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

TSO3 files FDA app seeking duodenoscope indication for Sterizone VP4 sterilizer
TSO3 said today it filed a 510(k) application with the FDA as it seeks to clear its Sterizone VP4 sterilizer for the terminal sterilization of duodenoscopes used in endoscopic retrograde cholangio-pancreatography procedures. The company’s Sterizone VP4 is a low-temperature sterilization system which uses dual-sterilants of vaporized hydrogen peroxide and ozone for the terminal sterilization of heat and moisture sensitive medical devices. The system has a single pre-programmed cycle which can be used to sterilize a wide range of devices, the Quebec City-based company said. TSO3 said that if awarded, the approval would...
Source: Mass Device - July 20, 2017 Category: Medical Devices Authors: Fink Densford Tags: Food & Drug Administration (FDA) Regulatory/Compliance Sterilization / Calibration TSO3 Source Type: news

FDA clears Custom Ultrasonics to resume manufacturing System 83 endoscope washer-disinfector
Custom Ultrasonics said yesterday that the FDA inspected and cleared its manufacturing facility in Ivyland, Penn, reinstating the manufacturing, packing and distribution of the company’s System 83 Plus washer and disinfector for use with non-duodenoscope endoscopes. The Philadelphia-based company said that it was required to perform independent validation testing for its System 83 Plus water filtration system and its inline disc filter, which the FDA approved with no changes to the design. New validations were also required for processing bronchoscopes and non-GI endoscopes which all met specified performance cr...
Source: Mass Device - June 27, 2017 Category: Medical Devices Authors: Fink Densford Tags: Endoscopic / Arthroscopic Food & Drug Administration (FDA) Sterilization / Calibration Custom Ultrasonics Source Type: news

Boston Scientific launches Alair asthma treatment in India
Boston Scientific (NYSE:BSX) has launched its Alair bronchial thermoplasty therapy in India, according to an India Blooms report. The device won clearance in the country with indications for treating severe, persistent, drug-resistant asthma in adult patients who’s asthma is not well controlled with inhaled corticosteroids and long acting beta antagonists. Marlborough, Mass.-based Boston Scientific’s Alair bronchial thermoplasty treatment uses a bronchoscope to deliver radiofrequency energy to reduce the amount of excess smooth muscle tissue in the airways. “There are over 18 million estimated a...
Source: Mass Device - June 13, 2017 Category: Medical Devices Authors: Fink Densford Tags: Regulatory/Compliance Respiratory Boston Scientific Source Type: news

Foreign body aspiration in children: a study of children who lived or died following aspiration - Mohammad M, Saleem M, Mahseeri M, Alabdallat I, Alomari A, Za'atreh A, Qudaisat I, Shudifat A, Nasri Alzoubi M.
Foreign body aspiration (FBA) is a preventable cause of mortality and morbidity in children. We conducted a chart review of children who presented to a university hospital due to FBA in the period 1999-2014. Children were either managed with bronchoscopy f... (Source: SafetyLit)
Source: SafetyLit - June 8, 2017 Category: International Medicine & Public Health Tags: Age: Infants and Children Source Type: news

MassDevice.com +5 | The top 5 medtech stories for May 24, 2017
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry. Get this in your inbox everyday by subscribing to our newsletters.   5. Feds charge ex-Medicare employees with insider trading Former employees at the Centers for Medicare & Medicaid Services used confidential information on Medicare reimbursement changes for radiation treatments and dialysis i...
Source: Mass Device - May 24, 2017 Category: Medical Devices Authors: MassDevice Tags: News Well Plus 5 Source Type: news

Boston Scientific ’ s post-approval Alair study shows long-term asthma improvement
Patients treated with the Alair device made by Boston Scientific (NYSE:BSX) showed long-term improvement in controlling their asthma, according to a post-approval study released today at the annual meeting of the American Thoracic Society in Washington. The Alair bronchial thermoplasty treatment uses a bronchoscope to deliver radiofrequency energy to reduce the amount of excess smooth muscle tissue in the airways. Boston acquired the technology when it paid $194 million in cash for Asthmatx in 2010, shortly after that company won 510(k) clearance from the FDA for Alair. The deal also included some $250 million in pote...
Source: Mass Device - May 24, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Clinical Trials Respiratory Wall Street Beat Boston Scientific Source Type: news

7 medtech stories we missed this week: May 19, 2017
[Image from unsplash.com]From FDA clearances to touting study data, here are 7 medtech stories we missed this week but thought were still worth mentioning. 1. XpandOrtho wins FDA 510(k) clearance XpandOrtho announced in a May 17 press release that it has received FDA 510(k) clearance for its electronic soft tissue balancing instrument for total knee replacement surgery. The sterile-packaged wireless disposable device uses miniature sensors and actuators to balance knee joints during full-range motions. Using constant pressure bellows systems, the device communicates with a display for multiaxial balance and selection of th...
Source: Mass Device - May 19, 2017 Category: Medical Devices Authors: Danielle Kirsh Tags: 510(k) Clinical Trials Food & Drug Administration (FDA) Regulatory/Compliance Research & Development Body Vision Medical Exactech Inc. Lombard Medical Technologies MedTech NxThera Inc. Rivanna Medical Visionsense XpandOrtho Source Type: news

Dentistry researcher receives a $2.5M grant to validate liquid biopsy test for lung cancer
In an effort to move the needle forward to improve cancer detection techniques, the National Cancer Institute awarded $2.5 million over a period of five years to principal investigator,Dr. David Wong,  a professor of oral biology and associate dean for research at the UCLA School of Dentistry. The grant will support a clinical trial to validate the research team’s liquid biopsy test, a rapidly emerging technology, with the goal to have it become a certified service at UCLA and beyond.For this project, the dental school is partnering with the UCLA Department of Pathology and Lab Medicine, led by Dr. Scott Binder,...
Source: UCLA Newsroom: Health Sciences - March 30, 2017 Category: Universities & Medical Training Source Type: news

Dilatational Tracheotomy Using the Rigid Endoscope Dilatational Tracheotomy Using the Rigid Endoscope
Is the use of a rigid tracheotomy endoscope a feasible alternative to fiberoptic tracheo-bronchoscopy for dilational tracheotomy?BMC Anesthesiology (Source: Medscape Critical Care Headlines)
Source: Medscape Critical Care Headlines - March 22, 2017 Category: Intensive Care Tags: Anesthesiology Journal Article Source Type: news

Network Modeling Could Optimize End-Stage Emphysema Tx
(MedPage Today) -- Model suggests similar outcomes with surgical, bronchoscopic lung volume reduction (Source: MedPage Today Pulmonary)
Source: MedPage Today Pulmonary - February 10, 2017 Category: Respiratory Medicine Source Type: news

Single-use bronchoscopes appear cost  effective in USA
(Source: PharmacoEconomics and Outcomes News)
Source: PharmacoEconomics and Outcomes News - January 31, 2017 Category: Drugs & Pharmacology Source Type: news

My Macgyver Moment
  Since emergency physicians are the MacGyvers of medicine – mullet not included – we asked our readers to send in their best stories of improvising on the fly. What did you do when you were fighting against the clock and couldn’t find the supplies you needed? Here are our four winning entries, with comments by Ken Iserson, MD, author of Improvised Medicine. Published entrants gain free admittance to Blood and Sand, a tropical CME in Atlantis, Bahamas. For a chance to win, send your best MacGyver Moment to lplaster@epmonthly.com Give Me a Hand(stand) by Andrew Langsam I was getting ready to go...
Source: EPMonthly.com - December 31, 2016 Category: Emergency Medicine Authors: Matt McGahen Tags: Uncategorized Source Type: news

Creo Medical looks to raise $25m in UK IPO
U.K.-based electrosurgery device developer Creo Medical said today it looks to raise $25.3 million (UK £20 million) in a U.K. initial public offering, expected to take place on December 9. Creo Medical said it plans to offer shares at approximately 97¢ per share (UK £0.79), while the company has an estimated market capitalization of approximately $77.7 million (UK £61.3 million). The company is developing minimally invasive surgical devices, initially focused on gastrointestinal surgery and lung cancer, using the company’s Croma system which combines bipolar radiofrequency and microwave en...
Source: Mass Device - December 6, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Initial Public Offering (IPO) Surgical Creo Medical Source Type: news

MassDevice.com +5 | The top 5 medtech stories for November 8, 2016
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry. Get this in your inbox everyday by subscribing to our newsletters.   5. Stanford uses CRISPR to correct sickle cell, human trials planned Researchers from the Stanford University School of Medicine have reportedly used CRISPR, a gene-editing tool, to repair the gene that causes sickle cell disease....
Source: Mass Device - November 8, 2016 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 5 Source Type: news

Positive 1-month safety results for Medtronic ’ s Navigate bronchoscopy trial
Medtronic (NYSE:MDT) today released 1-month data from the Navigate trial of its superDimension LungGPS system, touting the device as safe and effective based on the preliminary results. A total of 1,289 patients have been enrolled in the trial to date, which spans 37 sites across Europe and North America. The trial looks to evaluate the performance of Fridley, Minn.-based Medtronic’s LungGPS electromagnetic navigation bronchoscopy technology the SuperDimension device uses to navigate the lungs. The initial data comes from 500 procedures, 497 of which were lung lesion biopsies, 91 for fiducial placement and 9 for dye ...
Source: Mass Device - November 8, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Clinical Trials Imaging Respiratory Medtronic Source Type: news

First Glimpse of NAVIGATE Bronchoscopy Results Is Promising First Glimpse of NAVIGATE Bronchoscopy Results Is Promising
Interim results from the more than 1200 patient NAVIGATE trial in North America and Europe suggest that electromagnetic navigation bronchoscopy can be safely used to evaluate lung lesions.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - November 7, 2016 Category: Consumer Health News Tags: Pulmonary Medicine News Source Type: news

My Macgyver Moment
Since emergency physicians are the MacGyvers of medicine – mullet not included – we asked our readers to send in their best stories of improvising on the fly. What did you do when you were fighting against the clock and couldn’t find the supplies you needed? Here are our four winning entries, with comments by Ken Iserson, MD, author of Improvised Medicine. Published entrants gain free admittance to Blood and Sand, a tropical CME in Atlantis, Bahamas. For a chance to win, send your best MacGyver Moment to lplaster@epmonthly.com Give Me a Hand(stand) by Andrew Langsam I was getting ready to go on a lo...
Source: EPMonthly.com - September 19, 2016 Category: Emergency Medicine Authors: Matt McGahen Tags: Uncategorized Source Type: news

Bronchoscopy
Title: BronchoscopyCategory: Procedures and TestsCreated: 2/8/2000 12:00:00 AMLast Editorial Review: 8/25/2016 12:00:00 AM (Source: MedicineNet Lungs General)
Source: MedicineNet Lungs General - August 25, 2016 Category: Respiratory Medicine Source Type: news

ATS Releases Guidelines for Evaluating Infant Wheeze
(MedPage Today) -- Bronchoscopy, BAL, and 24-hour pH monitoring may be useful (Source: MedPage Today Pediatrics)
Source: MedPage Today Pediatrics - August 2, 2016 Category: Pediatrics Source Type: news

Auris Enters Robotic Surgery Market With FDA Nod For Bronchoscope
Auris Surgical Robotics, a California-based startup, has secured FDA approval for a bronchoscope as part of the Auris Robotic Endoscopy System (ARES); it is the company’s first surgical robot cleared for the U.S. market. (Source: Medical Design Online News)
Source: Medical Design Online News - June 10, 2016 Category: Medical Equipment Source Type: news

MassDevice.com +5 | The top 5 medtech stories for June 8, 2016
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry. Get this in your inbox everyday by subscribing to our newsletters.   5. FDA releases May 2016 510(k) clearances The Food & Drug Administration released the 510(k) clearances it issued in May 2016. Read more 4. Google’s Verily Star Trek “Tricorder” moonshot flops Verily&r...
Source: Mass Device - June 8, 2016 Category: Medical Equipment Authors: MassDevice Tags: Business/Financial News Plus 5 Source Type: news

FDA clears Ares robot-assisted bronchoscopy device from Auris Surgical Robotics
The FDA last month granted 510(k) clearance to the Ares robot-assisted bronchoscopy platform developed by stealthy Auris Surgical Robotics. San Carlos, Calif.-based Auris was co-founded by medical robotics pioneer Dr. Frederic Moll, who’s behind a slew of other startups in the space, including market leader Intuitive Surgical (NSDQ:ISRG); Mako Surgical, acquired in 2013 for $1.7 billion by Stryker (NYSE:SYK); Restoration Robotics and its Artas hair restoration platform; and Hansen Medical, which Auris agreed to acquire for $80 million in April. Auris revealed in a Septembe...
Source: Mass Device - June 8, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Regulatory/Compliance Respiratory Robot-Assisted Surgery Auris Surgical Robotics Source Type: news

FDA releases May 2016 510(k) clearances
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD May 2016 TOTAL 510(k)s THIS PERIOD 213 TOTAL WITH SUMMARIES 205 TOTAL WITH STATEMENTS 8 May 2016 510(k) Clearances SHARE TWEET LINKEDIN PIN IT EMAIL PRINT 510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD May 2016 DEVICE: O-PEP PARI RESPIRATORY EQUIPMENT, INC. 510(k) NO: K150044(Traditional) ATTN: Michael Judge PHONE NO : 1 804 2537274 2412 PARI Way SE DECISION MADE: 27-MAY-16 Midlothian VA 23112 510(k) SUMMARY AVAILABLE FROM FDA ...
Source: Mass Device - June 8, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news

The real costs of clinical research
In 1996 The University of Rochester was offering $150 to volunteers for what was designed to be a minimal-risk research study. To 19-year-old Nicole (Hoiyan) Wan, a hundred and fifty dollars meant being able to afford a trip home to see her parents in Queens, New York. Nicole, like many college students, found the money offered on a campus flier for participation in the clinical research study to be extremely enticing. Back in Queens, New York, Mr. and Mrs. Wan were unaware of their daughter’s intention to enroll in any study. The study was focused on the mechanism by which the lungs defend against infection and poll...
Source: Mass Device - June 7, 2016 Category: Medical Equipment Authors: MassDevice Tags: Blog IMARC Source Type: news

Clinical Software brings precision imaging to pulmonologists.
Built specifically for pulmonary clinician, VIDA|vision™ provides insights to optimize care decisions and improve patient outcomes. Lung Bronchoscopy Planning focuses interventional pulmonologists on planning and performing diagnostic biopsy procedures for peripheral nodule. Lung Volume Reduction provides physicians with information to select appropriate therapy for severe emphysema patients, using evidence-based quantitative CT biomarkers to include heterogeneity and fissure integrity....This story is related to the following:Search for suppliers of: Medical Diagnostic Equipment (Source: Industrial Newsroom - He...
Source: Industrial Newsroom - Health, Medical and Dental Supplies - May 18, 2016 Category: Medical Equipment Source Type: news