2023 FDA  Approved Devices

CALCIVIS Imaging System 

Calcivis imaging system can assist dentist for identifying and treating caries lesions or tooth decay. The system comprises a syringe applicator and a portable imaging device with a camera. The CALCIVIS photoprotein solution, that is designed to highlight active caries lesions in the pictures, is delivered via a syringe applicator.

Implications for usage:

1. Dental healthcare practitioners should use the Calcivis Imaging System on patients (6 years and older) who have or are at risk of developing demineralization linked to caries lesions on coronal tooth surfaces that are easily accessible. 
2. As a tool for assessment, diagnosis, and treatment planning of demineralization related to caries lesions, the Calcivis Imaging System is approved for use in providing images of active demineralization on tooth surfaces. 

Positioning

The CIS provides dentists a way to take and maintain pictures of tooth surfaces that have labelled free calcium ions, which is consistent with demineralization in active caries. This gives dentists the chance to put caries management techniques into practice. A definitive diagnosis of caries cannot be made solely based on the CIS pictures. They ought to be taken into account when creating a patient's care plan and comprehensive diagnostic workup. 

When is it used?

Dental practitioners are the intended users of the CALCIVIS Imaging System for patients aged 6 and above who have current caries lesions on their tooth surface that are causing mineral loss of enamel or who are at risk of developing such lesions.

What is it that it seeks to achieve?

Dental professionals can analyze, diagnose, and treat caries lesions that may become cavities with the aid of the system's photographs. The CALCIVIS Imaging System clinical research quantified the presence or absence of visible light originating from the CALCIVIS photoprotein on tooth surfaces. Next, based on the International Caries Detection and Assessment System (ICDAS), the study evaluated the degree to which the data correlated with measurements of teeth made by dentists.

CALCIVIS Imaging Device Kit Consists of: 

•  CALCIVIS Intra-oral Imaging Device 
• CALCIVIS Device Cradle 
•  CALCIVIS (Imaging) Software on USB card 
•  CALCIVIS User Manual  

Fig 2:shows the CALCIVIS Imaging Device loaded and assembled on a stand. 

Fig 3:An illustration of a typical "demine-map" image displayed chairside by the CALCIVIS imaging system.

Images were taken of 90 healthy teeth with no obvious lesions and 86 teeth with active caries lesions out of 110 individuals who underwent imaging with the CALCIVIS Imaging System. Eighty-eight of the ninety-nine sound teeth without obvious lesions also did not release light from photoprotein, indicating a 97.8% agreement.

FDA approved : 2023

Applicant: CALCIVIS pvt ltd.

REFERENCES

1. https://www.fda.gov/medical-devices/recently-approved-devices/calcivis-imaging-system-p170029
2. https://www.accessdata.fda.gov/cdrh_docs/pdf17/P170029B.pdf
3. https://www.accessdata.fda.gov/cdrh_docs/pdf17/P170029C.pdf

 

Paper2: Cochlear Implantation in Children with Congenital Inner Ear Malformations

The prospective study conducted by Azzam Muhsin Abbas et al, in the paper Cochlear Implantation in Children with Congenital Inner Ear Malformations (conducted from 2018 to 2021) aim of the paper was to assess issues and surgical challenges that patients who received cochlear implantation and had a congenital inner ear abnormality faced. It has stated in the paper that a controversial is present to perform cochlear implantation in children with inner ear anomalies because ears that are born deaf may have anatomical abnormalities that make the procedure more challenging.

                           The study was conducted at the Department of Otolaryngology Medical City Teaching Complex and AL-Yarmouk Teach-ing Hospital, Baghdad, Iraq, where they had 21 pediatric subjects diagnosed with congenital hearing loss and had an implantation. CT was performed on the subject in order to check CSF leakage and facial nerve damage on the subject to point out on the challenges faced after the surgery. The paper was concluded with the In certain cases of congenital inner ear defects, individuals can have a cochlear implant placed safely and effectively. In some cases, with gusher and facial nerve anomalies, surgery might be difficult, but problems can be avoided with appropriate imaging and skillful surgical technique.

Reference :

Cochlear Implantation in Children with Congenital Inner Ear Malformations Craig A. Buchman MD, Benjamin J. Copeland MD, PhD, Kathy K. Yu MD, Carolyn J. Brown MS, CCC-SLP, Vincent N. Carrasco MD, Harold C. Pillsbury III MD

 Paper1: 

Effects of Age at Implantation on Outcomes of Cochlear Implantation in Children with Short Durations of Single-Sided Deafness

Karen A. Gordon et al, aim described in the paper Effects of Age at Implantation on Outcomes of Cochlear Implantation in Children with Short Durations of Single-Sided Deafness (study conducted between May 2013 to June 25, 2021) was to help children with single sided deafness with a cochlear implant in order to improve the hearing. As a study was conducted in the paper regarding that they stated 3/1000 ratio of children are affected from unilateral impairment and children who is having a severe impairment is categorized as SSD and the need for the cochlear implant among the SSD children as there were very less subjects who received this implants also the timing of the implantation to be effective is considered.

                                The study was conducted under the Research Ethics Board of this institution where they had a participation of 57 subjects between the ages of 2 to 12 years with prelingual and post lingual aspects. The subject where implanted with nucleus CI and provided with auditory –verbal therapy. As for the first test speech was presented as recorded or live voice at 60 to 65db  in a silent and noise environment and for the next they analyzed the ability of the subject to differentiate between moving and stationary localization as the 12 subject were made to sit near the motors and adjustable no swivel stool. As the result of the study it was stated that CI provided more hearing to children than in adolescents. They concluded stating the advantages of CI for children with short SSD durations are more obvious for young kids getting CIs than for older kids and teenagers.

Reference:

 Gordon KA, Alemu R, Papsin BC, Negandhi J, Cushing SL. Effects of Age at Implantation on Outcomes of Cochlear Implantation in Children with Short Durations of Single-Sided Deafness. Otol Neurotol. 2023 Mar 1;44(3):233-240. doi: 10.1097/MAO.0000000000003811. Epub 2023 Jan 14. PMID: 36728258; PMCID: PMC9924958.

Stress And Life (infograph poster)