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

CORONAVIRUS RESPONSE

The at-home COVID-19 tests are now available. EverlyWell/Facebook

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.

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This article originally ran on CultureMap.

EverlyWell's online results will be available within 48 hours. EverlyWell/Facebook

Texas company first to launch at-home test for COVID-19

COVID-19 WATCH

As reports keep indicating a shortage of supply for COVID-19 tests around the country, a Texas startup has rolled out a new at-home test for consumers beginning today, March 23.

Everywell, which already offers an array of at-home lab tests, says 30,000 COVID-19 tests will be available in the initial batch. Free telehealth consultations will be provided for people who test positive for COVID-19, or the coronavirus.

As TIME first reported, this is the first U.S. company to offer at-home COVID-19 test kits directly to consumers.

"The extreme shortage of tests for COVID-19 puts millions of Americans at risk," Julia Cheek, founder and CEO of Everlywell, said in a March 18 release. "Everlywell is committed to helping stop the spread of COVID-19 in the U.S. by making this test widely available. As the national leader in at-home lab testing, we want to use our resources and expertise to help as many people as we can. We are committed to this fight, and we're here to help."

Working with a number of diagnostic labs, Everlywell plans to create testing and diagnosis capacity for 250,000 people per week.

Everlywell recently launched a $1 million program aimed at encouraging labs to fast-track development of an at-home COVID-19 diagnostic test. Many labs stepped up to the task, enabling Everlywell to create a COVID-19 testing and diagnosis infrastructure in a matter of days.

"Our team has been working around the clock with top scientists and laboratories in the nation to develop a test that we will make available at the lowest price possible while covering our costs, at no profit to the company," Cheek says. "We have also reached out to government and public health officials to explore possibilities to provide it for free."

Each test costs $135, and is covered by participating providers of health savings accounts and flexible spending accounts.

The test can be requested online by consumers experiencing COVID-19 symptoms. Samples can be collected at home, preventing further exposure for consumers and the public. All of Everlywell's lab partners conducting COVID-19 tests comply with the U.S. Food and Drug Administration's emergency rules for COVID-19 testing.

"Given the high demand for testing, the company will work rapidly to make more tests available as the global supply shortage for COVID-19 diagnostic kits is addressed," the company says.

Like Everlywell's other tests, the COVID-19 test will be shipped to customers with everything needed to collect a test sample at home and safely send that sample to a certified lab. Samples will be shipped to labs overnight, secure online results will be available within 48 hours of the lab receiving a sample, and a free telehealth consultation with an independent board-certified physician will provided to anyone who tests positive.

Anyone seeking a test will be asked to fill out an online screening questionnaire.

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This article originally ran on CultureMap.

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What to expect from the inaugural TiECon Texas event this week

where to be

Innovators and entrepreneurs will gather in Houston this week to show off their latest advancements in automation during the first-ever TiECon Texas conference at the Ion District.

“Automation is not simply changing how we work. It is redefining how value is created across every industry,” Somesh Singh, president of TiE Houston, said in a release. “Texas has the talent, the infrastructure, and the entrepreneurial spirit to lead this transformation. TiEcon Texas 2026 is where the people building that future will come together to shape it."

The Indus Entrepreneurs (TiE) started in Silicon Valley in 1994 as a two-day seminar, but has grown into a worldwide network of events celebrating technological advancement. TiECon in Houston is a merger of the TiE networks across Texas for one large-scale event taking place at the Ion on Wednesday, October 28, and Thursday, October 29. Tickets are available here.

The event includes a partnership with Hatch Pitch, a founder-first startup showcase that has raised over $20 billion in funding for new companies in the tech industry. Participants will come from industries like space exploration, healthcare, energy, and the AI sector to present their ideas in front of an investor network for possible development.

“Over 80 percent of the teams we have coached have gone on to receive funding,” Greg Wright, founder of Hatch Pitch, added in a release.

In addition, there will be forums and talks on a variety of automation subjects, everything from robotic surgery to automation in government. Educators from Baylor College of Medicine, UTHealth Houston, and the University of Houston plan to discuss the raising of children in a world with extensive artificial intelligence integrated into so many areas. Steven Kean, President and CEO of the Greater Houston Partnership, will give the keynote speech on the Bayou City’s place in these emerging technological spheres.

Singh highlighted how the large-scale disruptions in the technological status quo by the rise of AI could be a sign of potential growth and innovation. The entrepreneurs presenting at TiECon may be the ones to harness the sometimes unsteady AI industry for good causes.

“History shows that periods of technological disruption create extraordinary opportunities for those prepared to act,” he said. “TiEcon Texas is designed to help founders, investors, and enterprises understand where the automation economy is headed and how to participate in building it."

Here are the 10 startups pitching during the TiE Hatch Pitch competition:

Houston startup makes Time's list of the best inventions of 2026

Innovation Station

One of the year's most buzzworthy innovations comes from a Houston-based leader in the energy transition. Utility Global's H2Gen recently made Time magazine’s list of the 300 best inventions of 2026.

The H2Gen is an innovative system that produces low-cost clean hydrogen from water and industrial off-gases. The company says the process doesn’t require electricity, a notable claim since hydrogen production typically consumes a lot of power.

"Using a tubular electrochemical cell containing a proprietary electrolyte and water, the company can turn industrial off-gases into hydrogen at scale—no extra electricity required," writes Time. "Bonus: the process also pulls out carbon dioxide as a separate stream, where it can be captured and kept out of the atmosphere.

CEO Parker Meeks tells Time, it's “a practical pathway to decarbonize existing industrial assets."

The startup is on a roll. It has raised $100 million so far in an ongoing Series D round to offer its decarbonization technology at industrial scale around the world.

H2Gen is joined by 10 other inventions with Texas connections onTime's list, as well as one "special mention."

In North Texas, they are:

Samsung
Plano-based Samsung Electronics America pulled off a hat trick this year, with three products making Time’s list. First up is the Galaxy S26 Ultra smartphone. It packs a more powerful camera, Galaxy AI features, and pro-level content creation tools. But Time singled out its new built-in privacy display as the phone’s “biggest selling point.”

Samsung’s Bespoke AI Family Hub refrigerator also got smarter. When AI first came to the Family Hub in 2024, it could recognize some fresh foods, but you still had to log packaged items by hand, Time noted. Now, with Google Gemini built in, the fridge can identify more than 2,000 packaged foods, read handwritten labels, and warn you when food is about to expire. It then uses what’s inside to build grocery lists and suggest recipes.

And for gamers, there’s the Odyssey G8 monitor. Its 6K resolution leapfrogs the 4K standard, delivering what Samsung calls “exceptional visual clarity and detail” on a screen big enough for gaming and multitasking.

OxeFit
Plano-based OxeFit’s XS1 Peak is about the size of a treadmill but works like an entire gym. It can be set up for strength training, simulated skiing or kayaking, Pilates, or rowing. What makes it stand out is a built-in virtual spotter. According to Time, the machine “uses AI, computer vision and sensors to correct the user’s form, change resistance in the middle of a rep and reduce the weight when the user is struggling, much like a human spotter.”

EssilorLuxottica
EssilorLuxottica, the French eyewear giant whose U.S. headquarters is in Farmers Branch, makes Essilor Stellest lenses. The lenses correct nearsightedness while also slowing the eye growth that makes it worse over time. Stellest is the first and only eyeglass lens authorized by the U.S. Food and Drug Administration to control myopia, Time said. The lenses look like regular glasses but contain 1,021 tiny lenslets. In a U.S. trial of kids ages 6-12, myopia progression slowed by an average of 71 percent over two years compared with standard lenses.

Helpany
Helpany, a startup based in Phoenix that manufactures its devices in DFW, makes Paul, a ceiling-mounted gadget that uses radar and AI to spot subtle changes in how residents move and flag those at higher risk of falling. Helpany says the technology can cut falls by as much as 72 percent.

Aurora Innovation
Aurora, based in Pittsburgh with a corporate and operations hub in Coppell, rolled out its second-generation Driver 2 system in July. By September, Driver 2 trucks had logged more than 500,000 driverless miles without a single at-fault crash, Time reported, and the company expects 200 of them on the road by the end of 2026.

Colossal Biosciences
Dallas-based Colossal Biosciences built an artificial egg by placing an ultra-thin, transparent silicone membrane inside a rigid 3D-printed cup, letting scientists watch the embryo develop. Twenty-six chickens have already been hatched.

In Austin, they are:
Cedar Park-based Hyliion landed on Time’s list with its Karno Power Module, a modular generator designed to produce power wherever it’s needed. The Karno represents a big pivot for the company. Hyliion got its start building electrified powertrains for 18-wheelers before shifting into power generation after acquiring the Karno generator technology from GE Aerospace. Founded in Pittsburgh in 2015, the company relocated to Cedar Park in 2018.

The other Austin-associated honoree is Moment Energy. As more electric vehicles hit the road, a growing number of their batteries are nearing retirement, while demand for power keeps climbing. Moment Energy found a way to tackle both problems at once. The company’s Megafactory 1, which opened in Vancouver, Canada, in June, turns old EV batteries into modular energy storage systems for hospitals, factories, data centers, and other big power users. “Our goal is to make sure these batteries don’t end up in landfills,” founder Edward Chiang told Time.

In the “Special Mentions” category, Austin-based Renzoe Box gained notice for its refillable custom makeup palette for on-the-go people. Licensed architect René Graham designed the box. She graduated from Houston's Rice University, and was born and raised in Dallas.

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A version of this article first appeared on CultureMap.com.

4 Houston health tech startups advancing medical innovation

meet the finalists

Houston has been driving medical innovation for decades. And thanks to leading hospitals, cutting-edge research and breakthrough technologies, the region’s healthcare ecosystem continues to improve how patients are diagnosed, treated and cared for.

The Health Tech Business category in our 2025 Houston Innovation Awards will honor an innovative startup within the health and medical technology sectors.

Four forward-thinking businesses have been named finalists for the 2026 award. This year's finalists, selected by our esteemed panel of judges, range from a startup developing miniaturized medical technologies for space to a company using AI to help develop cancer treatment plans.

Read more about these businesses, their innovative founders, and how they're shaping the future of health care below.. The 2026 winners will be announced on InnovationMap.com in mid-November.

Bairitone Health

Bairitone Health is bringing anatomy imaging for sleep apnea to the home environment. The company's platform maps users' anatomy during natural sleep using a facial patch to determine the root cause of airway obstruction. It then offers effective therapies for each patient.

The company was founded in 2022 in the Texas Medical Center's Biodesign program by CEO Meagan Pitcher, CTO Onur Kilic and chief medical officer Britt Cross. It was a member of Activate Houston's inaugural cohort and has participated in numerous accelerators and incubators. The company raised an oversubscribed seed round for $2.4 million earlier this year and received Breakthrough Device Designation from the Food and Drug Administration in April.

InformAI Inc.

InformAI Inc. develops fit-to-purpose AI solutions for the clinical setting. Its RadOncAI product recently received FDA 510(k) clearance. The product uses AI to create a first-pass radiation therapy dose plan for complex head and neck cancers in an effort to eliminate bottlenecks in radiation planning and ultimately cancer treatment. The company has also developed AI products for sinus disease detection and 3D organ reconstruction.

CEO Jim Havelka founded the company in 2017. It is participating in the Mayo Clinic Accelerate Platform. It has raised about $4 million in seed funding and has received numerous non-dilutive grants from the National Science Foundation, the National Institutes of Health and the Cancer Prevention and Research Institute of Texas. The company shared in its application that it plans to launch a Series A fundraising round and submit an FDA 510K application for its organ reconstruction product, Voluquant, by the end of 2026.

Prana Surgical

Prana Surgical is developing a minimally invasive surgical platform for small, hard-to-reach lung nodules that may be cancerous. The company's Prana System cleared U.S. Food and Drug Administration (FDA) approval earlier this year.

Prana Surgical was originally founded as Prana Thoracic in 2022. It has participated in numerous accelerators, including the Texas Medical Center Innovation Accelerator in 2023 and the IGNITE Health accelerator in 2022. It raised $6 million in Series A funding rounds in 2023 and 2024 , with a Series B currently ongoing. The company said in its application that it is currently moving into the next stage of clinical validation and revenue generation in the U.S., in addition to preparing its manufacturing and commercial infrastructure for broader use.

Skybound MedTech

Skybound MedTech develops technologies that aim to address the health risks of long-duration spaceflight. Its compact, miniaturized medical technologies can deliver complex therapies without a physician.

CEO Matthew Kuhn, who previously founded Taurus Vascular, founded Skybound last year. The company emerged from stealth in January after raising a $1.25 million Series A round. It plans to advance its lead dual-use platform into critical preclinical validation in November, the company shared in its application. It is currently raising a $25 million Series A round and is pursuing federal research partnerships with DARPA and ARPA-H.

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