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The company behind a global recall of sleep apnea machines said Monday it will stop selling the devices in the U.S., under a tentative agreement with regulators that could cost the manufacturer ...
The health regulator added that in 2023, between July and September, it received more than 7,000 medical device reports, including 111 reports of deaths related to the use of these machines.
The AIO Breathe Device is a “new mandibular repositioning device” that was designed by local sleep physician Dr. Raghavendra V. Ghuge, MD, MBA, DABSM, […] FDA clears Tyler company’s device ...
Philips Respironics's products include devices for the diagnosis and treatment of sleep apnea including CPAP and bi-level non-invasive ventilation machines, oxygen concentrators for patients requiring supplemental oxygen, infant apnea monitors for infants at risk of SIDS, asthma treatment solutions and hospital ventilators.
Halo-gravity traction (HGT) is a type of traction device utilized to treat spinal deformities such as scoliosis, [1] [2] congenital spine deformities, cervical instability, basilar invagination, and kyphosis. [3] It is used prior to surgical treatment to reduce the difficulty of the following surgery and the need for a more dangerous surgery.
The following are settlements reached with US authorities against pharmaceutical companies to resolve allegations of "off-label" promotion of drugs. Under the Federal Food, Drug, and Cosmetic Act, it is illegal for pharmaceutical companies to promote their products for uses not approved by the Food and Drug Administration (FDA), and corporations that market drugs for off-label indications may ...
Also, limited head movement while on CPAP is desired to optimize oxygen flow in and out of the device. Cervical soft collars are used to try to achieve both of these goals. In a small study analyzing the use of cervical collars in patients on CPAP ventilation with a history of sleep apnea, a significant benefit was observed. [25]
Per court documents seen by PEOPLE, Angela Moan is suing Sleep Number Corporations and Leggett & Platt Incorporated — who designed, manufactured, marketed, sold and warrantied the bed — after ...