In brief: AAH analyzes NIV data, Roche enters CGM market 

WASHINGTON – AAHomecare is leading an effort to quantify the differences in outcomes and overall treatment costs for patients with significant respiratory challenges who receive non-invasive ventilation (NIV) therapy versus those who don’t. The research will help to determine the benefits of this therapy using CMS’s own data, potentially providing authoritative data to underpin advocacy to strengthen patient access to NIV, the association says. “This important effort stems from discussions at last year’s Board Strategic Planning Session on how we can limit delays and denials for patients who can benefit from NIV,” said Tom Ryan, AAHomecare president & CEO “Our leaders believe this is an area where credible data on outcomes and overall costs will make a strong impression on policymakers and payers.” AAHomecare has engaged Dobson Davanzo & Associates to conduct research and analyze results. They will involve respiratory stakeholders, including clinicians and HME industry experts, to further develop cohorts and provide oversight. The association says work will begin next week, and the project is expected to be completed in about 10 months. 

• This research is the latest effort by stakeholders to curb denial rates for NIV. They have also partnered with patient advocacy groups like the ALS Association to ask CMS to clarify policy and coverage.  

RRI issues new product catalog 

ST. LOUIS – Responsive Respiratory has released a new Product Solutions catalog for oxygen. The catalog highlights RRI’s newest entry into the oxygen analyzer market, the O2 Checker, and its commitment to high-pressure oxygen products. “The O2 checker is unique in today’s oxygen market,” said Steve Bannon, president. “The user-intuitive interface allows technicians to transition seamlessly between equipment types and features a simulated breath function to detect and measure output efficiently.” The catalog is a complete respiratory resource guide for the home health care, hospital and EMS markets, and features new value-add items like Boost Oxygen and portable oxygen analyzers, and updated disposables like concentrator humidifier adaptors to help round out RRI’s offerings. The catalog is available by request in both electronic and print format. 

EnsoData expands access to clinical data 

MADISON, Wis. – EnsoData has acquired sleep testing diagnostic technology from Resonea, adding acoustic flow and microphone data channels to its platform as a new way to use a mobile application to pre-screen patients for sleep apnea and extend the diagnostic capabilities of home sleep testing. These two new channels use a U.S. Food and Drug Administration-cleared app to record auditory data during sleep, securely transfer that data to the cloud and enable breath-by-breath analysis of respiratory flow and snoring to identify events indicative of sleep apnea or other disorders. “We are very excited to bring both acoustic flow and microphone data to the sleep community to expand the clinical data available for the health systems and providers utilizing PPG-based sleep testing,” said Justin Mortara, EnsoData CEO. “This is another step toward simplifying access to sleep care, helping to get more patients with sleep disorders diagnosed and, ultimately, connected with therapy. As a leader in health care AI solutions, EnsoData’s device agnostic approach using pulse oximeters (PPG) and now smartphones supports our strategy to deploy flexible solutions that can easily scale to address the unmet clinical needs for sleep testing in the U.S. and globally.” EnsoData expects to make the new capabilities commercially available in the U.S. this year. 

Roche receives CE mark for CGM 

BASEL, Switzerland – Roche has received the CE Mark for its Accu-Chek SmartGuide continuous glucose monitoring (CGM) solution. This significant milestone paves the way for the solution to be made available to people living with Type 1 and Type 2 diabetes who are over the age of 18 and who are on flexible insulin therapy. “Maintaining optimal blood glucose levels and preventing adverse glycemic episodes remains a complex task for people living with diabetes, often necessitating up to 180 therapy decisions a day,” said Matt Sause, CEO of Roche Diagnostics. “Our novel CGM solution with its predictive algorithms will help address significant unmet needs associated with diabetes management, empowering users to take control of their condition and live better and healthier lives.” The Accu-Chek SmartGuide CGM sends glucose values measured in real time to the Accu-Chek SmartGuide app. The app then uses those values and other available information to detect glucose patterns and predict future glucose levels. Its integrated AI-enabled predictive algorithms indicate hypoglycemia risk within the next 30 minutes, continuously forecast how glucose levels will develop within the next two hours and estimate the risk of nocturnal hypoglycemia. 

Inspire recalls implantable pulse generator 

MINNEAPOLIS, Minn. – Inspire Medical Systems is voluntarily recalling its Inspire IV Implantable Pulse Generator (IPG) Model 3028 due to a manufacturing defect that can cause system malfunctions after implantation, leading to electrical leakage in the sensing circuit. As a result, patients may need revision surgery to replace the IPG and restore therapy. There have been no reported injuries or death.