In brief: Prodigy responds to FDA, Sunrise launches program

Friday, September 6, 2013

CHARLOTTE, N.C. – Prodigy Diabetes Care has conducted a regulatory assessment by an independent auditor to examine, review and revise certain procedures and training to ensure compliance with FDA requirements, it told patients, caregivers and partners in a Sept. 4 letter.

“Prodigy assures you that this attention to improvement is an ongoing effort to ensure full compliance,” stated CEO Richard Admani in the letter.

In a Feb. 22 letter, the FDA warned Prodigy about numerous violations, including the company’s failure to notify the agency within 30 days of receiving complaints that its devices may have caused or contributed to a death or injury.

Admani states in the letter that, since February, Prodigy has reviewed all complaints received during 2011-13 and filed medical device reports or MDRs. Additionally, he pointed out that the complaints stem from the occasional “out-of-normal” readings that some patients experience from blood glucose monitors and that are not uncommon.

“Whether the cause be contaminated strips due to temperature, batteries, improper storage or handling of strips, or otherwise, all manufacturers receive reports that their devices ‘may have been a factor’ in an injury,” he states in the letter.

The FDA also warned Prodigy about its inspection of goods prior to release to customers. Admani stated in the letter that all test strips sent to patients meet FDA standards, and that in the wake of the warning, Prodigy has conducted additional testing of the lots in question and found all products were in line with federal standards.

“Prodigy’s goal is to provide accurate and reliable products at a good value,” he stated. “Just as important to us as the FDA’s input is feedback from persons who use our products day after day. We welcome your input and will work hard to address your concerns.”

Sunrise Medical launches compatibility program

FRESNO, Calif. – Sunrise Medical now guarantees product compatibility through a new program, the company announced Sept. 5. When customers order mobility products and seating systems through Compatibility Assurance, Sunrise will issue a single invoice and inspect the orders to ensure the components will work together properly. If not, the company will contact customers immediately to find a solution before the items ship. “By assembling the seating products and mobility base before shipping, we’re preventing what could cause a significant delay in getting the products to the consumer,” said Tim Morrison, product manager for Compatibility Assurance.

TSS auction approaches

NEW BRAUNFELS, Texas – The Scooter Store will auction off many of its assets at a Sept. 13 bankruptcy auction, according to news reports. The sale will take place at the company’s former New Braunfels, Texas, headquarters, where The Scooter Store employed more than 1,200 people before an FBI raid in February and a mass-layoff in March. About 200 employees relocated to a 30,000-square-foot location, also in New Braunfels. Among the items to be auctioned: computers, kitchen items and patio furniture.

Bard to acquire Rochester Medical

MURRAY HILL, N.J. – C.R. Bard and Rochester Medical, two players in the urology market, announced Sept. 4 that they have entered into an agreement to merge. The deal is expected to close later this year, with Bard paying $20 per share, about $262 million, for Rochester. “Rochester’s double-digit growth product portfolio, including their customer access programs, is a key building block in our strategy to access faster growing markets over the long-term,” stated Timothy Ring, Bard chairman and CEO, in a press release. “We believe that strengthening our position in the home care market, and specifically the large and fast-growing intermittent self-catheter segment, is strategically important at this time.” The merger has been approved by the directors of each company, and will be subject to regulatory approval and shareholder approval.

Numotion acquires Wheelchairs Plus

GRAND RAPIDS, Minn. – Numotion has acquired Minnesota-based complex rehab provider Wheelchairs Plus, the company announced Sept. 3. “Wheelchairs Plus is an established provider with locations in Grand Rapids and St. Cloud, Minn., providing quality equipment and services for all ages and needs for 37 years,” stated Christine Schedin, owner of Wheelchairs Plus, in a press release. “The equipment specialists will remain the same and we will continue to provide the excellent service our clients depend on.” The acquisition expands Numotion’s coverage and improves access to complex rehab technology for Minnesota residents, stated Timothy Havel, regional vice president.

Bruno sponsors ‘My Finish Line’ tour

OCONOMOWOC, Wis. – Vehicle lift manufacturer Bruno Independent Living Aids is now a major sponsor of the movie tour for “My Finish Line,” according to a press release. The film about paralyzed IndyCar driver Sam Schmidt is the subject of a 50-state movie and music tour raising money to give every disabled veteran in the country a DVD of the movie. Bruno provides more than 20 automotive lifts to suit a variety of vehicles. 

More veterans want help with sleep apnea, insomnia

FORT HOOD, Texas – An increasing number of veterans are seeking treatment at the Carl R. Darnall Army Medical Center for sleep apnea and insomnia. The hospital opened a sleep lab in 2012 and has already tested 600 patients, Lt. Col. Karin Nicholson, sleep services chief, told the Fort Hood Herald. Obstructive sleep apnea and insomnia are the most common disorders, she said. The increased number of cases is likely due to awareness, according to the article. Last year, 24,800 veterans began receiving compensation for service-connected sleep apnea, bringing the total to 114,000, at a cost of more than $1.2 billion a year, according to Stars and Stripes, a military news source.

China surpasses US in prevalence of diabetes, study says

CHICAGO – A new study suggests the prevalence of diabetes among Chinese adults has risen to 11.6%. Published Sept. 4 in the Journal of the American Medical Association, the study results show the percentage of Chinese adults with diabetes is now greater than the percentage of Americans adults with the disease. The American Diabetes Association says 11.3% of Americans 20 years old or older have diabetes. The study found those with diabetes in China tended to be older residents in more developed regions.

Integra Partners snags O&P contract

NEW YORK – Integra Partners now provides orthotics and prosthetics (O&P) to members of New York City’s Independence Care Systems (ICS), according to a Sept. 3 press release. ICS operates a nonprofit Medicaid managed long-term care plan in the city. It assists eligible adults with physical disabilities and chronic illnesses by coordinating care, housekeeping and other services, according to the release. Integra Partners is a healthcare network manager, connecting O&P and durable medical equipment providers with healthcare plans and patients.

Fewer than half sleep well, study finds

WASHINGTON – No matter where you live, a good night’s sleep is hard to find, according to the results of the Sleep Foundation’s 2013 International Bedroom Poll. Among adults ages 25 to 55 in six countries, half or fewer sleep well. The study, released Sept. 3, found Japanese and Americans get the least amount of sleep. “This groundbreaking poll suggests that chronic sleep deprivation is a significant global health problem,” said Russell Rosenberg, research director and investigator at NeuroTrials Research. The Sleep Foundation suggests that exercising regularly, maintaining a sleeping routine and banishing electronics from the bedroom can improve the quality of sleep. Every country—the United States, Canada, Mexico, the United Kingdom, Germany and Japan—sleeps in on the weekends.

Sanomedics finishes Prime Time buy

MIAMI – Medical technology holding company Sanomedics has completed its acquisition of Largo, Fla.-based Prime Time Medical Inc. for $3.1 million. “The completion of this acquisition marks a significant milestone in Sanomedics’ high-growth strategy of acquiring and integrating positioned medical equipment providers in today’s ever-demanding sleep apnea vertical,” stated Keith Houlihan, co-founder and president of Sanomedics, in a Sept. 3 press release. The acquisition was effective Aug. 30. Prime Time Medical provides mobility devices, respiratory equipment and diabetes supplies. Sanomedics says its goal is to purchase sleep therapy businesses to develop a portfolio of products and providers for the sleep apnea market, according to the release.

Patients in place for ResMed sleep apnea study

AMSTERDAM – More than 1,300 patients are signed up for a large study examining the outcomes of heart-failure patients using ResMed’s PaceWave to treat central sleep apnea. ResMed announced Sept. 3 that enrollment is complete for the randomized, international study called SERVE-HF. The study will determine whether Resmed’s Minute Ventilation ASV technology increases survival and reduces hospitalization of those with central sleep apnea. The technology monitors and stabilizes breathing patterns of those with sleep apnea, according to the release.

Aeroflow launches CPAP replenishment program

ASHVILLE, N.C. – With a new CPAP replenishment program, Aeroflow can help DME companies struggling under competitive bidding to serve patients more productively and cost-effectively, the company stated in a Sept. 3 press release. Aeroflow received contracts in 80 of the 91 areas included in Round 2 of competitive bidding. Through its fulfillment program, Aeroflow will contact patients to see what supplies they need, handle their paperwork, file their insurance and deliver products to their homes.

Short takes

U.S. Rehab, The VGM Group’s alliance for complex rehab providers, has announced a new vendor partnership with Conduit Technology, which offers a web-based software tool that reduces the time required to collect documentation. Conduit Technology also links to Brightree, another strategic partner of U.S. Rehab and VGM…The COPD Foundation announced Sept. 5 the launch of the COPD Pocket Consultant Guide, an iPhone app to make diagnosis and therapy for COPD easier and more effective in daily, clinical care. The app also allows healthcare professionals to interact with each other, and question and comment on the app…A Frost & Sullivan report estimates revenues in the Asian-Pacific wound-care market will grow at an estimated 6.9% through 2017, while the wound-closure market will grow at 7.5% through 2017. Released Sept. 5, the report says the increase of diseases such as diabetes and the influx of medical tourists are fueling the growth…Full-service mobility provider 101 Mobility is growing in West Virginia, opening retail markets in Clarksburg, Morgantown and Martinsburg, according to a Sept. 5 press release. The move expands 101 Mobility’s offerings beyond its existing Veterans Affairs contract in the state.