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May 12 2022
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.
Continue ReadingMay 01 2022
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.
Continue ReadingFeb 22 2022
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).
Continue ReadingDec 07 2021
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.
Continue ReadingOct 04 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.
Continue ReadingJan 21 2021
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.
Continue ReadingJul 30 2020
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.
Continue ReadingOct 23 2019
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.
Continue ReadingAug 26 2019
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.
Continue ReadingMay 21 2019
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.
Continue ReadingBronchoscopy:
Complications from bronchoscopy are rare and most often minor, but if they occur, may include breathing difficulty, vocal cord spasm, hoarseness, slight fever, vomiting, dizziness, bronchial spasm, infection, low blood oxygen, bleeding from biopsied site, or an allergic reaction to medications. Only rarely do patients experience other more serious complications (for example, collapsed lung, respiratory failure, heart attack and/or cardiac arrhythmia).
Urology:
Adverse effects from both Mini-PCNL and Ureteroscopy include pain, urinary tract infection, fever, hematuria (presence of blood in urine), exposure to low levels of radiation, retained or residual stones.
Adverse effects from ureteroscopy may include pain, perforation or injury to the ureter, resulting in extravasation of fluid and urine (urinoma), stricture of the ureter with risk of subsequent obstruction (hydronephrosis needing further repair), rare avulsion of the ureter, urinary blood clots, residual stones.
PCNL access may result in minor and major adverse effects. Minor effects include fever and nephrostomy leak. Major adverse effects may include injuries to pleura, liver, spleen, large vessels with related bleeding, gallbladder, duodenum, jejunum, colon with related cutaneous fistula, fever, pain, ileus, elevated counts.
Major adverse effects related to stone removal may include infection and urosepsis, intravascular fluid overload, extravasation of fluid, and post percutaneous nephrolithotomy bleeding.