In brief: Resmed cleared for smart settings, Perry Bernocchi promoted, Lingo access expanded 

SAN DIEGO – Resmed has received clearance from the U.S. Food and Drug Administration (FDA) for an artificial intelligence (AI)-enabled device that recommends personalized comfort settings to help people with obstructive sleep apnea (OSA) start and stay on CPAP therapy.  

Personalized Therapy Comfort Settings (PTCS), which will be marketed as Smart Comfort, will launch in early 2026 in a limited beta version in the United States for new users of myAir paired with AirSense 11, followed by a broader rollout later in 2026. 

“For people new to CPAP therapy, personalized comfort settings can help them adjust faster and more comfortably, improving confidence and overall health,” said Justin Leong, chief product officer at Resmed. “Smart Comfort’s FDA clearance marks an important milestone for the future of personalized, data-driven care. It’s another example of how we’re using technology and real-world evidence to make sleep health more personal, accessible and effective.” 

Resmed says the FDA submission was supported by retrospective real-world evidence showing that Resmed AirSense 10 and 11 users whose comfort settings matched Smart Comfort recommendations had higher engagement and sustained therapy adherence compared to those using default settings.  

Why is Smart Comfort needed 

Resmed says addressing common therapy issues, like comfort and mask fit, early can promote long-term adherence. Smart Comfort leverages the company's proprietary machine-learning algorithms, drawing on more than 100 million nights of de-identified, real-world sleep data and user information, such as age, gender and Apnea-Hypopnea Index (AHI), to recommend individualized comfort settings for CPAP therapy delivered by AirSense 11 devices. These include settings that help ease users into therapy, adjust how gradually an AirSense 11 increases pressure and reduce pressure on exhale.  

What it means for providers 

Resmed says Smart Comfort offers a solution to help streamline user setup and follow-up and reduce manual adjustments so clinicians can devote more attention to clinical decision-making and patient support. By getting people engaged in their therapy from day one, Smart Comfort helps standardize the comfort settings workflow and builds user confidence that their settings are personalized for them. These non-prescription comfort settings are designed to support CPAP therapy device usage – not alter prescribed therapy settings or therapy efficacy. 

Sen. Jim McGovern seeks coverage for medical foods, formulas 

WASHINGTON – Rep. Jim McGovern, D-Mass., has introduced the Medical Foods and Formulas Access Act to require Medicare, Medicaid, the Children’s Health Insurance Program and the Federal Employees Health Benefit Program to cover specialized formulas, vitamins, individual amino acids and other medically necessary foods prescribed by a physician for patients with specific gastrointestinal and inherited metabolic disorders. The bill would ensure state and federal protection for existing coverage. 

“Access to health care is a human right—no one should have to worry about whether they'll be able to access the medically necessary food they need to live,” said McGovern. “I’m disgusted by the stories I hear from many of my constituents who are struggling to get medically necessary food for their child or family member because predatory insurance companies are refusing to cover prescribed foods and formulas just to pad their bottom line. Our bill breaks down barriers to care and ensures that Americans with inherited metabolic diseases or gastrointestinal conditions get the nutrition they need.” 

Joining McGovern in introducing the legislation: Sens. Roger Wicker, R-Miss. Amy Klobuchar, D-Minn., Sheldon Whitehouse, D-R.I., and Chuck Grassley, R-Iowa, and Reps. John Rutherford, R-Fla., and Debbie Dingell, D-Mich. 

Reasons for why the bill is needed include: 

• Nearly 40 states require coverage of medically necessary nutrition, but coverage is highly variable from state to state.   
• Approximately 2,000 infants every year are diagnosed with an inherited metabolic disorder through the newborn screening program. When these conditions are left untreated in both children and adults, food can become toxic, or the body can fail to absorb necessary nutrients.   
• Risks in pediatric populations are particularly profound and include inadequate growth, abnormal development, cognitive impairment, and behavioral disorders. These individuals must turn to medically necessary nutrition, such as highly specialized formulas, both as a treatment for their condition and as sustenance. These conditions cannot be solely managed by avoiding certain foods.  Specialized medically necessary nutrition prescribed by a health care provider is standard-of-care treatment for these patients and is essential to healthy development. 

For full text of the legislation, click here.   

Owens & Minor names Bernocchi EVP & COO 

RICHMOND, Va. - Owens & Minor has appointed Perry Bernocchi executive vice president and COO, according to a Form 8-K filed with the U.S. Securities and Exchange Commission. Since March 2023, he has served as executive vice president and CEO of the company’s Patient Direct segment. Earlier this year, Owens & Minor signed a definitive agreement to sell its Products & Healthcare Services (P&HS) segment, in a move that the company said supports its transformation into a pure-play home-based care platform, centered around its Patient Direct business. Edward Pesicka is the president and CEO of Owens & Minor. The company will also eliminate the role of chief human resources officer (CHRO), following the departure of Jennifer Stone on Dec. 31. Heath Galloway, executive vice president, general counsel and corporate secretary, will add oversight of the human resources function to his current responsibilities. 

• Related: Owens & Minor rebrands to sharpen focus on home-based care. 

Soleo Health to broaden rare disease portfolio with new exec 

FRISCO, Texas – Soleo Health has appointed Jody Thompson as senior vice president of business development, rare disease, to broaden the company’s portfolio of exclusive and limited distribution therapies for rare, ultra-rare and orphan diseases. By building key partnerships, Thompson will amplify Soleo Health’s established rare disease expertise to focus on this small, underserved population facing some of the most complex health care challenges, the company says. “Jody’s wealth of experience and leadership in successfully commercializing life-changing therapies will be instrumental as we expand our portfolio of rare and orphan therapies,” stated Drew Walk, Soleo Health CEO. “Soleo Health has been dedicated to supporting patients with rare and orphan diseases since our inception, and this strategic role underscores our ongoing commitment to our pharma, payor, provider partners and the patients we serve together.” Rare, ultra-rare and orphan diseases affect fewer than 200,000 people in the U.S., nearly half of whom are children, according to Soleo Health. Thompson joins the company with an extensive background as a pharmaceutical health care executive and a proven track record of successfully commercializing multiple rare disease products in the U.S. Prior to joining Soleo Health, she held key leadership roles in market access, patient support and huge services, with a focus on rare diseases. “I’m excited to join Soleo Health and advance its mission of delivering rare disease therapies to patients who need them most,” said Thompson. “We have an incredible opportunity to make a meaningful impact on patient care and outcomes.” 

• Related: Earlier this year, Soleo Health promoted Holly Flax to COO.   

Abbott expands access to Lingo CGM & app 

ABBOTT PARK, Ill. - Abbott has announced that Lingo, an over-the-counter continuous glucose monitor (CGM) and app, is now available for Android devices. Already available for Apple iOS devices, the company says this expansion gives millions more people access to real-time glucose data, empowering informed choices that help support better energy, sleep, focus and overall well-being. "The need for more glucose awareness is clear," said Amy McKenzie, Ph.D., head of Medical Affairs for Abbott's Lingo business. "Prediabetes – a condition where glucose is elevated but not yet in the diabetes range – impacts more than 98 million U.S. adults, yet 80% of those affected don't know they have it. With awareness and lifestyle changes, prediabetes can be managed or reversed. Lingo provides the insight needed to help people understand their glucose patterns in real time, empowering informed choices that support better metabolic health." The Lingo app is now available for download for Android through the Google Play Store and continues to be available for iOS on the Apple App Store. Lingo can be purchased at hellolingo.com, Amazon, and in-store and online at Walmart. 

• Related: Abbott launches consumer biowearable. 

AAOE gives Breg Vision its seal of approval 

CARLSBAD, Calif. - The American Alliance of Orthopaedic Executives (AAOE) has awarded its Peer Reviewed designation to the Breg Vision DMEPOS workflow management platform. The designation follows AAOE’s 11-step evaluation, including end-user surveys and a detailed product review. "Having spent my career across this space, I know what the market offers, and what it lacks,” said Steve Ingel, president, Breg, Inc. “What we are building with Breg Vision is different. It's smarter, more adaptable, and backed by the strongest customer support infrastructure in the industry. Earning the AAOE Peer Reviewed designation reinforces what I hear from customers every day: Breg Vision is the platform of choice for practices that refuse to settle for 'good enough.'" Breg Vision’s features include Vision Clarity, which automates benefits verification and delivers real-time out-of-pocket estimates; and enterprise-grade security, including SOC 2 Type 2, MFA and SAML 2.0. 

Lifeway Mobility further expands presence in Mid-Atlantic 

HARTFORD, Conn. - Lifeway Mobility has opened a new location in Ashburn, Va., to serve residents across the greater Washington, D.C., area, including northern Virginia and select areas of the eastern part of the state. The new location further extends the company's reach across the Mid-Atlantic, building on its well-established location in Baltimore. It will also allow Lifeway Mobility to quickly expand throughout the state of Virgina in the coming months. “We’re thrilled to bring Lifeway Mobility’s services to Washington D.C. & Northern Virginia,” said Nathan Colburn, DVP at Lifeway Mobility. “Our goal is to make it easier for residents to live safely and comfortably in their homes, and our local team is excited to reach new customers with personalized mobility solutions to enhance their daily lives.” Local offerings in the Washington, D.C., metro area will include stair lifts, wheelchair ramps and lifts, and transfer aids. Earlier this month, Lifeway Mobility opened a new location in Nashville. 

• Related: Lifeway Mobility stretches along I-95 corridor. 

Permobil adds CIO to Group Management team 

LEBANON, Tenn. - Permobil has elevated its information technology (IT) function to the company’s highest leadership level. Katrin Blixt, CIO since 2019, now joins Permobil’s Group Management team and reports directly to CEO Chuck Witkowski. “Katrin has been instrumental in driving our IT strategy over the last decade,” Witkowski said. “Her passion and grit have helped us unlock new capabilities across the company, from digital tools that support our customers to modernizing our digital infrastructure. As we now intensify our digital transformation, her leadership will be pivotal as a member of group management to ensure information technology and data is embedded in every strategic decision we make.” Permobil says the move reflects the company's strategic decision to fast-track its digital evolution, encompassing upgrades to core infrastructure and the incorporation of cutting-edge innovations such as artificial intelligence (AI). The company's goal: enhance operational agility, deepen customer and end user connections and propel its core mission of creating a future free from mobility limitations. “I’m excited to bring IT into the heart of our strategic decisions,” Blixt said. “Technology is not just an enabler – it’s a catalyst for innovation. Our focus will be on building smarter, more secure solutions, harnessing AI, and empowering teams to collaborate in new ways. This progress will redefine how we deliver value globally – and ultimately create even greater independence and possibilities for our users.”   

Study: Health care workers say technology important factor in job satisfaction 

OVERLAND PARK, Kan. - Persistent staffing shortages, high turnover and escalating burnout are intensifying pressures across the care continuum, prompting demand for technology that drives greater efficiency, according to a workforce study released by WellSky. Ninety percent of nurses and health care professionals surveyed identified care coordination technology as valuable to the quality and efficiency of their work. Many also pointed to electronic health records and artificial intelligence (AI) as valuable tools, signaling a growing expectation for intelligent systems that streamline workflows and enhance care delivery, the company says. “Healthcare is at a turning point – one that calls for bold innovation,” said WellSky Chairman and CEO Bill Miller. “We’re building solutions where technology feels effortless, data flows intelligently, and clinicians can devote their energy to healing rather than paperwork. With AI and predictive analytics at the center, we’re driving a future of care that’s faster, smarter and deeply personalized.” The report, conducted by the global research firm The Center for Generational Kinetics, draws on industry trends and data from WellSky’s national network of more than 2,500 hospitals, accountable care organizations (ACOs and physician practices, as well as 130,000 post-acute, home and community care providers. Other highlights from the report: 

• 83% say health care workers shoulder an unfair burden for the problems facing today’s health care system 
• 69% of nurses say AI would be valuable to their job 
• 77% of nurses say software technology that they like or are familiar with is an important factor when choosing a job