NEWS
ALIGN TECHNOLOGY RECEIVES FDA CLEARANCE FOR THE INVISALIGN PALATAL EXPANDER SYSTEM TO ADDRESS SKELETAL AND DENTAL EXPANSION IN GROWING PATIENTS
Align Technology , a leading global medical device company that designs , manufactures and sells the Invisalign System of clear aligners , iTero intraoral scanners and exocad CAD / CAM software for digital orthodontics and restorative dentistry , has announced that the US Food and Drug Administration ( FDA ) has cleared Align ’ s Invisalign Palatal Expander System for commercial availability in the US . The FDA clearance is for broad patient applicability , including growing children , teens and adults ( with surgery or other techniques ).
Previously introduced at the Align Technology Investor Day in September 2023 , the Invisalign Palatal Expander System is a modern and innovative direct 3D printed device based on proprietary and patented technology . Invisalign Palatal Expanders are intended for use in rapid expansion and subsequent holding of skeletal and / or dental narrow maxilla ( upper jaw ) with primary , mixed or permanent dentition during treatment of patients . The Invisalign Palatal Expander is Align ’ s first direct 3D printed orthodontic device and provides a safe and comfortable alternative to traditional palatal expanders that require manually turning a screw in the device in the mouth daily to achieve expansion .
“ The Invisalign Palatal Expander System worked very well clinically , we had fewer emergencies and less chair time than we did with traditional expanders ,” said Dr Don Spillers , an orthodontist and participant in an Invisalign Palatal Expander clinical trial . “ The experience has definitely been much better for my patients with the Invisalign Palatal Expander System , as there was no cementing of bands , no fitting of a metal expander and no screw to turn . All of the parents were happy and their kids were cooperative .”
BIDEN-HARRIS ADMINISTRATION LAUNCHES HUB FOR MEDICAID / CHIP RENEWAL AND TRANSITION RESOURCES
The US Department of Health and Human Services ( HHS ), under the Biden-Harris Administration , has launched a new online hub to support access to quality health coverage .
This user-friendly resource focuses on Medicaid and Children ’ s Health Insurance Program ( CHIP ) renewal and transition . Consolidating materials from various federal sources , the hub aims to facilitate partners in the renewal process . Developed primarily by the
Centers for Medicare & Medicaid Services ( CMS ), it includes resources from different HHS and US Government agencies . This initiative aligns with the Administration ' s commitment to ensuring individuals with Medicaid or CHIP coverage stay informed about state renewal processes .
The central hub plays a crucial role in the comprehensive strategy to enable easy renewal or transition to alternative coverage options through employment or Affordable Care Act Marketplaces .
The collaborative effort reflects a holistic government approach to assist those renewing or transitioning their health coverage .
HHS Secretary , Xavier Becerra said : “ We encourage our partners to utilise this new resource hub to help ensure children and families have the coverage that ’ s right for them . We also urge states to join us in partnering with local governments and community organisations to reach people eligible for Medicaid and CHIP where they are . �
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