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 commer...
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 < 6 years.
Lying within or adjacent to the DNS are numerous bones, blood vessels, nerves and other soft tissues. The spaces communicate between each other and therefore spreading can also occur ...
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 the new ...
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 mak...
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 criter...
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 asthmatic...
Source: Mass Device - June 13, 2017 Category: Medical Devices Authors: Fink Densford Tags: Regulatory/Compliance Respiratory Boston Scientific Source Type: news
