The U.S. Food and Drug Administration approved 40 innovative medical devices through its premarket approval process in 2020, a 25% increase from 32 a year earlier.
The regulator uses the premarket approval, or PMA, pathway to evaluate the safety and effectiveness of class III medical devices, which support or sustain human life, but could also potentially bring a risk of illness or injury. PMA is the most stringent type of device marketing application required by the agency.
During the year, Roche Holding AG received premarket approvals for its cobas HIV-1/HIV-2 qualitative test, for confirming HIV diagnosis and differentiating between types of the infection; its human papillomavirus, or HPV, test, for use on the cobas 6800/8800 systems to detect cervical cancer; its CINtec PLUS Cytology, for identifying women with HPV at risk of precancers of the cervix; its Elecsys HIV duo; and its cobas EZH2 mutation test.
The Swiss drugmaker's unit Foundation Medicine Inc. likewise received premarket approval for FoundationOne Liquid CDx, a liquid biopsy test for all solid tumors with multiple companion diagnostic indications. A liquid biopsy is a plasma-based test that is less invasive than a tissue biopsy for assessing germline or somatic BRCA mutations.
The U.S. regulator also cleared Koninklijke Philips NV's HeartStart FR3 and HeartStart FRx automated external defibrillators, which are used to treat cardiac arrest. The HeartStart FR3 is a professional-grade system to help medical personnel and first-responders treat cardiac arrest, while the HeartStart FRx is a public-access system that features step-by-step voice instructions, including guidance for cardiopulmonary resuscitation for emergencies.
Also among those approved in 2020 were Guardant Health Inc.'s blood test Guardant360 CDx, for detecting various cancers, and Chembio Diagnostics Inc.'s DPP HIV-Syphilis system, for diagnosing HIV and syphilis.
Meanwhile, the U.S. FDA signed off on 26 de novo applications in 2020, an uptick from 22 de novo clearances in 2019. De Novo classification is a risk-based regulatory process reserved for class I or class II medical devices that have a moderate risk compared to class III devices, and do not require as much scrutiny.
Devices cleared by the regulator under the de novo pathway in 2020 include Medtronic PLC's Carpediem system, the first blood filtration device for children with certain kidney conditions; Bay Labs Inc.'s Caption Guidance imaging software, the first artificial intelligence-assisted heart imaging software; and Roche's cobas test, which monitors Epstein-Barr virus levels.
Miach Orthopaedics Inc.'s knee-ligament implant, Acarix AB (publ)'s heart diagnostic device, Asuragen Inc.'s test kit for Fragile X Syndrome, and Interscope Inc.'s device for removing dead pancreatic tissue, also received clearances under the de novo process.