Ethicon receives breakthrough device designation from the FDA

Ethicon, which is part of the Johnson & Johnson medical devices company, has been granted breakthrough device designation by the Food and Drug Administration (FDA) for its transbronchial microwave ablation technology using robotic-assisted bronchoscopy.

The technology is currently under development. 

Ethicon is a specialist in soft tissue microwave ablation and in flexible endoluminal robotics. The NEUWAVE microwave ablation system provides a minimally invasive option for soft tissue lesions, with more than 45,000 procedures performed to date, and the MONARCH platform provides improved reach into the periphery of the lung with continuous real-time vision, precision and control. MONARCH was reportedly the first robotic-assisted bronchoscopy system introduced in the United States with more than 3,300 procedures performed to date.

The breakthrough devices programme is a voluntary programme designed for certain medical devices that provide effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The programme goal is to provide patients and healthcare 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 authorisation, consistent with the agency's mission to protect and promote public health.

Vladimir Makatsaria, company group chairman of Ethicon, Johnson & Johnson, said: "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. We look forward to working collaboratively with the FDA to help prioritise development and access for patients."

Avrum Spira, global head of the lung cancer initiative at Johnson & Johnson, added: "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.

"This promising convergence of technologies offers an exciting opportunity to catalyse new approaches and solutions to improve patient outcomes, and we look forward to evaluating this device in a comprehensive clinical development programme."