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Ethicon Announces New Research to Advance Patient Care in Urology at Annual American Urological Association Meeting

Ethicon Announces New Research to Advance Patient Care in Urology at Annual American Urological Association Meeting

Redwood City, CA – May 12, 2022 – Auris Health, Inc., a subsidiary of Ethicon, Inc,a Johnson & Johnson MedTech company,* today announces four scientific abstract presentations to be delivered at the upcoming annual American Urological Association (AUA) meeting May 13-16, 2022 in New Orleans, LA. This is the first time endourology data will be presented on the MONARCH Platform, Urology a flexible robotic solution that enables urologists to reach and visualize areas within the kidney with precision and control.

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Ethicon’s MONARCH® Endoscopic Robotic Platform Receives FDA 510(k) Clearance for Urology Procedures

MONARCH is now the first and only multispecialty, flexible robotic solution for use in both bronchoscopy and urology.

Robotically assisted system is designed to elevate the standard of care for the surgical removal of kidney stones. *

REDWOOD CITY, CALIF. – May 2, 2022 – Auris Health, Inc., a subsidiary of Ethicon, Inc.,
a Johnson & Johnson MedTech company,** today announced that its MONARCH® Platform received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for endourological procedures. This clearance makes MONARCH the first and only multispecialty, flexible robotic solution for use in both bronchoscopy and urology. It is designed to enable urologists to reach and visualize areas within the kidney with precision and control.

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Mauna Kea Technologies Announces Start of Enrollment in Peripheral Lung Cancer Multi-Center Clinical Trial

Study will advance the validation of Cellvizio® as a real-time biopsy guidance tool during robotic-assisted bronchoscopy that may reduce the near-miss rate of peripheral lung cancer

PARIS AND BOSTON, February 22, 2022 – 5:45 PM CET – Mauna Kea Technologies (Euronext: MKEA) inventor of Cellvizio®, the multidisciplinary probe and needle-based confocal laser endomicroscopy (p/nCLE) platform, today announces that, as part of its collaboration with the Lung Cancer Initiative (“LCI”) at Johnson & Johnson 1, initial enrollment of patients has begun in a prospective, multi-center, open-label, single-arm clinical feasibility study sponsored by LCI. The study will combine nCLE and robotic-assisted bronchoscopy, using both Cellvizio and the Monarch® Platform from Auris Health, Inc., a subsidiary of Ethicon, Inc., part of the Johnson & Johnson Medical Devices Companies, to assess the capability of nCLE to accurately confirm needle position for the diagnosis of peripheral lung nodules (Clinicaltrials.gov: NCT05231278).

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First MONARCH® Robotic-Assisted Bronchoscopy Procedure Performed Outside the United States

Dr. Calvin S.H. Ng to Enroll Patients in TARGET Clinical Study at Prince of Wales Hospital, The Chinese University of Hong Kong, in Hong Kong, China

HONG KONG - December 7, 2021 - This week, the first MONARCH® Robotic-Assisted Bronchoscopy procedure was performed in Hong Kong, marking the first MONARCH procedure to take place outside of the United States.

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Mauna Kea Technologies Announces 5 Communications Highlighting The Clinical Value Of Cellvizio® In Interventional Pulmonology Presented During The European Respiratory Society (ERS) International Congress 2021

Mauna Kea Technologies (Euronext: MKEA) (Paris:MKEA) (OTCQX:MKEAY) inventor of Cellvizio®, the multidisciplinary probe and needle-based confocal laser endomicroscopy (p/nCLE) platform, today announces that 5 communications supporting Cellvizio® were presented during the recent European Respiratory Society (ERS) International Congress 2021. These presentations focused on the safety, efficacy, and feasibility of Cellvizio when used with manual and robotic-assisted bronchoscopy, fine-tuning sampling location and reduction of the bronchoscopic near-miss rate, and the application of Cellvizio in detecting fibrotic changes in vivo in patients diagnosed with COVID-19.

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Auris Health Announces Publication of Results from BENEFIT Study of MONARCH® Platform in CHEST

Data Demonstrates Safety of MONARCH Platform and Effective Localization of Peripheral Nodules

REDWOOD CITY, CALIF. – January 21, 2021 – Ethicon’s* Auris Health, Inc., part of Johnson & Johnson Medical Devices**, today announced results from the world’s first prospective, multicenter study of robotic bronchoscopy. The study, called BENEFIT, evaluated the safety and feasibility of the MONARCH® Platform, a first-of-its-kind robotic technology indicated for use in diagnostic and therapeutic bronchoscopic procedures. Results of the study were published in CHEST, the official publication of the American College of Chest Physicians.

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U.S. FDA Grants Ethicon Breakthrough Device Designation for Monarch-enabled NeuWave Microwave Ablation Technology

U.S. FDA Grants Ethicon Breakthrough Device Designation for Monarch-enabled NeuWave Microwave Ablation Technology

New Brunswick, N.J., July 30, 2020 – Ethicon, a Johnson & Johnson Medical Devices Company*, announced the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for transbronchial microwave ablation technology using robotic-assisted bronchoscopy, which is currently under development.

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Auris Health Announces Late-Breaking Results from First-in-Human Study of Monarch™ Platform

Data Presented at CHEST 2019 Demonstrates Efficacy of Monarch to Successfully Reach Nodules and Biopsy Tissue

NEW ORLEANS – October 23, 2019 – Auris Health, Inc. (“Auris Health”), part of Johnson & Johnson Medical Devices Companies,* today announced results from a study demonstrating the safety and feasibility of the Monarch Platform, a first-of-its-kind robotic technology indicated for use in diagnostic and therapeutic bronchoscopic procedures. Data from the BENEFIT study was presented in a late-breaking session at the CHEST 2019 Conference in New Orleans by Alexander C. Chen, M.D., of St. Louis, Mo.

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Auris Health Celebrates 1,000 Cases with the MONARCH® Platform

REDWOOD CITY – August 22, 2019 – Auris Health, Inc., part of Johnson & Johnson Medical Devices Companies, today announced that physicians have performed over 1,000 bronchoscopic procedures using the Monarch™ Platform. Auris gained FDA clearance for diagnostic and therapeutic bronchoscopic procedures on the Monarch Platform in the Spring of 2018.

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Independent Feasibility Study Demonstrates High Navigation Success with Auris Health’s MONARCH® Platform for Robotic-Assisted Bronchoscopy

Researchers conclude the Monarch™ Platform overcomes some limitations of conventional bronchoscopic systems in diagnosing lung nodules

Redwood City, Calif. and Dallas – May 21, 2019 – Auris Health, Inc., part of Johnson & Johnson Medical Devices Companies,* today announced that interim results from an independent pilot feasibility study designed to evaluate the company’s Monarch Platform were presented at the American Thoracic Society (ATS) 2019 Conference in Dallas. The Monarch Platform is a first-of-its-kind robotic technology cleared by the U.S. Food and Drug Administration (FDA) for diagnostic and therapeutic bronchoscopic procedures.

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