provider of specialty pharmacy, infusion therapy and clinical care services, for the development of the 60,000-square-foot facility. Continue reading.

5. Walmart expands drone delivery service to 8 new Houston-area stores

More Walmart delivery drones are now buzzing around Houston-area skies. In January, Walmart launched its drone delivery service in partnership with Wing at five locations in the Houston area. The retail giant just added eight more stores to its Houston-area drone delivery network. Wing says the expansion makes drone delivery available to more than 1 million residents of the Houston area. Continue reading.

UH lands $4M NIH grant to study early signs of autoimmune disease

NIH funding

The University of Houston recently received a $4 million National Institutes of Health grant to support a 10-year longitudinal study to identify the earliest biological markers of autoimmune disease.

Led by Chandra Mohan, the Hugh Roy and Lillie Cranz Cullen Endowed Professor of Biomedical Engineering, the study aims to examine what causes Systemic Autoimmune Rheumatic Diseases (SARDs) and to identify targets for future treatments. The study will be carried out in collaboration with Dr. Karen Costenbader at Harvard Medical School, Boston.

SARDs include conditions like rheumatoid arthritis, systemic lupus erythematosus, Sjögren’s syndrome and systemic sclerosis—all are considered chronic diseases currently without a cure. Autoimmune diseases affect over 30 million people globally, according to UH.

SARDs occur when the body’s immune system attacks healthy, non-threatening tissues and organs. According to UH, in these diseases, the body often attacks nuclear antigens, creating anti-nuclear autoantibodies, which can be early detection signs for SARDs in more than 50 percent of patients, Mohan says.

Researchers will study blood samples and environmental exposure over the 10 years to better understand anti-nuclear autoantibodies.

“Collectively, these studies will help identify the genetic, environmental and cellular factors that are operative at the two steps of SARD development, namely the emergence of anti-nuclear autoantibodies and disease onset,” Mohan said in a news release. “ More importantly, these studies will highlight functional molecular pathways and mechanisms that may be operative at each step."

Mohan predicts that looking at SARDs’ shared characteristics, rather than each disease individually, could help identify more treatment methods.

“Individual SARDs have been examined in silos without an attempt to discern shared underlying features at the molecular level,” he added in the release. “Current understanding of the initial (and likely shared) origins of SARDs is only rudimentary but urgently needed to develop means for prevention and treatment.”

Earlier this year, UH also received an $11 million NIH grant to conduct a first-of-its-kind study of early language development in children ages 18 to 24 months. Read more here.

View All Listings