Braebon DentiTrac FDA Cleared for Use with Airway Management TAP Devices.
Braebon’s DentiTrac oral appliance compliance system is now FDA cleared in the United States for use with the Airway Management Inc TAP family of oral devices.
DentiTrac is a wearable microrecorder and web cloud portal combination that provides objective measurement of oral appliance compliance measurement for sleep apnea. It is an integrated wearable microrecorder embedded inside an oral appliance to reliably and accurately gather detailed information to confirm a patient is following prescribed therapy. The information is then uploaded to the Braebon cloud portal where physicians and dentists can conveniently and securely review patient information and assess sleep apnea therapy adherence.
“We are very pleased DentiTrac is expanding its footprint in the US market. Accurate oral appliance compliance measurement is needed to level the playing field with traditional sleep apnea treatment called CPAP,” says Richard Bonato, PhD, RPSGT, Braebon CEO and co-founder, in a release. “In addition, the ability to reliably measure sleep apnea treatment adherence is a vital requirement for insurance payers. Oral appliance therapy for obstructive sleep apnea is the number-one alternative to CPAP and we anticipate this will contribute to significant overall growth in the burgeoning field of dental sleep medicine and the use of oral appliance therapy for sleep apnea. The DentiTrac is the final realization of the Braebon Test Treat Trac strategy, which empowers clinicians across multiple disciplines to efficiently and collaboratively work together to more effectively manage the sleep apnea patient.” Editor’s Clarification: Though many payors do require compliance tracking for CPAP devices for patients beginning treatment, Sleep Review is not aware of any payors that require compliance tracking for oral appliances at this time. Check directly with your patients’ payors for the most accurate information on what is required for an oral appliance to be covered by patients’ medical insurance.
Donald Bradley, CTO and co-founder, says, “The challenge was to develop a measurement technology which could not be easily deceived. This was vital because new US Federal DOT legislation will impact everyone in the transportation industry including all truck drivers, pilots, bus drivers, etc. We had to invent a novel and powerful solution, which we’ve secured with IP patent protection. The level of product sophistication connected with our cloud portal is beyond anything we’ve done before. I’m very proud of what our team has accomplished.” Editor’s Clarification: New legislation regarding the transportation is being discussed currently but is only in the early stages. For more information on potential future regulation, read “8 FMCSA Rulemaking Myths Debunked.”
Airway Management founder Keith Thornton, DDS, says, “Airway Management has an agreement in place with Braebo. We look forward to working closely together to roll-out TAP with DentiTrac to target markets in the USA, and subsequently to the rest of the world.”
