Samsung Health Monitor app gains FDA approval for sleep apnea feature

Samsung Health Monitor app gains FDA approval for sleep apnea feature

Samsung Electronics has made significant strides in health technology, with its Samsung Health Monitor app receiving De Novo authorization from the U.S. Food and Drug Administration (FDA) for a pioneering sleep apnea feature. This authorization marks a milestone, as the feature is the first of its kind to be approved by the FDA, following its […]

Takeda halts TAK-994 narcolepsy treatment development due to hepatotoxicity concerns

Takeda halts TAK-994 narcolepsy treatment development due to hepatotoxicity concerns

Takeda’s pioneering Phase 2 trial of TAK-994, a potential treatment for narcolepsy type 1 (NT1), came to an abrupt halt due to hepatotoxicity concerns, according to a report published in The New England Journal of Medicine. This marks the termination of the TAK-994 program, despite the promising results of the oral orexin agonist on narcolepsy […]

Vivos Therapeutics DNA oral device gets FDA nod for obstructive sleep apnea

Vivos Therapeutics DNA oral device gets FDA nod for obstructive sleep apnea

Vivos Therapeutics has secured the US Food and Drug Administration (FDA) 510(k) clearance for its DNA oral device indicated for obstructive sleep apnea (OSA) treatment. The 510(k) approval for the DNA appliance as a Class II device marks the third FDA clearance for Vivos’ oral devices and the first clearance for the medical technology company’s […]

Axsome Therapeutics to acquire Sunosi from Jazz Pharmaceuticals

Axsome Therapeutics to acquire Sunosi from Jazz Pharmaceuticals

Axsome Therapeutics has agreed to acquire Sunosi (solriamfetol), an approved dual-acting dopamine and norepinephrine reuptake inhibitor (DNRI), from Jazz Pharmaceuticals. Sunosi is indicated to improve wakefulness in adults having excessive daytime sleepiness (EDS) because of narcolepsy or obstructive sleep apnea (OSA). The DNRI was approved in 2019 by the US Food and Drug Administration (FDA) […]

ResMed launches tube-up full face CPAP mask AirFit F30i

ResMed launches tube-up full face CPAP mask AirFit F30i

ResMed, a California-based medical equipment company, has launched AirFit F30i, a tube-up full face continuous positive airway pressure (CPAP) mask for patients with obstructive sleep apnea. With the launch, the company has completed its full face mask portfolio on the market. Full face CPAP users have options to choose from the type of connection either […]

ResMed acquires Korean home medical equipment provider HBH

ResMed acquires Korean home medical equipment provider HBH

ResMed acquisition of HBH : ResMed, a manufacturer of cloud-connected sleep and respiratory care devices, has acquired South Korea-based home medical equipment provider HB Healthcare (HBH) for an undisclosed price. HBH provides sleep and respiratory care devices to reimbursed and cash-pay customers in South Korea. ResMed plans to reach millions more patients through the Korean […]