Is J & amp;J Becoming a Surgical Robotics Powerhouse?
Johnson & Johnson is making some significant noise in the surgical robotics space today as it is announcing a deal that would have it acquire Auris Health for $3.4 billion. The deal also calls for additional contingent payments of up to $2.35 billion in the event of Auris reaching certain milestones. J&J would make the acquisition through its Ethicon subsidiary. Redwood City, CA-based Auris Health develops robotic technologies that have been focused on lung cancer. The firm has the Monarch Platform, an FDA cleared system currently used in bronchoscopic diagnostic and therapeutic procedures. In November of 2018, Aur...
Source: MDDI - February 13, 2019 Category: Medical Devices Authors: Omar Ford Tags: Business Digital Health Source Type: news

PETA: Cincinnati Children ’s agrees to halt use of live cats to train doctors
Cincinnati Children ’s Hospital executives ordered that live cats no longer be used to teach human bronchoscopy and intubation techniques to doctors from around the world, apparently following a complaint from People for the Ethical Treatment of Animals. Physicians who teach a pediatric flexible bronchoscopy post-gr aduate course will no longer use animals, according to a Feb. 8 letter sent to PETA by Dr. Margaret Hostetter, chair of the Department of Pediatrics at Cincinnati’s largest hospital. Hostetter… (Source: bizjournals.com Health Care:Physician Practices headlines)
Source: bizjournals.com Health Care:Physician Practices headlines - February 13, 2019 Category: American Health Authors: Barrett J. Brunsman Source Type: news

Johnson & Johnson delves into robotics, buys Auris Health for $3.4 billion
Johnson& Johnson, one of the largest maker of health products, is now in the robotics space. The New Brunswick, New Jersey-based company announced Wednesday that it would buy surgery firm Auris Health for $3.4 billion in cash. Auris Health is a privately held developer of robotic technologies, initially focused in lung cancer, with an FDA-cleared platform currently used in bronchoscopic diagnostic and therapeutic procedures. This latest deal is expected to bolster Johnson& Johnson ’s entry… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - February 13, 2019 Category: Biotechnology Source Type: news

Johnson and Johnson Announces Agreement to Acquire Auris Health, Inc.
Auris Health's Robotic Platform Expands Johnson & Johnson's Digital Surgery Portfolio NEW BRUNSWICK, N.J., Feb. 13, 2019 -- (Healthcare Sales & Marketing Network) -- Focused on creating the next frontier of surgery, Johnson & Johnson (NYSE: JNJ), today... Devices, Mergers & Acquisitions Johnson & Johnson, Auris Health, bronchoscopy, robotic (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - February 13, 2019 Category: Pharmaceuticals Source Type: news

J & J to enter the robotic surgery market with $3.4B Auris Health buy
Johnson & Johnson (NYSE:JNJ) is stepping into the field of robotic surgery after saying today that its Ethicon subsidiary inked a $3.4 billion deal to pick up surgical robotics pioneer Dr. Fred Moll’s newest robotic surgical play, Auris Health, and its FDA-cleared Monarch platform. The New Brunswick, N.J.-based medtech giant said that the deal will include an additional $2.35 billion in milestone-based contingent payments, bringing the total value of the deal to approximately $5.75 billion. Redwood City, Calif.-based Auris Health’s robotic Monarch platform has FDA clearance for diagnostic and ther...
Source: Mass Device - February 13, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Featured Mergers & Acquisitions Robotics Wall Street Beat aurishealth johnsonandjohnson Source Type: news

New assay selects patients with lung cancer for treatment with immune checkpoint inhibitors
(Elsevier) A report in The Journal of Molecular Diagnostics describes a novel and rapid approach for quantifying PD-L1 expression levels in tumors that requires only small amounts of tissue that can be collected using minimally invasive bronchoscopy techniques. This approach can also be used to discriminate malignant from benign tumors and identify mutational status, all of which can guide and refine therapeutic decisions. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - February 13, 2019 Category: International Medicine & Public Health Source Type: news

Why Was This Nonsmoker Coughing for Months?
(MedPage Today) -- COPD inhaler didn't help, but bronchoscopy did (Source: MedPage Today Pulmonary)
Source: MedPage Today Pulmonary - February 4, 2019 Category: Respiratory Medicine Source Type: news

Real-World Data on Medtronic & #039;s Lung Cancer Device Is Promising
Recently published results of a large, multicenter trial could go a long way toward boosting adoption of electromagnetic navigation bronchoscopy (ENB) procedures using Medtronic's superDimension navigation system to aid in lung cancer diagnosis, staging, and treatment. The 12-month results of the NAVIGATE study were published in the Journal of Thoracic Oncology. "It's not enough anymore to just make a really amazing new technology, it has to be backed with clinical and economic evidence and one that allows really broad adoption around the globe to really impact as many patients as we can," Emily Elswi...
Source: MDDI - January 31, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news

Medtronic touts U.S. results of lung cancer detection trial
Partial results of a huge, real-world study of Medtronic’s (NYSE:MDT) superDimension LungGPS technology found that 65% of patients diagnosed with primary lung cancer (Stages I and II) were at early stages of the disease. Early detection of lung cancer is critical to improving patient outcomes long-term. The results came from a 12-month follow-up of the 1,215-patient U.S. portion of the Navigate trial. Begun in 2015, the trial was designed to evaluate the performance of the LungGPS electromagnetic navigation bronchoscopy (ENB) technology that the superDimension device uses to navigate the lungs. Results...
Source: Mass Device - January 30, 2019 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Clinical Trials Featured Oncology Covidien journalofthoraciconcology Medtronic Source Type: news

J & J may nab surgical robotics company Auris Health
Johnson & Johnson (NYSE:JNJ) intends to acquire surgical robotics company Auris Health, according to a report by Bloomberg News. In May 2018, Auris inked an agreement with J&J’s division Ethicon’s NeuWave Medical subsidiary to develop systems for the robotically-assisted bronchoscopic ablation of lung lesions. J&J has been working with Alphabet‘s (NSDQ:GOOGL) Verily Life Sciences on Verb Surgical’s prototype robot-assisted surgery platform. J&J wants to spend more for Auris than the smaller company’s $2 billion valuation from its latest funding round, t...
Source: Mass Device - January 23, 2019 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Business/Financial News Endoscopic / Arthroscopic Mergers & Acquisitions Robotics aurishealth johnsonandjohnson Source Type: news

Olympus announces Spiration bronchial valve launch
The Spiration valve is an umbrella-shaped device that a health provider places in a targeted airway of the lung during a short bronchoscopic procedure. [Image courtesy of Olympus]Olympus’  Spiration bronchial valve for the treatment of severe emphysema is now available on the market, the company  (TYO:7733) said today. The announcement came a little over a year after FDA approval of Spiration, which was designated as a breakthrough medical device. Spiration also has regulatory approval in the E.U., Australia and New Zealand. Get the full story on our sister site Medical Design & Outsourci...
Source: Mass Device - January 22, 2019 Category: Medical Devices Authors: Chris Newmarker Tags: Business/Financial News News Well emphysema Olympus Source Type: news

Penn Highlands Healthcare first in the region to offer first FDA-approved lung valve for patients with severe COPD/emphysema
(Pulmonx) Penn Highlands Healthcare is the first medical facility in the region to offer bronchoscopic lung volume reduction using the first lung valve approved by the US Food and Drug Administration for helping emphysema patients breathe easier without major surgery. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - January 8, 2019 Category: International Medicine & Public Health Source Type: news

Foreign body aspiration of the lower airways in children - diagnosis in clinical practice - Hajnal D, Kov ács T.
INTRODUCTION AND AIM: Rigid bronchoscopic foreign body removal is the gold standard procedure for foreign body aspiration. We have analysed our results of bronchoscopies and the accuracy of diagnosis among the paediatric population in Southeast Hungary. ... (Source: SafetyLit)
Source: SafetyLit - December 19, 2018 Category: International Medicine & Public Health Tags: Age: Infants and Children Source Type: news

National Institute for Health and Care Excellence (NICE) issues new guidelines for COPD
(Pulmonx) NICE makes a 'strong' recommendation that patients with severe COPD be referred for evaluation for bronchoscopic lung volume reduction, including the Zephyr ® Endobronchial Valve System.NICE has broadened the criteria for evaluation and a new group of people for whom lung volume reduction surgery was unsuitable may now be evaluated for treatment with Zephyr Valves, a less invasive treatment option. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - December 11, 2018 Category: International Medicine & Public Health Source Type: news

Olympus wins FDA nod for Spiration bronchial valve
Olympus (TYO:7733) said yesterday that it won FDA approval for its Spiration Valve System intended to treat severe emphysema, which was designated as a breakthrough medical device. The Spiration Valve is an umbrella shaped device intended to improve breathing by blocking airflow to diseased portions of the lung, the Tokyo-based company said. The device is placed during a bronchoscopic procedure to reduce lung volume in diseased lung sections and allow healthier tissue in the remaining portion of the lung to function better. Approval of the device came based on the results from the Emprove clinical trial of the SV...
Source: Mass Device - December 6, 2018 Category: Medical Devices Authors: Fink Densford Tags: Food & Drug Administration (FDA) Regulatory/Compliance Respiratory Olympus Source Type: news

Auris Scores Big with $200M Raise for Robotics Platform
The robotics market is surging. Auris Health recent raise of $200 million to commercialize the Monarch Platform is a perfect example. The Redwood City, CA-based company has raised more than $700 million to develop and commercialize the Monarch platform - a robotic system that enables more-accurate diagnosis and treatment of small and hard-to-reach nodules in the periphery of the lung. Monarch received FDA clearance for Monarch to perform diagnostic and therapeutic bronchoscopic procedures earlier this year. The platform uses a familiar controller interface to navigate a flexible robotic endoscope to the periphery of the lu...
Source: MDDI - November 30, 2018 Category: Medical Devices Authors: Omar Ford Tags: Business Source Type: news

Auris Health closes $220m equity funding round
Auris Health said today that it closed a $220 million equity financing round to help support its next-generation Monarch robotic interventional platform. The Redwood City, Calif.-based company said that the round was led by Partner Fund Management and joined by newly invested Wellington Management, D1 Capital Partners and Senator Investment Group and existing investors Mithril Capital, Lux Capital and Viking Global Investors. The funding round brings the total raised for its Monarch surgical platform up to $700 million, Auris Health said. “The support of this group of world-class investors will be instrumental as Aur...
Source: Mass Device - November 28, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Featured Robotics Wall Street Beat aurishealth Source Type: news

Pulmonx wins Aetna coverage for Zephyr endobronchial valve
Pulmonx said yesterday that it won national coverage through health insurer Aetna for its Zephyr endobronchial valve system intended for treating severe emphysema and chronic obstructive pulmonary disorder. The coverage will make the Zephyr valve available to Aetna’s 22 million members, the Redwood City, Calif.-based company said. Under its new policy, Aetna specifically named the Zephyr as an approved bronchoscopic option for lung volume reduction, considering it medically necessary for the broncoscopic treatment of adult patients with hyperinflation associated with severe emphysema in regions of the lung with littl...
Source: Mass Device - November 15, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Respiratory Pulmonx Source Type: news

Bronchoscopy
(Source: eMedicineHealth.com)
Source: eMedicineHealth.com - October 22, 2018 Category: General Medicine Source Type: news

Auris Health touts robotically-assisted bronchoscopy study results
Auris Health’s Monarch bronchoscopy platform reached lung nodules and biopsied tissue with “high accuracy” in a recent study, according to the company. Eight investigators performed robotic-assisted bronchoscopy procedures using the Monarch platform on a cadaveric model designed to mimic a real-life bronchoscopy procedure. Sixty-seven simulated tumor targets one to three centimeters in size were prepared in eight human cadaveric lungs. The tissue acquired during the bronchoscopy was evaluated and correctly identified as the implanted target in 97% of cases, the study noted. Auris presented the results of ...
Source: Mass Device - October 15, 2018 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Featured Oncology Robotics aurishealth johnsonandjohnson Source Type: news

Finding Lung Cancer Outside the Airways Just Got Easier
Diagnosing solitary lung tumors located outside of a patient's main airways has long been a challenge, but evidence is building around a technology designed to improve access to such tumors. According to data unveiled this week at the European Respiratory Society International Congress in Paris, Broncus Medical's Archimedes virtual bronchoscopy navigation system helped to more than double the diagnostic yield for nodules with negative bronchus sign or an airway leading to the nodule. The six-year-old, San Jose, CA-based company said the Archimedes System is the only system of its kind offering real-...
Source: MDDI - September 17, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Imaging Source Type: news

New Bronchoscopic Option Used for Severe Emphysema
First bronchoscopic lung volume reduction using endobronchial valve performed at Temple University (Source: Pulmonary Medicine News - Doctors Lounge)
Source: Pulmonary Medicine News - Doctors Lounge - September 10, 2018 Category: Respiratory Medicine Tags: Pulmonology, Surgery, Institutional, Source Type: news

New Bronchoscopic Option Used for Severe Emphysema
MONDAY, Sept. 10, 2018 -- Temple University Hospital has become the first center in the U.S. to perform bronchoscopic lung volume reduction using implantation of the Zephyr Endobronchial Valve (Zephyr EBV) to treat hyperinflation associated with... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - September 10, 2018 Category: Pharmaceuticals Source Type: news

Body Vision raises $8.5 million to market cancer diagnostic system in U.S.
Body Vision Medical said today it has landed $8.5 million in funding to accelerate the commercialization of its LungVision lung navigation system in the U.S. and to extend its product line. The Ramat Ha Sharon, Israel-based company specializes in lung cancer diagnostics through augmented real-time intra-body navigation and imaging. Its catheter is designed for use in conjunction with standard bronchoscopes and its LungVision system for guiding endotherapy accessories to small pulmonary nodules.  LungVision’s catheter won FDA clearance in April. Its imaging and navigation system was cleared in May 2017. &ldq...
Source: Mass Device - September 5, 2018 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Business/Financial News Catheters Diagnostics Oncology Body Vision Medical Source Type: news

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...
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 ent...
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 p...
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 clin...
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 curre...
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, ri...
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...
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

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-rea...
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 signif...
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

Reimbursement Trends for Medical Devices in Japan
In conclusion, with the regulatory review speed by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) becoming competitive with FDA for PMA devices and the time to reimbursement being about a year after regulatory clearance with 80% of U.S. list price, Japan might be the best market, after the United States, to enter as an international market for many new companies. For 510(k) devices, the speed of reimbursement will be the same, although the speed to regulatory clearance remains a challenge. How soon a U.S. manufacturer submits the regulatory submission to PMDA is still the most substantial gap in term of co...
Source: MDDI - March 6, 2018 Category: Medical Devices Authors: Keisuke Suzuki Tags: Regulatory and Compliance Source Type: news

How Do Deep Neck Infections Present?
Discussion Deep neck space infections (DNSI) are not very common (estimated to be 4.6/100,000) but extremely important to have a high index of suspicion for. The anatomy of DNSs is complex and covered by substantial amounts of superficial soft tissue making diagnosis difficult. Additionally, children often cannot give more precise or accurate histories and can be difficult to examine> Most infections in children are in those
Source: PediatricEducation.org - February 26, 2018 Category: Pediatrics Authors: pediatriceducationmin Tags: Uncategorized Source Type: news

The use of a simple three-level bronchoscopic assessment of inhalation injury to predict in-hospital mortality and duration of mechanical ventilation in patients with burns - Aung MT, Garner D, Pacquola M, Rosenblum S, McClure J, Cleland H, Pilcher DV.
Major burn centres in Australia use bronchoscopy to assess severity of inhalation injuries despite limited evidence as to how best to classify severity of inhalational injury or its relationship to patient outcomes. All patients with burns who were admitte... (Source: SafetyLit)
Source: SafetyLit - January 25, 2018 Category: International Medicine & Public Health Tags: Burns, Electricity, Explosions, Fire, Scalds Source Type: news

Olympus PeriView FLEX TBNA Needle Brings New Capabilities to Early Diagnosis of Lung Disease
The First TBNA Needle Designed for Peripheral Bronchoscopy Featuring Increased Flexibility and Smaller Outer Diameter, Brings the Periphery Within Reach CENTER VALLEY, Pa., Jan. 15, 2018 -- (Healthcare Sales & Marketing Network) -- Olympus, a global te... Devices, Product Launch Olympus, PeriView FLEX needle, transbronchial needle aspiration (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - January 15, 2018 Category: Pharmaceuticals Source Type: news

Tracheobronchial foreign bodies in children: the role of emergency rigid bronchoscopy - Baram A, Sherzad H, Saeed S, Kakamad FH, Hamawandi AMH.
Foreign body aspiration (FBA) is a common and lethal accident in the pediatric age group. It requires early recognition and treatment by rigid bronchoscopy to avoid fatal outcomes. OBJECTIVE. The aim of this study was to study the pattern of FBA in... (Source: SafetyLit)
Source: SafetyLit - December 13, 2017 Category: International Medicine & Public Health Tags: Age: Infants and Children Source Type: news

The use of ct-scan in foreign body aspiration in children: a 6 years' experience - Pitiot V, Grall M, Ploin D, Truy E, Ayari Khalfallah S.
INTRODUCTION: A foreign body aspiration is a risky situation, common in pediatric emergency. The "gold standard" to rule out a foreign body or proceed to its extraction, is rigid bronchoscopy (RB) under general anesthesia. However, RB is an intrusive exam ... (Source: SafetyLit)
Source: SafetyLit - November 13, 2017 Category: International Medicine & Public Health Tags: Age: Infants and Children Source Type: news

Bronchoscopy Effective for Diagnosis Only Half the Time Bronchoscopy Effective for Diagnosis Only Half the Time
The diagnostic success of bronchoscopy might not be as high as has been believed, new research warns.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - November 6, 2017 Category: Consumer Health News Tags: Pulmonary Medicine News Source Type: news

Broncus Medical affiliate acquires Uptake Medical
Uptake Medical said yesterday that its InterVapor device for treating emphysema is back on the market in Europe after its acquisition for an undisclosed amount by an affiliate of Broncus Medical. Broncus set its purchase up under a new entity based in Seattle, Uptake Medical Technology, and plans to add markets in Australia and Asia to its commercial footprint in Europe by the end of the year. The InterVapor device uses heated water vapor to reduce lung volume in emphysema patients. Uptake won an expanded CE Mark in the European Union for InterVapor in August 2015. “2018 promises to be an exciting year for ...
Source: Mass Device - September 8, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Mergers & Acquisitions Respiratory Wall Street Beat Broncus Medical Uptake Medical Source Type: news

A Bloody Bronchoscopy A Bloody Bronchoscopy
Bronchoalveolar lavage fluid in a patient presenting with fever, progressive dyspnea and hemoptysis was blood stained with no evidence of infection. Can you crack the case?Thorax (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - September 5, 2017 Category: Consumer Health News Tags: Cardiology Journal Article Source Type: news

An Endoscopic Mask for Fiberoptic Bronchoscopic Intubation An Endoscopic Mask for Fiberoptic Bronchoscopic Intubation
A novel endoscopic mask may be helpful for preventing hypoxia during awake fiberoptic intubation.BMC Anesthesiology (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - August 9, 2017 Category: Consumer Health News Tags: Anesthesiology Journal Article Source Type: news

Inhalation injury caused by cornstarch dust explosion in intubated patients-a single center experience - Hu HC, Chang CH, Hsu HH, Chang CM, Huang CC, Chuang SS, Kao KC.
This study investigated corr... (Source: SafetyLit)
Source: SafetyLit - August 5, 2017 Category: International Medicine & Public Health Tags: Burns, Electricity, Explosions, Fire, Scalds Source Type: news

Auris Surgical reels in $280m in stealthy Series D round
Auris Surgical Robotics has stealthily raised a massive $280 million in a Series D round of financing, according to the company’s website and an SEC filing posted today. Money in the round came from 39 investors, led by newly invested Coatue Management and joined by Mithril, Lux Capital and Highland Capital Partners, according to the filing and the company’s website. The company is looking to raise an additional $4.9 million before closing the round, with the 1st sale recorded on April 5, according to the SEC filing. Auris Surgical is developing a robotic platform with an initial focus on lung cancer, having wo...
Source: Mass Device - August 4, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Robot-Assisted Surgery Robotics Auris Surgical Robotics Source Type: news