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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Register for some of these informative online events happening throughout the month of December. Getty Images

It's the last monthly events roundup for 2020 — and this month, understandably, is a bit slow due to the holidays, but we have a roundup of the must-attend events for December.

From workshops and panels to summits and pitch parties, here are over 10 Houston innovation events you can attend virtually via online meetings. Note: This post will be updated to add more events.

December 1 — National Resilience Town Hall: Year in Review, Year Ahead

The Insurance Information Institute and ResilientH2O Partners, in partnership with the Resilience Accelerator, will hold the final session for 2020 in an ongoing series of thought-leadership among insurance, non-insurance, public sector, and technology senior executives. December's National Townhall will bring five unique perspectives together to discuss lessons-learned from 2020 and predictions for 2021's resilience and risk mitigation "agenda" across residential, commercial, industrial, government operations, infrastructure, facilities, and communities.

The event is on Tuesday, December 1, at 10 am. It's free and can be accessed online. Click here to register.

December 1 — Angel Investing 101

Learn about how to make effective angel investment decisions and find out more about the newly launched Chicago Booth Angels Network of Texas. The event's keynote speaker is Ashok Rao, serial entrepreneur and board member of Houston-based GOOSE Capital.

The event is on Tuesday, December 1, from 5 to 6 pm. It's free and can be accessed online. Click here to register.

December 1 — The Ion's Industry Day

The goal of the inaugural Industry Day is to introduce and connect minority and women owned businesses (MWBE) with The Ion's Transwestern team. The hour long event is designed to facilitate networking and connect interested businesses with Transwestern, who will run operations for The Ion and catalyze local economic growth. Following the event, interested businesses can set up a walk through of The Ion in mid-December to finalize their bid.

The event is on Tuesday, December 1, from 6 to 7 pm. It's free and can be accessed through Zoom. Click here to register.

December 2 — NASA and Your Small Business: Understanding the NASA Procurement Process

Join The Ion to learn about NASA's commitment to providing access for all categories of small businesses to participate in the procurement process.

The event is on Wednesday, December 2, at noon. It's free and can be accessed through Zoom. Click here to register.

December 3 — Capital Factory's Venture Summit

Capital Factory is calling all investors, accelerator leaders, limited partners, and more to its annual venture summit, which is taking place virtually this year.

The event is on Thursday, December 3, from 9:45 to 2 pm. It's free and can be accessed online. Click here to register.

December 3 — Evening of Pediatric Device Innovation

JLABS @ TMC and Southwest National Pediatric Device Innovation Consortium are teaming up for the sixth Annual Evening of Pediatric Device Innovation. The evening of innovation will host top experts from Houston and across the country will discuss their views on the latest in pediatric medical device innovation and updates on bringing a pediatric medical device to market.

The event is on Thursday, December 3, from 3:40 to 5 pm. It's free and can be accessed through Zoom. Click here to register.

December 3 — An Evening With Women in Corporate Innovation

Join General Assembly Houston to hear from inspiring female leaders in corporate innovation who have blazed the path to stand up and stand out. From learnings to failings and their secrets of success, this event is an opportunity to learn from the best — serious wisdom, from seriously cool women, all designed to supercharge you and your organization's success.

The event is on Thursday, December 3, from 5 to 6:30 pm. It's free and can be accessed online. Click here to register.

December 8 — The Cannon Q4 Pitch Party: Presented by Dell Technologies

Join The Cannon and Dell Technologies in hearing from new companies working in Digital Transformation Tech.

The event is on Tuesday, December 8, at 5:30 pm. It's free and can be accessed via Zoom. Click here to register.

December 8 — How to Start a Startup with Heath Butler of Mercury Fund

The Ion is hosting a startup 101 workshop with Heath Butler from Mercury Fund. You have an idea...now what? Before you start looking for funding, it's important to make sure that your idea is both viable and valuable — if it doesn't have a sound model and a market willing to pay for it, investors won't be interested anyway.

    The event is on Tuesday, December 8, at 5:30 pm. It's free and can be accessed via Zoom. Click here to register.

    December 10 — Greentown Lab's Energy Bar: Wrapping Up an Unprecedented Year

    Join Greentown Labs virtually for the final edition of the EnergyBar networking event for 2020. Greentown Labs is ready to put a wrap on 2020, an unprecedent year for us all. Between the opening of the new community in Houston and a renewed national policy focus on climate action, the organization is looking ahead to 2021. Entrepreneurs, investors, students, and friends of climatetech are invited to attend, meet colleagues, and engage in a community that is focused on climate action at work.

    The event is on Thursday, December 10, from 3:30 to 6:30 pm. It's free and can be access through Remo. Click here to register.

    December 15 — The State of Space

    The Greater Houston Partnership is hosting its first State of Space event featuring NASA Administrator Jim Bridenstine as the keynote speaker. Since his appointment as Administrator in April of 2018, Bridenstine has led NASA in advancing American aeronautic, science, and space exploration objectives.

    The event is on Tuesday, December 15, at noon. It's $35 for GHP members and $60 for nonmembers. Click here to register.

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