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In brief: MSC and Trace Medical make buys, FDA extends EUA 

In brief: MSC and Trace Medical make buys, FDA extends EUA 

CLEVELAND – Medical Service Company has acquired OhioHealth Home Medical Equipment in Central Ohio. 

“Through its three community locations and several in-hospital offices and liaisons, OhioHealth HME supports lightning-fast discharges for the OhioHealth hospital network,” MSC stated in a press release. 

MSC has also entered a long-term partnership with the OhioHealth health system, which comprises a family of 35,000 associates, physicians and volunteers, and a network of 14 hospitals, 200-plus ambulatory sites and hospice, home health and other facilities spanning 47 counties in the state. 

Last fall, MSC announced it had acquired ProMedica Home Medical Equipment in Northwest Ohio and Southeast Michigan. 

MSC has 650 employees and 45 locations that support DME-related discharge planning services for 44 partnering hospitals and more than 160,000 patients annually.  

Trace Medical buys Bio-One 

WHITMORE LAKE, Mich. – Trace Medical has acquired Bio-One, a factory authorized biomedical services company also based in Michigan. 

“Bio-One has been an essential partner to Trace over several years of exponential growth,” said Greg Apostolou,” CEO of Trace Medical. “The integration of Bio-One will create a seamless internal service and maintenance process, and more importantly, will provide a compelling service solution to the provider community.” 

Bio-One is the second biomedical services company that Trace Medical has acquired in the first quarter of 2023, following Medequip Service Solutions based in Greenbrier, Ark., in February. 

Trace Medical also recently announced an exclusive agreement with VGM & Associates to provide advanced respiratory equipment rentals and biomedical services to its 3,000 provider members.  

Trace Medical, VGM expand partnership 

WHITMORE LAKE, Mich. – Trace Medical has executed an exclusive program agreement with VGM & Associates to provide its membership of 3,000 providers with advanced respiratory rentals and biomedical services. 

“VGM and Trace have worked seamlessly together since 2018 in our collective support of the home medical equipment market,” said Elliot Campbell, chief commercial officer of Trace Medical. “Continued alignment with VGM helps ensure our expanding value propositions are available to as many providers as possible while supporting the industry as a whole through VGM’s legislative efforts. Moreover, as we rapidly expand nationally into biomedical services, VGM’s support will be paramount in our ability to provide biomedical services nationally – something the industry desperately needs.” 

The agreement goes into effect April 1. 

Trace Medical announced in 2022 that it was on the precipice of a large expansion of its business, preparing to add biomedical services for a number of respiratory products to its offerings. It then announced earlier this year that it had acquired Medequip Service Solutions in Greenbrier, Ark., a factory authorized equipment repair services company. 

“Our relationship with Trace Medical has been very beneficial to our membership,” said Jeremy Stolz, president of VGM. “We look forward to their expanded solutions including biomedical services and are confident that it will serve the provider community well. The Trace team have demonstrated the ability.”  

FDA extends EUA for vents, other devices 

Agency also publishes final guidance for transition 

WASHINGTON – The U.S. Food and Drug Administration has announced in the Federal Register that the Emergency Use Authorization for certain ventilators and PAP and RAD devices will be in effect until Nov. 7, 2023, 180 days beyond the end of the public health emergency on May 11. 

The EUA, which was issued under separate authority from the PHE, allows for certain vents, PAP and RAD devices to be used by patients, even though they haven’t gone through the formal FDA clearance process. During the pandemic, the EUA was issued to help address a spike in demand for the devices and ease strains on the supply chain. 

After Nov. 7, manufacturers will have to go through certain FDA processes to allow those devices to be used by patients.  

The FDA on March 24 published final guidance on those processes: 

Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency 

Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19)

The FDA’s draft guidance was posted for stakeholder feedback in December 2021. 

Medtrade attendees vote on best new products 

DALLAS – Miracle Mobility in Clearwater, Fla., won the Gold Award at the New Product Pavilion at Medtrade for its 4N1 Electric Walker Wheelchair. Belluscura won the Silver Award for its DISCOV-R Portable Oxygen Concentrator, and Motif Medical won the Bronze Award for its Aura Breast Pump. The awards are sponsored by HomeCare Magazine. Medtrade took place March 28-30 at the Kay Bailey Convention Center in Dallas. 

Sleep Solutions patients see benefit of V-Com 

DETROIT – Sleep Solutions, an HME provider based here, recently completed a trial of 100 patients starting CPAP therapy, with 50 patients receiving standard care and 50 patients receiving standard care with the V-Com device. The provider found 12% more of those using V-Com group met the 90-day CMS requirement for adherence. “Most importantly, this is wonderful for the health of our patients,” said Robyn Parrot, president of Sleep Solutions. “But these results also improve the health of our company – fewer mask exchanges, happier patients and more resupply. I think everyone’s adherence rates dropped during COVID. Ours did. But this is great news.” Sleep Solutions also performed a patient preference survey. During set up, new patients were allowed to experience CPAP therapy at their prescribed pressure both with and without V-Com in their CPAP circuit. In a follow-up survey, 98% preferred the V-Com in their circuit and 98% believed the device would give them a better chance of long-term adherence. SleepRes, which makes the V-Com, has similar data to Sleep Solutions. “Having an independent, third-party medical company have similar outcomes provides further validation of V-Com’s benefits to patients and medical equipment companies.” 

ACU-Serve, Nymbl partner 

AKRON, Ohio – ACU-Serve has signed an agreement with Nymbl Systems to “fill the void for purpose-built automation systems” specifically for complex rehab technology providers. “As the CRT industry continues to grow, we see more of our CRT-oriented customers struggle with business systems that don’t meet their needs – from both a front-end, intake perspective and a back-office, billing perspective,” said Jim Knight, CEO of ACU-Serve. “Nymbl brings a fresh approach to addressing the needs of CRT providers, with its roots deeply embedded in the O&P practices where many of the same challenges existed until Nymbl came along.” Columbus, Ohio-based Nymbl works with hundreds of CRT, O&P and HME providers.   

Philips launches virtual care portfolio 

AMSTERDAM – Royal Philips has launched Philips Virtual Care Management, a comprehensive portfolio of solutions and services to help health systems, providers, payers and employer groups more meaningfully motivate and deeply connect with patients from virtually anywhere. “Virtual care is paving the way to meaningfully reduce the cost of care through fewer hospitalizations and emergency department visits,” said Nick Wilson, general manager, Ambulatory Virtual Care, at Philips. “Care providers and health systems today are often short on time and resources, accelerating the need to find new ways to gain visibility into patients’ health amid an overwhelming variety of options. For patients, the opportunity to understand and take proactive control of their health can potentially lead to improved outcomes.” Philips Virtual Care Management’s condition-specific protocols now include diabetes, hypertension, heart disease, chronic kidney disease and chronic obstructive pulmonary disease (COPD), as well as gestational programs for diabetes and hypertension. The company says these protocols combine with connected devices and engagement tools on a secure, interoperable cloud-based platform to deliver rich data and actionable insights that enable timely intervention and workflow efficiencies. Recent studies using Philips Virtual Care Management solutions and services demonstrated positive results, including a 38% average reduction in emergency department visits and an average HbA1c, or blood glucose, reduction of 3.06%. 

Numotion adds former congressman to board 

BRENTWOOD, Tenn. – Numotion has announced that Jim Langevin, the former Rhode Island congressman, has joined its board of directors. Numotion says as part of the board, Langevin will leverage his vast experience in shaping strategic change, driving technology innovation and cybersecurity, and advocating for people living with disabilities to strengthen Numotion. “We are excited to welcome Congressman Langevin to our board of directors,” said Mike Swinford, CEO. “He brings a unique perspective as a wheelchair user, advocate and policymaker that will help frame the direction of Numotion to better serve our customers. I am very excited to have this opportunity to learn from Jim and have him contribute to our future direction.” Langevin is the first quadriplegic to serve in the U.S. House of Representatives and was instrumental in the passage of the ADA Amendments Act. In addition to representing Rhode Island as a congressman from 2001-23, he has also served as the RI Secretary of State and as a member of the RI General Assembly. 

Kit Shellhouse joins van Halem Group 

ATLANTA – Kit Shellhouse, formerly of ECS North and ACU-Serve, has joined the van Halem Group, a division of VGM Group, as director of business development. Her duties will include managing key partnerships, generating new clientele, fostering relationships and building the van Halem Group brand. “I have known and worked with Kit for over 15 years,” said Wayne van Halem, president of the van Halem Group. “She is a widely recognized thought leader in our industry, and I am proud to have her on our team.” Shellhouse, who has more than 20 years of experience in the HME industry, will continue to participate in and present at industry events and trade shows, including Medtrade.  

VGM receives language learners grant 

WATERLOO, Iowa – VGM Group was one of 11 employers awarded the Iowa Language Learners Job Training Program Grant on March 8 to develop solutions to reduce language barriers for Iowa-based companies. With the grant, VGM will provide high quality on-site language training in focused groups totaling up to 144 employees over the two-year grant period. “We’re incredibly grateful that VGM has this opportunity to take the necessary steps to develop this program,” said VGM Chief People Officer Sara Laures. “Not only will this benefit and support our current employee owners, but this opens the door for bringing in more highly qualified talent.” VGM was awarded the full grant requested of $163,500, the most of the 11 recipients. The company anticipates continuing the program for years to come, in addition to helping other companies develop a similar program to support their employees. 

Inogen adds Tom West to board 

GOLETA, Calif. – Inogen has named Tom West to its board of directors effective April 1. “We are pleased to welcome Tom West to the Inogen board,” said Elizabeth Mora, who chairs the board. “Tom brings additional general management and operational experience to the Inogen board with his history of leadership and business success in medical technology and life sciences health care spaces.” West serves as president and CEO, as well as executive director of the board, of Nalu Medical, a medtech company focused on neurostimulation to treat chronic intractable pain. Before Nalu, he served as president, CEO and director at Intersect ENT, which was acquired by Medtronic in May of 2022. West served as an independent member of the board of directors of the public traded company Orthofix from 2021 to 2023. “I am thrilled to have the opportunity to advance Inogen’s transformation into a global respiratory care leader,” said West, who will join the Compliance Committee and the Governance Committee of the board. “Inogen has been an industry innovator. I look forward to adding my operating experience accelerating growth opportunities to help the company enhance the value it delivers to its patients, customers and shareholders.” Inogen also announced that Kristen Miranda will retire from the board effective March 31. 


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