Capture.JPGAcuvue Oasys Contact Lenses with Transitions Light Intelligent Technology 

Johnson & Johnson Vision care

USE: Soft Contact lenses that automatically darkens the lens when exposed to bright light. Indicated for daily use to correct the vision of people with non-diseased eyes who are nearsighted (myopia) or farsighted (hyperopia).

ADDRESSING UNMET NEED:  First contact lens to incorporate the same technology that is used in eyeglasses that automatically darken in the sun

DESCRIPTION:

  • Contains photochromic additive that adapts the amount of visible light filtered to the eye based on the amount of UV light to which they are exposed
  • Results in slightly darkened lenses in bright sunlight that automatically return to a regular tint when exposed to normal or dark lighting conditions. 

SAFETY AND EFFECTIVENESS:

  • Clinical study of 24 patients that evaluated daytime and nighttime driving performance while wearing the contact lenses
  • No evidence of concerns with either driving performance or vision while wearing the lenses
  • May cause inflammation or infection in or around the eye or eyelids 

REGULTORY PATHWAY: 510(k)

  • Classification: II
  • Regulation No. : 886.5925
  • Classification Product Code: LPL
  • Subsequent Product Code: MVN

REIMBURSEMENT

  • Medicare provides limited coverage for contact lenses under Medicare Vision Services
  • Acuvue Brand covered by private payors

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IDx-DR Retinal diagnostic software device

IDx LLC

INDICATION FOR USE: For use by health care providers to automatically detect more than mild diabetic retinopathy (mtmDR) in adults diagnosed with diabetes who have not been previously diagnosed with diabetic retinopathy. IDx-DR is indicated for use with the Topcon NW400.

ADDRESSING UNMET NEED:

  • Diabetic retinopathy is the most common cause of vision loss among the more than 30 million Americans living with diabetes
  • Leading cause of vision impairment and blindness among working-age adults
  • First medical device to use Artificial Intelligence (AI) to detect greater than a mild level of the eye disease diabetic retinopathy in adults who have diabetes

DESCRIPTION:

  • Software program using AI to analyze eye images taken with retinal camera, Topcon NW400
  • Doctor uploads digital images of retinas to cloud server with IDx-DR software
  • Software provides doctor with one of two results
    1. “more than mild diabetic retinopathy detected: refer to an eye care professional”
    2. “negative for more than mild diabetic retinopathy; rescreen in 12 months.”
  • If positive result – further diagnostic evaluation and possible treatment as soon as possible

GENERIC DEVICE TYPE: Retinal diagnostic software device.

Prescription software device that incorporates an adaptive algorithm to evaluate ophthalmic images for diagnostic screening to identify retinal diseases or conditions.

ACCURACY & PRECISION:

  • Clinical study of retinal images, n=900 patients with diabetes, 10 primary care sites
  • Correctly identify presence of more than mild diabetic retinopathy: 87.4%
  • Correctly identify patients who did not have more than mild diabetic retinopathy: 89.5%

IDENTIFIED RISK & MITIGATION MEASURE:

  • False positive results leading to additional unnecessary medical procedures (Diagnostic algorithm failure, Software failure): Clinical performance testing;
    Software verification, validation, and hazard analysis; Protocol for technical specification changes
  • False negative results leading to delay of further evaluation or treatment
    (Diagnostic algorithm failure, Software failure): Clinical performance testing
    Software verification, validation, and hazard analysis; Protocol for technical specification changes; Labeling
  • Operator failure to provide images that meet input quality specifications: Labeling,
    Training, Human factors validation testing

REGULATORY PATHWAY: De Novo request

  • Regulation No.: 21 CFR 886.1100
  • Regulation Name: Retinal diagnostic software device
  • Regulatory Class: Class II
  • Product Code: PIB

REIMBURSEMENT:

  • AI diagnostic approach could support CMS’ value-based reimbursement

ORDER


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Organ Care System (OCS) Lung System

TransMedics, Inc.

INDICATION FOR USE:  Portable organ perfusion, ventilation, and monitoring medical device indicated for the preservation of standard criteria donor lungs in a near physiologic, ventilated, and perfused state for double lung transplantation.

DESCRIPTION:

  • Lung Console: Non-sterile, reusable, portable enclosure housing electronic display and non-sterile mechanical/electrical elements to warm, pump, ventilate, and manage gas content of perfusate
  • Lung Perfusion Set (LPS): Sterile, single-use perfusion module, organ chamber and circulatory system to perfuse and ventilate lung,  facilitate management of fluids
  • OCS™ Lung Solution: High oncotic solution used for ex-vivo flush and perfusion of donor lungs when combined with packed red blood cells (pRBCs)

EFFECTIVENESS AND SAFETY:

  • Randomized, controlled, multi-center, international, prospective
    clinical trial, OCS™ Lung System vs. current cold storage standard of care (SOC), n=407
  • Primary Graft Dysfunction (PGD) grading,  including reduced survival and
    increased incidence of Bronchiolitis Obliterans Syndrome (BOS)
  • Patient survival at day 30 post-transplantation and ISHLT PGD3 within 72 hours post-transplantation
  • No-inferiority vs. SOC, longer-term (2-year) survival and BOS rates comparable
  • Similar lung graft-related serious adverse events (LGRSAEs) through 30 days post-transplantation

REGULATORY PATHWAY: PMA

  • Class III, Product Code: QBA
  • Priority Review
  • Gastroenterology-Urology Devices Panel Meeting: Voted 11-2 that there is reasonable assurance the device is safe, 8-5 that there is reasonable assurance that the device is effective, and 9-4 that the benefits of the device do outweigh the risks
  • Post-approval studies : Long-term patient outcomes, OCS Lung Thoracic Organ Perfusion (TOP) PAS Registry

LABEL 


Image credit: J&J, IDX, TransMedic

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