Temple University Hospital performs nation's 1st post-FDA approval BLVR using Zephyr Valve
(Temple University Health System) Temple University Hospital has become the first US center to perform bronchoscopic lung volume reduction using implantation of the Zephyr ® Endobronchial Valve (Zephyr ® EBV ® ) to treat severe emphysema following US FDA approval. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - August 20, 2018 Category: International Medicine & Public Health Source Type: news
Breathing Easier with Single-Use Bronchoscopes
This study was specifically done for bronchoscopes because that data was lacking,” says Lars Marcher, CEO and President Ambu A/S, in an interview with MD+DI.
Contamination of reusable endoscopes has been known for some time now. “Endoscope Reprocessing Failures Continue to Expose Patients to Infection Risk” was number two on ECRI Institute’s list of Top 10 health technology hazards for 2018. And it has been on the organization’s top 10 list for the past eight years.
Shifting to single-use instruments will likely be cost effective as well. According to a 2017 study, “Early Assessment of the Likely Cost Effectiv...
Source: MDDI - July 12, 2018 Category: Medical Devices Authors: Susan Shepard Tags: Sterilization Source Type: news
How a New Emphysema Device Won FDA Approval in Six Months
FDA has approved a new device intended to treat breathing difficulty associated with severe emphysema. The approval comes just two weeks after an FDA advisory panel shot down a competing technology targeting the same patient population.
The agency approved Pulmonx Inc.'s Zephyr endobronchial valve through the breakthrough device designation, a pathway reserved for devices that provide for more effective treatment or diagnosis of a life-threatening or irreversibly debilitating disease or condition. Devices also must meet one of the following criteria: the device must represent a breakthrough technology; there must be no app...
Source: MDDI - July 2, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Regulatory and Compliance Source Type: news
Pulmonx wins FDA approval for Zephyr endobronchial valve
The FDA today granted pre-market approval under its breakthrough devices designation to the Zephyr endobronchial valve made by Pulmonx for treating severe emphysema.
Emphysema, a chronic obstructive pulmonary disease, causes irreversible damage to the lung’s alveoli, trapping air during exhalation that in turn can cause the diseased tissue to grow larger and pressure healthy lung tissue. The Zephyr device is designed to decrease the volume of the chest to improve function in the heart, respiratory muscles and healthy lung tissue. Inserted via bronchoscopy, the pencil-eraser-sized valves prevent air from entering th...
Source: Mass Device - June 29, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Endoscopic / Arthroscopic Food & Drug Administration (FDA) Regulatory/Compliance Respiratory Pulmonx Source Type: news
Bronchoscopes still dirty after cleaning, study says
Photo by Michaela33 courtesy of Flikr
A new study has found that currently acceptable methods of reprocessing reusable bronchoscopes left most devices contaminated and damaged.
“The results are worrisome as patients undergoing bronchoscopy are commonly at high risk for infection due to transplant status, critical illness, or immune-suppression due to malignancy or chronic disease,” said the study, funded by 3M and supported by sterilization product maker Healthmark Industries. It was presented last week at the Association for Professionals in Infection Control’s annual conference APIC 2018, will be publi...
Source: Mass Device - June 19, 2018 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Diagnostics Endoscopic / Arthroscopic Regulatory/Compliance Sterilization / Calibration 3m Healthmark superbugs Source Type: news
Medical News Today: What to expect from a bronchoscopy
A bronchoscopy is a safe, relatively quick procedure. It allows a doctor to examine the inside of the lungs, which can help them to diagnose the cause of breathing problems or chest pain. In this article, learn what to expect before, during, and after a bronchoscopy, including recovery and possible complications. (Source: Health News from Medical News Today)
Source: Health News from Medical News Today - June 18, 2018 Category: Consumer Health News Tags: Respiratory Source Type: news
FDA panel votes against BTG ’ s PneumRX Elevair
An FDA advisory committee panel yesterday voted against approving BTG‘s PneumRX’s Elevair endobronchial coil system intended for treating patients with severe emphysema.
The panel voted 7 to 5 in favor of the device’s safety, but 8 to 3 that the benefits do not outweigh the risks, and 5 to 7 that the device was effective for use with patients in its proposed indications.
The Elevair device is a nitinol endobronchial coil intended to be deployed bronchoscopically to reduce lung volume in patients with severe emphysema. The company submitted an application for premarket approval with the FDA, backed by clinical...
Source: Mass Device - June 15, 2018 Category: Medical Devices Authors: Fink Densford Tags: Food & Drug Administration (FDA) Respiratory BTG Source Type: news
Intuitive Surgical drops $15m, inks collab dev and licensing deal in Broncus Medical Series A
Broncus Medical said today it raised $15 million in a Series A from robotic surgery giant Intuitive Surgical (NSDQ:ISRG).
The investment comes in three parts, including the $15 million equity investment, a technology development collaborative agreement and a licensing deal that will put Broncus Medical’s intellectual properties in Sunnyvale, Calif.-based Intuitive’s hands.
Broncus Medical is developing technologies focused on diagnostic and therapeutic lung procedures, and will use funds from the round to support continued development of its lung cancer tech, including clinical trials. The company is currently...
Source: Mass Device - June 12, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Imaging Respiratory Broncus Medical Intuitive Surgical Source Type: news
Auris Health named to CNBC Disruptor 50 list
Auris Health, previously known as Auris Surgical Robotics, has been named to to CNBC’s Disruptor 50 list, and is the only medical device company to be included.
The Redwood City, Calif.-based company was selected due to its focus on lung cancer, which CNBC said kills more individuals in the US than any other type of cancer, and its founder, robotic surgical pioneer and intuitive surgical founder Dr. Frederic Moll.
The company has already raised $513 million in equity capital from major tech investors and recently won FDA approval for its robotic Monarch Platform.
Topping the list are Elon Musk’s SpaceX, ridesharing se...
Source: Mass Device - May 22, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Robotics aurishealth Source Type: news
Auris Health, Ethicon ’ s NeuWave ink robot-assisted bronchoscope ablation dev deal
Auris Health, previously known as Auris Surgical Robotics, said today it inked a cooperative development and commercialization deal with Johnson & Johnson (NYSE:JNJ) division Ethicon’s NeuWave Medical subsidiary looking to develop systems for the robotically-assisted bronchoscopic ablation of lung lesions.
Through the agreement, both companies will help develop an integrated system for robotic control, navigation and application of bronchoscope-delivered microwave ablation. The bronchoscope in development will be equipped with a small camera and accessory channel to allow tools to enter the lungs through the mou...
Source: Mass Device - May 16, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Endoscopic / Arthroscopic Respiratory Robotics aurishealth Ethicon johnsonandjohnson NeuWave Medical Inc. Source Type: news
Body Vision Medical wins FDA nod for LungVision lung nav cath
Body Vision Medical said today it won FDA clearance for its LungVision lung navigation catheter.
The Israel-based company said its LungVision catheter is designed for use in conjunction with standard bronchoscopes and its LungVision system for guiding endotherapy accessories to small pulmonary modules.
“Body Vision has pioneered a new generation platform for navigation bronchoscopy that applies augmented reality approach to plan, visualize, and accurately track radiolucent bronchial nodules in real time. LungVision navigation tool has clear performance and cost benefits over current navigation tools that are bound to...
Source: Mass Device - April 30, 2018 Category: Medical Devices Authors: Fink Densford Tags: Food & Drug Administration (FDA) Imaging Regulatory/Compliance Respiratory Body Vision Medical Source Type: news
Early Release: Evaluation of Bronchoalveolar Lavage Fluid from Patients in an Outbreak of E-cigarette, or Vaping, Product Use-Associated Lung Injury - 10 States, August-October 2019
Bronchoscopy and bronchoalveolar lavage can be part of the clinical and diagnostic workup of e-cigarette, or vaping, product use-associated lung injury patients. (Source: CDC Morbidity and Mortality Weekly Report)
Source: CDC Morbidity and Mortality Weekly Report - April 17, 2018 Category: American Health Tags: Electronic Cigarettes (e-cigarette) Lung Health MMWR Morbidity & Mortality Weekly Report Outbreaks Flavorings-Related Lung Disease Source Type: news
UPDATE: Moll ’ s Auris wins FDA nod for Monarch robotic endoscopy platform
Updated to include commentary from Auris chief strategy officer Josh DeFonzo.
Auris Health, previously known as Auris Surgical Robotics and formed by Intuitive Surgical (NSDQ:ISRG) founder Dr. Frederic Moll, said today it won FDA clearance for its Monarch robotic endoscopy platform.
The Redwood City, Calif.-based company said it’s Monarch robotic platform’s initial aim will be on treating lung cancer, with the FDA clearance indicating the device for use in diagnostic and therapeutic bronchoscopic procedures.
Auris touted that the system enables more accurate diagnosis and treatment of small and hard-to-reach n...
Source: Mass Device - March 23, 2018 Category: Medical Devices Authors: Fink Densford Tags: Endoscopic / Arthroscopic Food & Drug Administration (FDA) Regulatory/Compliance Respiratory Robotics aurishealth Source Type: news
Moll ’ s Auris wins FDA nod for Monarch robotic endoscopy platform
Auris Health, previously known as Auris Surgical Robotics and formed by Intuitive Surgical (NSDQ:ISRG) founder Dr. Frederic Moll, said today it won FDA clearance for its Monarch robotic endoscopy platform.
The Redwood City, Calif.-based company said it’s Monarch robotic platform’s initial aim will be on treating lung cancer, with the FDA clearance indicating the device for use in diagnostic and therapeutic bronchoscopic procedures.
Auris touted that the system enables more accurate diagnosis and treatment of small and hard-to-reach nodules in the periphery of the lung.
“Technology has advanced significan...
Source: Mass Device - March 23, 2018 Category: Medical Devices Authors: Fink Densford Tags: Endoscopic / Arthroscopic Food & Drug Administration (FDA) Regulatory/Compliance Respiratory Robotics aurishealth Source Type: news
This Liquid Biopsy Can Rule Out Early-Stage Lung Cancer
A new study has confirmed the accuracy of a liquid biopsy that can help rule out early-stage lung cancer.
Published in the journal CHEST, the PANOPTIC clinical trial validated the Xpresys Lung 2 (XL2) test developed by Seattle-based Integrated Diagnostics. The test can detect two blood plasma proteins that are indicative of cancer in otherwise difficult-to-biopsy lung nodules measuring 8 to 30 mm.
About 1.6 million pulmonary nodules are detected each year in the United States, and more than 90% of those smaller than two centimeters (around 3/4 inch) in diameter are benign, according to the Cleveland Clinic. Current detecti...
Source: MDDI - March 17, 2018 Category: Medical Devices Authors: Nancy Crotti Tags: IVD Source Type: news
