The U.S. Food and Drug Administration approved 32 innovative medical devices through its premarket approval process in 2019, a slight uptick from 31 in 2018.
The FDA 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 regulator.
In 2019, the U.S. FDA cleared Axonics Modulation Technologies Inc.'s rechargeable sacral neuromodulation implant for treating overactive bladders and urinary retention, Medtronic PLC's drug-coated balloon for treating failing arteriovenous access in certain kidney disease patients undergoing dialysis, and CVRx Inc.'s implant for patients with advanced heart failure.
Boston Scientific Corp. received premarket approvals in 2019 for its Vici venous stent system and Lotus Edge valve system. The company's Vici venous stent system was approved for treating iliofemoral venous obstructive disease, which occurs when blood flow in the pelvic region is blocked by a blood clot or from the veins being compressed by organs or arteries.
The Lotus Edge valve system is a minimally invasive transcatheter aortic valve replacement device approved for patients with aortic stenosis, a narrowing of the aortic valve that restricts blood flow.
The U.S. FDA also approved QIAGEN Manchester Ltd.'s therascreen PIK3CA RGQ PCR kit for use as a companion diagnostic test to detect the PIK3CA mutation in a tissue or a liquid biopsy in patients with breast cancer.
Meanwhile, the regulator signed off on 22 de novo applications in 2019, down from a record-setting 44 in 2018. 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.
Products cleared by the U.S. FDA under the de novo pathway in 2019 include PerkinElmer Inc.'s kit to screen for Duchenne muscular dystrophy in newborns, OPKO Health Inc.'s point-of-care test to detect prostate cancer, Hologic Inc.'s test for a sexually transmitted infection caused by the bacteria Mycoplasma genitalium, and OraSure Technologies Inc.'s test for the detection of Ebola virus antigens.
Tandem Diabetes Care Inc. also had two devices for the treatment of diabetes approved under the de novo process in 2019 — an automated insulin delivery system and an interoperable digital insulin pump.