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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CultureMap Emails are Awesome

Houston startups raise funding, secure partnerships across space, health, and sports tech

short stories

It's been a new month and a few Houston startup wrapped up November with news you may have missed.

In this roundup of short stories within Houston startups and tech, three Houston startups across health care, space, and sports tech have some news they announced recently.

Houston digital health company launches new collaboration

Koda Health has a new partner. Image via kodahealthcare.com

Houston-based Koda Health announced a new partnership with data analytics company, CareJourney.

"This collaboration will aim to develop benchmarking data for advance care planning and end-of-life metrics," the company wrote on LinkedIn. "Koda will provide clinical and practice-based expertise to guide the construction of toolkits, dashboards, and benchmarks that improve ACP programs and end-of-life outcomes."

Koda Health announced the partnership in November..

“Beyond the checkbox of a billing code or completed advance directive, it’s important to build and measure a process that promotes thoughtful planning among patients, their care team, and their loved ones,” says Desh Mohan, MD, Koda's chief medical officer, in the post.

CareJourney was founded in 2014 in Arlington, Virginia.

"I'm hopeful next-generation quality measures will honor the patient’s voice in defining what it means to deliver high quality care, and our commitment is to measure progress on that important endeavor," noted Aneesh Chopra, CareJourney's co-founder and president.

Sports tech startup raises $500,000 pre-seed investment

BeONE Sports has created a technology to enhance athletic training. Photo via beonesports.com

Houston-founded BeONE Sports, an athlete training technology company, announced last month that it closed an oversubscribed round of pre-seed funding. The company announced the raise on its social media pages that the round included $500,000 invested.

Earlier in November, BeONE Sports completed its participation in CodeLaunch DFW 2022. The company was one of six finalists in the program, which concluded with a pitch event on November 16.

Space tech company snags government contracts

Graphic via cognitive space.com

The U.S. Air Force has extended Houston-based Cognitive Space’s contract under a new TACFI, Tactical Funding Increase, award. According to the release, the contract "builds on Cognitive Space’s work to develop a tailored version of CNTIENT for AFRL to achieve ultimate responsiveness and optimized dynamic satellite scheduling via a cloud-based API.

The $1.2 million award follows a $1.5 million U.S. Air Force Small Business Innovation Research award that the company won in 2020 to integrate CNTIENT with commercial ground station providers in support of AFRL’s Hybrid Architecture Demonstration program.

“The TACFI award allows Cognitive Space to continue supporting AFRL’s vitally important HAD program to help deliver commercial space data to the warfighter,” says Guy de Carufel, the company’s founder and CEO, in the releasee. “CNTIENT’s tailored analytics platform will enable HAD and the GLUE platform to integrate modern statistical approaches to optimize mission planning, data collection, and latency estimation.”

Houston airport powers up new gaming lounge for bored and weary travelers

game on and wheels down

Local gamers now have a new option to while away those flight delays and passenger pickup waits at Hobby Airport.

Houston's William P. Hobby Airport is now one the first airports in the country to offer what's dubbed as the "ultimate gaming experience for travelers." The airport has launched a premium video game lounge inside the international terminal called Gameway.

That means weary, bored, or early travelers can chill in the lounge and plug into15 top-of-the-line, luxury gaming stations: six Xbox stations, five Playstation stations, four PC stations, all with the newest games on each platform. Aficionados will surely appreciate the Razer's Iskur Gaming Chairs and Kraken Headsets, along with dedicated high speed internet at each PC station.

The Gameway lounge pays homage to gaming characters, with wall accents that hark to motherboard circuits Crucial for any real gamer: plenty of sweet and savory snacks are available for purchase to fuel up on those fantasy, battle, or sporting endeavors. As for the gaming console stations, players can expect high definition screens, comfortable seating, and plenty of space for belongings.

Make video games a part of your pre-flight ritual. Photo courtesy of Gameway

This gaming addition comes just in time for the holiday rush, when travelers can expect long lines, delays, and are already planning for extended time for trips. As CultureMap previously reported, Hobby will see a big boost in travelers this season — the largest since 2019. Now, those on a long journey can plug in, decompress, and venture on virtual journeys of their own.

Texan travelers may be familiar with Gameway; the company opened its first two locations at Dallas Fort-Worth Airport. The buzzy lounge an industry wave of acclaim: Gameway was awarded Best Traveler Amenity in 2019 at the ACI-NA Awards and in 2020, voted “Most Innovative Customer Experience” at the Airport Experience Traveler Awards, per press materials.

Two new locations followed in 2021: LAX Terminal 6 and Charlotte Douglas International Airport. The first of Gameway's Ultra lounge brand opened in September at Delta's Terminal 3 in LAX.

Gaming culture is a way of life in the Bayou City , which hosts Comicpalooza, the largest pop culture festival in Texas, and is home to several e-sports teams, including the pro esports squad, the Houston Outlaws.

A delayed flight never seemed so ideal for gamers flying out of Hobby. Photo courtesy of Gameway

“Gameway is the real reason to get to the airport early,” said Co-Founder Jordan Walbridge in a statement. “Our mission is to upgrade the typical wait-at-the-gate experience with a new stimulating, entertaining option for travelers of all ages.”

Here's guessing Hobby might just see an increase in missed or late flight arrivals — as travelers simply must beat those big bosses, solve puzzles, or win sports matches in the lounge.

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This article originally ran on CultureMap.