BELLEFONTE, PA, August 17, 2023 – For over 16 million Americans grappling with neurological conditions like stroke, Parkinson’s, and paralysis, a groundbreaking solution is on the horizon to lost restore function. Brain computer implants hold the promise of restoring lost function. But they have a major challenge because the human body treats these implants as foreign bodies which triggers a response that limits the implant’s working lifetime. Actuated Medical’s innovative SonoShield™ Defender uses precisely engineered sound waves to help minimize this foreign body response. Early testing demonstrated the promise of the technology to extend implant working lifetime. To enable continued SonoShield Defender development, Actuated Medical, Inc. has been awarded a $2.2 million Fast-track Phase II Small Business Innovative Research (SBIR) project from the National Institutes of Health-National Institute of Mental Health (NIH-NIMH). Actuated plans to unveil the SonoShield Defender at the Neuroscience 2023 Conference, November 11-15, 2023 in Washington, DC.
“Our commitment to advancing medical technology is poised to make a lasting impact on the lives of millions. The SonoShield Defender has the potential to decrease the foreign body response that plagues many implanted medical devices. Commercialization of the technology will enable a future where neurological conditions are met with enhanced solutions that improve quality of life.” Maureen L. Mulvihill, Ph.D., Actuated Medical President, CEO, and Co-Founder expressed her excitement about the immense potential of this technology.
Advancing Healthcare Practices of Clogged Tube Management: The TubeClear System Launches an Online Training Course
BELLEFONTE, PA, August 3, 2023 – Actuated Medical is excited to announce the introduction of the TubeClear Online Training Course, now available at TubeClear.com. The TubeClear System, a patented medical device, helps Healthcare Practitioners maintain indwelling feeding tubes. These tubes play a crucial role in delivering life sustaining medication, nutrition, and hydration to patients who are unable to tolerate oral feedings due to conditions such as brain injury, Alzheimer’s, Parkinson’s, or stroke.
Recognizing the time constraints faced by healthcare professionals, Actuated Medical developed the TubeClear Online Training Course. The course equips Practitioners with the necessary knowledge and skills to effectively utilize the TubeClear system within a shorter timeframe. By doing so, Practitioners can maintain patients’ feeding tubes so that their life sustaining medication, nutrition, and hydration are delivered without disruptions, as prescribed.
“Actuated Medical’s team strives to improve patient outcomes with innovative medical devices. Our TubeClear system has been used by early Practitioner adopters for about 10 years, with no adverse events reported. This online training will expand the number of TubeClear proficient Practitioners beyond early adopters, leading to more effectively managed feeding tubes for a greater number of patients. This will result in improved outcomes for feeding tube patients,” expressed Maureen L. Mulvihill, PhD., Actuated Medical President, CEO, and Co-founder and TubeClear System Co-inventor.
Since 2013, the TubeClear System has consistently demonstrated its effectiveness in clearing sluggish and clogged feeding tubes, surpassing the performance of competing solutions in terms of speed and efficacy. The online training course covers aspects of the device and its functionality plus the setup procedures. The training allows Practitioners to train at a time convenient to them. Upon successful completion of the training course, Practitioners will receive a certificate recognizing their commitment to advancing their expertise in feeding tube management. The certificate can be given to the Practitioner’s institution as verification of training completion.
For more information on the TubeClear Training Course, please visit: https://www.tubeclear.com/courses/tubeclear-training/.
Actuated Medical Hosts Celebration of Innovation with Impact, Showcasing Expanded Facilities and Next-Generation Medical Devices
BELLEFONTE, PA, July 19, 2023 – Actuated Medical held a Celebration of Innovation with Impact on May 11, 2023 at their new HQ in Bellefonte, PA. The event began with a ribbon-cutting of their new 20,000 sq.ft. innovation center. Afterwards, over 80 attendees including Pennsylvania Representatives Kerry Benninghoff and Paul Takac, Centre County Commissioners Mark Higgins and Amber Concepcion and representatives from Governor Josh Shapiro, Senator Bob Casey, and Senator John Fetterman’s offices, had the opportunity to meet the Actuated Team and learn about their cutting-edge medical device innovations.
“Our expansion marks a significant milestone, empowering our team to continue delivering groundbreaking medical device innovations that improve patient outcomes,” said Maureen L. Mulvihill, President, CEO and Co-founder.
The event also showcased local food and beverage entrepreneurs such as Big Spring Spirits, Barrels & Kegs (by Mark Grello), and Delectable Delights by Heather. In addition, Discovery Space, the local children’s museum showcased their offerings for STEM education programs.
About Discovery Space
Discovery Space of Central Pennsylvania is an exciting growing science center of interactive exhibits and hands-on programs designed to provide valuable informal science education, especially in the areas of Science, Technology, Engineering, and Math (STEM), in a fun learning environment. Discovery Space provided collaborative yarn art project for the attendees at the Celebration.
For more information, please visit https://discoveryspace.org/
About Big Spring Spirits
With an emphasis on local, Big Spring Spirits founder Kevin Lloyd envisioned opening a community-centric craft distillery in the heart of Central Pennsylvania. When the opportunity arose to set down roots in Bellefonte’s beautiful Match Factory in 2014, it was an easy decision. Since then, Big Spring Spirits is proud to be able to a partner with this community, sourcing from the local farmers and artisans, whenever possible. Big Springs Spirits provided taste testing of wonderful, fruity spirits for the Celebration.
For more information, please visit https://www.bigspringspirits.com/
About Barrels & Kegs
Barrels & Kegs is an emerging company founded by Mark Grello. They showcased their selection of wines and beers through sample tastings as part of their initial marketing efforts at the Celebration.
About Delectable Delights by Heather
Heather Luse has been baking for as long as she could reach the wooden spoons. She is guided by old-fashioned baking wisdom. She takes the science of baking and combines it with the artistry of decorating, bringing it all together to coordinate and beautifully complement weddings, parties and events. Heather displayed beautiful and tasty cupcakes at the Celebration.
For more information, please visit https://delectabledelightsbyheather.com/
BELLEFONTE, PA, February 17, 2023 – The FDA has issued a 510(k) Clearance for the Shippert Tech Intraosseous Safety Sheath. As a Critical Care physician, Dr. Brian Shippert has seen colleagues accidentally stick themselves while removing interosseous (IO) needles from patients. While using a winged cork screw, he realized a design solution to this serious needle stick problem. Shippert patented the Intraosseous Safety Sheath (IOSS). In 2019, he contracted with Actuated Medical to develop the IOSS medical device. The Actuated Medical Team refined the device, performed FDA required testing, wrote and submitted the FDA 510(k) premarket application. The IOSS received clearance (K220890) in October 2022.
Intraosseous needles are inserted into bone to infuse fluids quickly when vascular access is difficult. These needles carry high risk of accidental needle sticks as they are often troublesome to remove from the bone matrix. The IOSS device encloses around the IO needle prior to removal then acts as a protective cover as the IO needle is pulled out of the bone. The IOSS is indicated for use with 25mm or 45mm EZ-IO vascular access needles. Shippert Tech is contracting with Actuated Medical on the next phase of making the IOSS available to hospital systems.
“We teamed with Dr. Shippert to realize his dream of making the IO needle easier to remove and safer than currently available methods for clinicians. We are excited to see this medical device available to clinicians,” said Maureen L. Mulvihill, President and CEO of Actuated Medical.
“I took my patent to Actuated Medical and they have been very thorough. They completed the development, wrote and submitted the FDA 510(k). Because of the Actuated Medical team and their expertise, my patent is an FDA cleared medical device,” Brian Shippert, DO, Critical Care Physician, Shippert Tech, LLC.
Actuated Medical Awarded NIH Phase I and Phase II Exploratory/Developmental Grants for Wearable Deep Vein Thrombosis (DVT) Sensors
Deep vein thrombosis (DVT), a subset of venous thromboembolism, is a condition in which blood clots form deep within peripheral veins, typically in the lower extremities. This disease can cause swelling, vascular damage, and pain. More critically, when clots dislodge and travel through the blood stream they may lodge in lung, heart, or brain vessels and lead to death. Though medications are available to mitigate risk, there are few options for chronic or continuous monitoring. This project develops a wearable approach for monitoring at-risk patients for DVT formation.
“Having a lightweight, low cost DVT sensor that can be easily worn is important for the quality of care for surgical patients that are at a higher risk for DVTs. There are many other applications where a flexible sensor would improve patient outcomes which makes the market potential for this technology very large” said Maureen L. Mulvihill, Actuated Medical President, CEO, and Co-Founder.
“We are pleased to build the healthy and productive academia-enterprise partnership for technology translation and commercialization, which creates clear pathways for our device innovation to reach the marketplace and benefit public health” said Dr. Huanyu “Larry” Cheng, Associate Professor of Engineering Science and Mechanics, at The Pennsylvania State University.