EarlyBird got the worm

Houston medical device company gains FDA approval

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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Building Houston

 
 

So many Newstonians are coming in from California. Photo courtesy of TxDOT

The Hollywood-to-Houston population pipeline is overflowing, a new study suggests.

Harris County ranks as the No. 1 destination for people relocating to Texas from California, according to a StorageCafé data analysis. The No. 1 place of origin? Los Angeles County, home to Hollywood.

Among California counties, Harris County attracted the most new arrivals from Los Angeles County in 2019 (3,263), followed by San Diego County (840), and Riverside County (698).

Why are Californians swapping the West Coast for the Gulf Coast? A prime reason appears to be housing costs. The analysis shows the median price difference in 2020 between a home in Los Angeles County and a home in Harris County was $482,010. And even though they're paying less for a home in Harris County, L.A. transplants are gaining a median 577 square feet in additional space.

"When housing prices in California go up, so does migration to Texas. When housing prices in California go down, migration to Texas goes down as well," William Fulton, director of Rice University's Kinder Institute for Urban Research, tells StorageCafé, a self-storage platform.

Looking at the California-to-Texas connection, Los Angeles County holds the top seven spots in the ranking of counties that send the most new residents to our state. Here are the top seven:

  1. Los Angeles County to Harris County (3,263 new residents in 2019).
  2. Los Angeles County to Dallas County (2,492 new residents in 2019).
  3. Los Angeles County to Travis County (2,060 new residents in 2019).
  4. Los Angeles County to Collin County (1,609 new residents in 2019).
  5. Los Angeles County to Tarrant County (1,374 new residents in 2019).
  6. Los Angeles County to Bexar County (1,366 new residents in 2019).
  7. Los Angeles County to Denton County (1,290 new residents in 2019).

"Elon Musk is well on his way to being the first human on Mars, but he's far from being a pioneer when it comes to moving to Texas. His recent move to the state is just one among the almost 190 daily moves from California to Texas that occurred from 2010 to 2019," StorageCafé says.

Here are the top 10 counties for new arrivals from all California counties in 2019:

  1. Harris County — 8,408.
  2. Dallas County — 7,923.
  3. Travis County — 6,725.
  4. Tarrant County — 6,623.
  5. Bexar County — 5,340.
  6. Collin County — 5,294.
  7. Denton County — 4,028.
  8. Williamson County — 2,877.
  9. El Paso County — 2,521.
  10. Bell County — 1,727.
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This article originally ran on CultureMap.

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