The goal of the Breakthrough Devices Program is to provide patients and health care providers with timely access to these medical devices by speeding up their development, assessment, and review, while preserving the statutory standards for premarket approval, 510(k) clearance, and De Novo marketing authorization, consistent with the Agency's mission to protect and promote public health.
"Our acquisitions of NeuWave Medical and Auris Health have enabled us to bring two best-in-class platforms together as we work to develop this breakthrough technology," said Vladimir Makatsaria, company group chairman of Ethicon, Johnson & Johnson. "We look forward to working collaboratively with the FDA to help prioritize development and access for patients."
The NeuWave Microwave Ablation System provides a minimally invasive option for soft tissue lesions, with more than 45,000 procedures performed to date. The Monarch Platform provides improved reach into the periphery of the lung with continuous real-time vision, precision and control. Monarch was the first robotic-assisted bronchoscopy system introduced in the United States with more than 3,300 procedures performed to date.
“Through our commitment to transform patients' lives, Johnson & Johnson is advancing innovative solutions with a focus on the prevention, interception and cure of some of the world's most complex, life-threatening diseases," said Avrum Spira, M.D., M.Sc., global head of the Lung Cancer Initiative at Johnson & Johnson. "This promising convergence of technologies offers an exciting opportunity to catalyze new approaches and solutions to improve patient outcomes, and we look forward to evaluating this device in a comprehensive clinical development program.”