Oral Examination Device and Intraoral Camera: TelScope Telehealth System Registered with FDA, TGA, and CE Marked

Holland Healthcare’s newest telehealth device and intraoral, TelScope Telehealth System, is now registered as a Class 1 Medical Device with the FDA, registered with the TGA, and is CE Marked.

The United States Food and Drug Administration (FDA) classifies Class 1 Medical Devices as devices with low or moderate risk to patient safety.  TelScope Telehealth System is registered with the FDA as a system, meaning that both the TelScope device and the TelScope App are registered with the FDA.

The Australian Therapeutic Goods Administration (TGA) is Australia’s governing body for therapeutic goods, including medical devices, in Australia. TelScope Telehealth System is registered with the TGA as a system. Once again, this means that both the TelScope device and the TelScope App are registered with the TGA.

Finally, TelScope is now CE Marked. The Certification Mark indicates that “conformity with health, safety, and environmental protection standards for products sold within the European Economic Area (EEA). The CE marking is also found on products sold outside the EEA that have been manufactured to EEA standards.” As with the FDA and TGA, TelScope Telehealth System is CE Marked as a system, meaning both the TelScope device and the TelScope App are CE Marked as per the EEA.

It is important to remember that the TelScope Throat Scope single-use depressors are registered for single-use only by the FDA. Throat Scope depressors attach to the TelScope Telehealth System as an illuminating tongue depressor to complete an oral telehealth exam. The Throat Scope single-use depressors are designed to reduce risk of cross-contamination. They come individually-wrapped, and they should not be cleaned and reused. The single-use depressors are recyclable, so we encourage you to recycle them after use. ♻️

To preorder TelScope Telehealth System, click here.

Download the TelScope App:

Get it on Google Play

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Telehealth Tuesday: Doing a Teledentistry Exam – with Dr. Richard Simpson, DMD

Dr. Richard Simpson, DMD, is a pediatric dentist in private practice.

Dr. Richard joined Holland Healthcare founder and medtech inventor of TelScope Telehealth System intraoral examination device and intraoral camera, Jennifer Holland, to discuss teledentistry and more.

The teledentistry team discussed

  • What is teledentistry?
  • Why is it important? What are its benefits?
  • Why is teledentistry especially important in today’s climate?
  • Plus a live demonstration of an at-home dental consultation via teledentistry using TelScope Telehealth System.

ABOUT THE HOSTS

Dr. Richard Simpson, DMD, is a board certified pediatric dentist in private practice.
His achievements include:
• Diplomate in the American Board of Pediatric Dentistry
• Fellow in the American College of Dentists
• Fellow in the International College of Dentists
• Fellow in the American Academy of Pediatric Dentistry
• Advisory Board Member of The TeleDentists
• Advisory Board Member of Holland Healthcare
Dr. Richard’s experience and active interests include telehealth, child advocacy, health disparities, policy, and advancing improved medical-dental access to care. Dr. Richard is also a veteran with 15 years of military service.

 

 

 

 

 

Jennifer Holland is the inventor of TelScope Telehealth System. She is the CEO and founder of Holland Healthcare, as well as the inventor of Holland Healthcare’s first product, Throat Scope illuminating oral examination device and tongue depressor.

TelScope Telehealth System is the oral examination device that also transforms any smart device into a high quality intraoral camera for telehealth and teledentistry.