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Vivos’ Oral Appliances Receive Full Approval for Medicare Reimbursement

The company’s CARE oral devices for sleep apnea are now eligible for Medicare reimbursement, broadening accessible treatment alternatives for beneficiaries.

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Seismic Shifts in the Sleep Therapy Landscape (Editor’s Message)

Tremblors from the Philips CPAP recall continue to shift the therapy landscape in sleep medicine.

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Oral Appliances Gain Ground in Severe Sleep Apnea Treatment

Vivos receives the FDA's first clearance for oral appliances to treat severe OSA, while ProSomnus accelerates its regulatory submission for a severe indication. A look at how these devices work, their efficacy, and what it means for patient care.

Vivos: Market Developments Position Company for Oral Appliance Therapy Growth

Feb 9, 2024 | Oral Appliances

Vivos highlighted certain market developments that it says are creating new opportunities to widen its funnel of potential users of Vivos’ oral appliance therapies.

FDA Reviews 510(k) Submission for ProSomnus Oral Appliance for Severe Sleep Apnea

Jan 30, 2024 | Oral Appliances

The FDA is in the process of reviewing the company’s premarket notification for its ProSomnus EVO oral device for the treatment of patients with severe obstructive sleep apnea.

ProSomnus: ‘Well-Positioned’ to Aid in Wake of CPAP Device Withdrawal

Jan 29, 2024 | Oral Appliances

Oral appliance therapy maker ProSomnus Inc announced its capability to support sleep apnea patients and sleep physicians affected by the discontinuation of certain CPAP devices.

FDA Clears OTC Mandibular Advancement Device for Snoring

Jan 25, 2024 | Oral Appliances

The device uses a molding method of being place in hot water to create a customizable fit for the user.

Vivos: FDA Clearance for Severe OSA Boosts Oral Appliance Interest

Jan 8, 2024 | Oral Appliances

Vivos announced it is seeing positive preliminary metrics after receiving FDA clearance for its CARE oral appliances to treat severe OSA.

UnitedHealthcare Mandates Oral Appliance Trial Before Sleep Apnea Surgery

Jan 8, 2024 | Oral Appliances, Reimbursement

UnitedHealthcare’s updated medical policy for obstructive and central sleep apnea establishes oral appliance therapy as a prerequisite therapy for surgical treatment in adult patients with moderate to severe OSA.

‘AGGA’ Inventor Testifies His Dental Device Was Not Meant for TMJ or Sleep Apnea

Dec 22, 2023 | Oral Appliances

A Tennessee dentist who has been sued by multiple TMJ and sleep apnea patients over an unproven dental device he invented has said under oath that he never taught dentists to use the device for those ailments—contradicting video footage of him telling dentists how to use it.

ProSomnus Oral Appliances Demonstrate Effectiveness in Treating OSA

Dec 19, 2023 | Oral Appliances

A recent study reveals that precision oral appliance therapy devices, developed by ProSomnus Inc, are effective in treating patients with obstructive sleep apnea.

apZme Acquires Sleep Impressions to Enhance Medical Billing in Dental Sleep Medicine

Dec 12, 2023 | Reimbursement

The acquisition aims to improve the landscape of dental sleep medicine by addressing a long-standing challenge in the industry: medical billing.

EPAP-Enhanced Oral Appliance Study Wins CHEST 2023 Top Abstract Award

Dec 5, 2023 | Oral Appliances

A clinical trial demonstrating the efficacy of an EPAP accessory used with an oral appliance for the treatment of obstructive sleep apnea was awarded the CHEST 2023 Top Abstract Poster Award.

Vivos Faces Q3 Revenue Dip Amid Global Sleep Apnea Sector Expansion

Nov 16, 2023 | Oral Appliances

Vivos Therapeutics reported a decrease in revenue for the third quarter, juxtaposed against its efforts to expand internationally and form strategic partnerships in the sleep treatment market.

Oral Appliance Maker ProSomnus Reports Record Q3

Nov 14, 2023 | Oral Appliances

ProSomnus Inc, a manufacturer of oral appliance therapy, reported record third-quarter revenue, marking its seventh consecutive quarter of revenue growth.

Lincare to Distribute Vivos Oral Appliances

Oct 24, 2023 | Obstructive Sleep Apnea, Oral Appliances

Vivos Therapeutics signed a US nationwide agreement with Lincare, a supplier of in-home respiratory therapy products and services, for the distribution of Vivos’ oral appliances.