In brief: Apple Watch, SOAR Act, Abbott Lingo, MAC consolidation 

CUPERTINO, Calif. – Apple on Sept. 9 unveiled Apple Watch Series 10, which among other things, features a new sleep apnea feature. 

Building on the intelligent health features already available to track key overnight metrics such as heart rate, respiratory rate and wrist temperature, the watch’s new sleep apnea feature can help identify signs of sleep apnea, the company says, by using the accelerometer to monitor small movements at the wrist that are associated with interruptions in normal respiratory patterns. 

“The sleep apnea notification algorithm was developed using advanced machine learning and an extensive data set of clinical-grade sleep apnea tests,” the company stated in a press release. “The feature was then validated in a clinical study — unprecedented in size for sleep apnea technology. In the clinical validation study, every participant identified by the algorithm had at least mild sleep apnea.” 

The company says a new Apple Watch metric, called Breathing Disturbances, can be used to help understand restfulness of sleep and, when occurring frequently over multiple nights, may be associated with sleep apnea. Users can view their Breathing Disturbances in the Health app, where they are classified as elevated or not elevated, and can viewed over a one-month, six-month or one-year period. 

Apple expects the feature to receive marketing authorization from the U.S. Food and Drug Administration and other global health authorities soon. The company says the sleep apnea feature will be available in more than 150 countries and regions this month, including the U.S., EU and Japan. 

CQRC: ‘We are optimistic’ 

WASHINGTON – With limited time remaining in the 118th Congress, the Council of Quality Respiratory Care is thanking new supporters of the SOAR Act and calling on the rest of legislators to join them in restoring patient access to all supplemental oxygen modalities. 

The new co-sponsors of S. 3821 and H.R. 7829 are:  

• Sens. Marsha Blackburn, R-Tenn., and Gary Peters, D-Mich. 
• Reps. Julia Brownley, D-Calif., Donald G. Davis, D-N.C., Cliff Bentz, R-Oregon, Darren Soto, D-Fla., Jahana Hayes, D-Conn., Zoe Lofgren, D-Calif., Rashida Tlaib, D-Mich., Deborah K. Ross, D-N.C., David J. Trone, D-Md., Alma S. Adams, D-N.C., Eleanor Holmes Norton, D-Washington, D.C., Marie Gluesenkamp Perez, D-Wash., Dean Phillips, D-Minn., Lori Chavez-DeRemer, R-Oregon, Chrissy Houlahan, D-Pa., Bill Posey, R-Fla., Michael Lawler, R-N.Y., and Juan  Ciscomani, R-Ariz. 

“We thank all Senate and House lawmakers who have cosponsored the SOAR Act and urge Congress to pass these measures for the nearly 1 million oxygen patients we deliver care to each year," said Jeff Barnhard, chair of the CQRC and CEO of Lincare. “We are optimistic that Congress will advance the SOAR Act through the appropriate committees and incorporate its vital reforms into policy before the year's end to ensure improved access to care for patients who need help breathing."   

S. 3821 now has four co-sponsors and H.R. 7829 has 20 co-sponsors. 

The SOAR Act would: 

• Remove supplemental oxygen from Medicare’s Competitive Bidding Program for durable medical equipment, 
• Ensure access to liquid oxygen for patients for whom it is medically necessary by establishing a separate payment system for liquid oxygen, 
• Permanently extend Medicare’s blended reimbursement rates, 
• Acknowledge and reimburse for essential respiratory therapy services, and 
• Require the use of a clinical template to eliminate the use of medical record notes to support patient access to supplemental oxygen. 

The CQRC is championing the bill with 30 stakeholders, including the American Lung Association (ALA), COPD Foundation, American Thoracic Society, American Association for Respiratory Care (AARC), the American College of CHEST Physicians, and Pulmonary Fibrosis Foundation. 

Abbott launches consumer biowearable 

ABBOTT PARK, Ill. - Abbott has announced the U.S. availability of Lingo, the company’s first glucose monitoring system available without prescription. 

The Lingo system includes a biosensor and a mobile app designed for consumers who want to improve their overall health and wellness, the company says. 

"There is a great deal of interest in tracking biomarkers that provide insights into one's health and wellness that were previously undetectable using the trackers available to consumers," said Olivier Ropars, divisional vice president of Abbott's Lingo business. "Glucose is a powerful signal of your body's unique response to food and lifestyle. Abbott's Lingo tracks your glucose 24/7, translating the data into insights and bridging the gap between traditional healthcare and preventative measures. Lingo empowers individuals to build new healthy habits and take control of their health and wellness." 

Lingo is based on Abbott’s FreeStyle Libre CGM technology, which is now used by more than 6 million people with diabetes globally. 

The system, which tracks glucose in real time and provides personal insights and coaching, is available for consumers 18 years and older not on insulin. Abbott announced in June that Lingo had been cleared by the U.S. Food and Drug Administration. 

• Earlier this year, Dexcom received clearance from the U.S. Food and Drug Administration for its Stelo by Dexcom, a continuous glucose monitor that will be available for people with Type 2 diabetes without a prescription. 

Mable Health buys DP&O 

HALIFAX, Nova Scotia – Mable Health has acquired Whitby, Ontario-based Design Prosthetics and Orthotics, further strengthening its presence in area and along the 401 corridor. Under the terms of the acquisition, DP&O shareholders will become shareholders of Mable Health and will continue to provide advanced prosthetic and orthotic services from their current location. "The acquisition of DP&O represents a key milestone in our Ontario platform,” said Michel Lanctôt, president of Mable Health. “DP&O's decades of experience and clinical excellence in orthotics and prosthetics will be invaluable as we continue our expansion across Canada, delivering exceptional care to those who need it most.” With more than 30 years of experience, DP&O provides patient-centered care, focusing on innovative solutions to improve mobility and overall well-being. Mable Health, which was formed in partnership with SeaFort Capital in early 2023, is focused on making investments and acquiring businesses in the orthotics, prosthetics, bracing and mobility aids industries.  

RedSail partners with NikoHealth 

MIDDLETOWN TOWNSHIP, N.J. – RedSail Technologies has announced a partnership with NikoHealth to elevate its service offerings for its HME pharmacy customers. As part of the partnership, RedSail’s customers will be introduced to the HME-focused features of the NikoHealth platform.  “For customers seeking a more HME-focused system, NikoHealth emerged as the preferred choice due to its next-generation, cloud-based HME system, which offers robust features that have garnered excellent customer feedback,” said Josh Howland, president of Pharmacy Management Systems at RedSail Technologies. “Key factors influencing our decision included NikoHealth’s rapid growth in the HME market and its modern, end-to-end solution with competitive pricing. We encourage everyone to connect directly with NikoHealth to explore these benefits further.” Features of the NikoHealth platform include order and inventory management, resupply, flexible open APIs and billing. 

• Read about NikoHealth’s growth in the HME industry. 

Lehan Drugs closes pharmacy 

DEKALB, Ill. – Lehan Drugs will stop providing pharmacy services at its DeKalb, Ill., location on Sept. 11, but it will continue to provide home medical equipment there, according to the Shaw Local News Network. The company, which launched in 1946, has multiple locations throughout the state but its only pharmacy was in Dekalb. It will also continue to provide HME at locations in Rockford, Freeport, Dixon and Aurora. “We’re proud of our long history serving the DeKalb community and how our family business has grown over the years to include pharmacy services and home medical equipment,” Lehan said in an email to Shaw Local News Network on Thursday. “Treating each of our patients with personal attention and care remains our standard and the hallmark of our family business.” Lehan Drugs will transfer its prescription services to Walgreens effective Sept. 12. In all, Lehan Drugs has six locations in Illinois and Wisconsin. 

Withings gets clearance for home sleep screening device  

BOSTON – Withings has announced that its Sleep Rx Mat has received clearance from the U.S. Food and Drug Administration, marking a new era in sleep diagnosis and paving the way to better health outcomes for millions of adults in the United States, the company says. Sleep Rx is an advanced sleep device clinically validated for use in the home screening of adults with suspected sleep breathing disorders as an aid for diagnosis for OSA, sleep analysis and heart rate estimation. The mat requires a one-time set up and fits under any mattress, eliminating the need for masks or other equipment. Once set up, it provides detailed analysis of sleep, breathing and cardiovascular activity throughout the night. The mat is available in the U.S. by prescription as part of clinical sleep management or remote patient monitoring programs. It can be acquired by health care professionals through Withings Health Solutions. FMI: www.withingshealthsolutions.com/connected-devices/sleep-rx. 

Inogen names Pauls to VP role 

He will help launch Simeox to US market 

GOLETA, Cailf. – Inogen has appointed Eric Pauls, formerly of Tactile Medical and Philips, as its vice president of sales, North America. “Eric’s extensive experience at Tactile Medical and Philips will be a powerful addition to our existing U.S. business-to-business and prescriber sales teams,” said Gregoire Ramade, chief commercial officer. “As we advance toward the introduction of Simeox to the U.S. market, Eric’s experience with the respiratory business will help us facilitate a strong and effective rollout.” Most recently, Pauls was chief customer officer at RQM+, a global company that provides specialized solutions to help medtech companies with the full product lifecycle, from concept to commercialization. Overall, he brings more than 20 years of executive sales and business development experience to help drive and support current and future growth. At Tactile, he was directly responsible for P&L management, business development, portfolio expansion and annual operating plan creation. At Philips, he was responsible for driving the annual operating plan, business development, sales excellence and operational compliance. “I am thrilled to join the dedicated and customer-focused team at Inogen,” said Pauls. “I look forward to utilizing my expertise in the respiratory segment to drive growth and deliver best-in-class products and service for respiratory patients and our customers.” 

• Read about Inogen’s acquisition of Physio-Assist SAS, a privately held company based in France that makes a technology-enabled airway clearance device called Simeox, for $32 million.   
• Read about the company’s efforts to prioritize its prescriber channel. 

Deal allows MTPS to expand LTC business, TwelveStone to focus on infusion 

SHELBYVILLE, Tenn. - Middle Tennessee Pharmacy Services has acquired the long-term care and MEDIpack service lines of TwelveStone Health Partners. The deal will enable MTPS to better serve residents in assisted living, skilled nursing and behavioral health communities, as well as individuals with intellectual and developmental disabilities and outpatient consumers, throughout Tennessee, southern Kentucky and northern Alabama. "We share TwelveStone’s commitment to exceptional customer service and care, and we're excited to build on their strong reputation serving senior living residents in the region," said Russ Spivey, co-president and founder of MTPS. "This acquisition enhances our ability to better serve LTC communities across Tennessee, and areas in Kentucky, and Alabama, and we look forward to integrating TwelveStone's talented team into our operations." Spivey and David Brown co-founded MTPS in 2005 and have steadily increased its footprint over the past 19 years, including with the opening of Guardian Mid-South Pharmacy in Memphis in 2012 and the launch of East Tennessee Pharmacy Services in Knoxville in 2013. This latest expansion will increase the company’s total customer base by 17%. The newly acquired pharmacy, located in Murfreesboro, Tenn., will continue to operate as TwelveStone, and all 34 employees there will join the MTPS team. For TwelveStone, the deal allows the company to narrow its focus on its rapidly growing infusion service business, which includes 21 centers in the southeastern U.S. across Georgia, Virginia, Kentucky and Tennessee. 

Abbott recalls certain sensors 

ABBOTT PARK, Ill. - Abbott has issued a recall for certain FreeStyle Libre 3 sensors due to a risk for inaccurate high glucose readings. On July 24, the company sent all affected customers an urgent medical device recall recommending they, among other things, immediately discontinue use and dispose of any affected sensors, and request a replacement for any affected seniors. Abbott initiated the recall after finding that a small number of FreeStyle Libre 3 sensors may provide incorrect high glucose readings, which, if undetected, may pose a potential health risk. The company says the use of affected product may cause serious adverse health consequences, including severe low blood sugar (hypoglycemia), which can cause central nervous system problems, loss of consciousness, seizures, coma, permanent brain damage and death. There have been two reported injuries and no reports of death. The recall affects UDI-DI 00357599818005/ Model No 72081-01 with lot numbers T60001948, T60001966 and T60001969. FMI: https://www.fda.gov/medical-devices/medical-device-recalls/continuous-glucose-monitoring-cgm-sensor-recall-abbott-diabetes-care-inc-issues-recall-certain. 

CMS proposes MAC changes 

WASHINGTON – CMS has posted a request for information to obtain public feedback on consolidating the Medicare Administrative Contractor (MAC) jurisdictions. The RFI also asks for feedback on awarding future MAC contracts with 10-year award periods of performance. The agency asks that those interested submit responses by email to MAC_Procurement@cms.hhs.gov within 30 days of the RFI publication date (Sept. 4). It says responses should be submitted as an email attachment in Microsoft Word and should be no longer than 15 pages. Use “Response to MAC Procurement RFI” in the subject line. FMI: https://sam.gov/opp/b551fa990aed4abea0d0cbce1e7eadc4/view.