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Waypoint Orthopedics Announces FDA Clearance of the Waypoint GPS

Waypoint Orthopedics Announces FDA Clearance of the Waypoint GPS

Waypoint Orthopedics Announces FDA Clearance of the Waypoint GPS
Waypoint GPS
The Waypoint GPS, Smart Gear Shift, and companion application.


MALVERN, Pa., May 15, 2023 (Newswire.com)
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Waypoint Orthopedics, Inc., a spinal medical device company, announces that the company’s Waypoint GPS™ – a smart bone awl for use during pedicle screw pilot hole drilling – has received 510k clearance from the U.S. Food and Drug Administration (FDA). 

The Waypoint GPS is a Smart Gear Shift™ that looks, feels, and acts like a standard bone awl while providing the operator with additional information via visual feedback. It utilizes proprietary color-sensing technology displayed wirelessly to an app-based operating system in real-time. The Waypoint GPS showed 100% operator interpretation cancellous, cortical, and breach during an in-vivo study. The device has the potential to increase surgeon confidence in pilot hole drilling while also potentially obviating the need for harmful ionizing radiation for all parties in the operating room. The system is indicated for use in both open and percutaneous (MIS) surgical approaches to the spine.

Dr. Andrew Cappuccino, an orthopedic spine surgeon, said: “The Waypoint GPS is a simple instrument that can ensure safety within the pedicle for the placement of pedicle screws. I believe that the integration of the Waypoint GPS helps to lower radiation exposure and save time in the accurate placement of pedicle screws.”

Jeffrey F. O’Donnell, Jr., President and CEO of Waypoint Orthopedics, said: “We are proud to announce the FDAs clearance of the Waypoint GPS. We firmly believe this product will become an everyday instrument for spine surgeons saving time, increasing confidence in screw placement, and adding layers of safety to every case regardless of approach. The Waypoint GPS has been designed to integrate easily into any workflow, all while providing the surgical team with information clearly and intuitively. As a Runway Healthcare portfolio company, we will look to transfer Waypoint Orthopedics to an existing commercial entity for wide-scale commercialization.” 

Dr. Stephen Banco, an orthopedic spine surgeon and co-founder of Waypoint Orthopedics, said: “The Waypoint GPS provides surgeons real-time feedback and confidence as they cannulate pedicles with incredibly simple and easy-to-use technology. I look forward to utilizing the Waypoint GPS in all of my instrumented fusions moving forward as an additional layer of safety and reliability.”

Waypoint Orthopedics is the first portfolio company of Runway Healthcare, LP, a MedTech accelerator fund. Runway Healthcare builds commercially ready opportunities for the medical device industry to acquire following regulatory approval. 

About Waypoint Orthopedics:

Waypoint Orthopedics, Inc. was founded to make vertebral fixation safer and more efficient for the patient, surgeon, and support staff. Waypoint Orthopedics’ product, the Waypoint GPS, uses proprietary color-sensing technology to inform the operator of the bone/tissue type change at the cutting edge of the awl. Waypoint Orthopedics’ controlling stockholder is Runway Healthcare, LP – a MedTech accelerator fund.

Inquiries: 

[email protected]

www.WaypointOrthopedics.com 

About Runway Healthcare, LP:

Runway Healthcare, LP is an early-stage MedTech accelerator. Runway Healthcare finances and manages the product development process of its portfolio companies. After navigating a portfolio company through the regulatory process, Runway Healthcare transitions the company’s ownership to a larger multi-national healthcare company for commercialization. Runway Healthcare is focused on early-stage technology in the Orthopedic, Cardiovascular, and Neurology sectors.

Inquiries:

[email protected] 

www.RunwayHC.com 

Forward-Looking Statements:

This press release contains “forward-looking statements” concerning the development of Waypoint Orthopedics products, the potential benefits and attributes of those products, and the company’s expectations regarding its prospects. Forward-looking statements are subject to risks, assumptions, and uncertainties that could cause actual future events or results to differ materially from such statements. These statements are made as of the date of this press release. Actual results may vary. Waypoint Orthopedics undertakes no obligation to update any forward-looking statements for any reason.

Contact Information:

Jeff O’Donnell

President & CEO

[email protected]

Original Source:

Waypoint Orthopedics Announces FDA Clearance of the Waypoint GPS

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Health News

Sarah Jacob Joins MedBridge Executive Team as Its First Chief Product Officer

Sarah Jacob Joins MedBridge Executive Team as Its First Chief Product OfficerJacob’s deep expertise will help the company define and lead a new path forward by expanding its footprint in digital patient care.

Sarah Jacob Joins MedBridge Executive Team as Its First Chief Product Officer
MedBridge Welcomes First Chief Product Officer Sarah Jacob
Image of Sarah Jacob with the words ‘MedBridge Welcomes First Chief Product Officer Sarah Jacob’


SEATTLE, May 11, 2023 (Newswire.com)
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MedBridge, the industry-leading digital health and online education solution for healthcare professionals and organizations across the care continuum, is excited to announce Sarah Jacob has joined the company’s executive team as its first Chief Product Officer.

Jacob has been a leader in the digital health technology space for over 10 years and is an expert at developing differentiated products and building world-class product organizations. With her considerable experience, skill, and talent, Jacob will help guide the future of MedBridge as the company continues to expand its digital patient care solutions designed to advance the healthcare industry through a time of rapid change.

With healthcare organizations under pressure to keep up with evolving patient needs, MedBridge has continued its ongoing commitment to building digital patient care solutions that support a more personalized healthcare experience. As the company’s growth accelerates, it has added new talent to the executive team and revised its web domain from medbridgeed.com to medbridge.com to reflect an expansion from education towards an increasingly more holistic digital care experience.

“The opportunity to join a world-class organization on a mission to change the way care is delivered to patients is incredibly exciting,” said Jacob. “MedBridge is uniquely positioned to engage patients in a way the industry hasn’t seen before, and I’m thrilled to be able to lead that effort. The products we are taking to market to blaze the trail for digital patient care will be industry-defining.”

MedBridge is the solution of choice for nine of the top 10 physical therapy private practices and hospital systems, and six of the top 10 home health agencies. Organizations leveraging the MedBridge Digital Care Ecosystem have already experienced striking results, including 69 percent better patient retention, 243 percent increased patient activation, and 27 percent better FOTO effectiveness scores. In overseeing MedBridge’s product management, design, and operations, Jacob will play a key part in building on and expanding these successes for the future of healthcare.

“With a large enterprise market presence that includes over half of the physical therapy market and partnerships with many leading healthcare organizations in the country, MedBridge is in a unique position to bring the value of therapy to more patients,” said Leigh Wager, Vice President, Strategic Solution at MedBridge. “We’re so pleased about the experience, passion, and product vision Sarah brings to the MedBridge team, our clients, and their patients. It’s an incredibly exciting time to be in healthcare.”

Contact Information:

Amelia Ramstead

Marketing Communications Manager

[email protected]

Original Source:

Sarah Jacob Joins MedBridge Executive Team as Its First Chief Product Officer

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