FDA breakthrough device designations set for another banner year


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The Food and Drug Administration is poised to deliver another banner year for breakthrough medical device designations. In the middle of the year, the agency had granted 129 designations, putting him on track to break the previous annual record of 206.

The number of designations has increased each year of the program. In 2015, 11 were issued under the fast-track pathway, the precursor to the breakthrough program, while in 2019 the program surpassed 100 breakthrough designations for the first time. By 2021, the annual number of breakthrough medical device designations had risen to more than 200 for the first time.

Earlier this year, the FDA provided a harbinger that it could set a new record in 2022. In late March, the agency had granted 64 breakthrough device designations. If sustained throughout the year, the pace of designations seen in the first quarter would lead the FDA to grant a record 256 breakthrough designations in 2022.

In the second quarter, the agency granted another 65 breakthrough device designations to bring the 2022 total to 129 at the end of June. The FDA has already granted more breakthrough device designations in 2022 than it did in 2019 and, given that the latest data is almost six weeks old, it may also have exceeded the 151 approvals that it received. she awarded in 2020.

Neurological devices accounted for 12 of the breakthrough statuses awarded in the second quarter, making it the most active clinical area for new designations during the period. The total number of neurological device designations awarded by the FDA increased from 114 to 126, cementing the clinical area’s status as the program’s second most active area. Cardiovascular disease remains the most active area, while neurology closes the gap, its total rising from 158 to 163.

The FDA granted six breakthrough device designations in orthopedics, the third most active area of ​​the program, bringing the total to 77. The total number of designations across all clinical areas stood at 693 at the end of June .

The number of breakthrough devices cleared by the FDA also increased in the second quarter, from 44 to 54 between the end of March and the end of June. The 10 authorizations represent a record for a single quarter. The agency cleared 15 breakthrough devices in the past year, though with just one clearing in Q1 2022 still falling short of the full year 2021 total.

Q2 Selected Permissions of Breakthrough Devices

Transmedics: The FDA obtained premarket approval to TransMedics’ OCS Cardiac System for use with donor organs after a circulatory death in April. The authorization covers ex vivo resuscitation, functional monitoring and beating-heart preservation of donated hearts after circulatory death. TransMedics authorization previously received use the system to preserve donated hearts after brain death.

EarliTec Diagnosis: The 510(k) Authorization EarliTec Diagnostics’ EarliPoint Assessment for Autism Spectrum Disorders has expanded the tools available to determine if children ages 16-30 months have ASD. The technology is designed to measure a child’s preferential attention to critical social information and, in doing so, provide the first objective measure to inform diagnosis.

Fujirebio Diagnosis: The FDA granted De novo marketing authorization for Fujirebio Diagnostics’ Lumipulse G β-Amyloid Ratio in vitro diagnostic test in May. Using the test, physicians can assess beta-amyloid pathology in patients being evaluated for Alzheimer’s disease and other causes of cognitive decline. The test is the first FDA cleared to support the assessment of Alzheimer’s disease.

Renovia: The agency erased First-line treatment of Renovia for chronic faecal incontinence on the last day of the second trimester. The Leva Pelvic Health System, which the FDA previously cleared to treat mild-to-moderate, mixed, stress urinary incontinence in women, is a prescription digital therapy that guides women through training the muscles of the pelvic floor.


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