ExThera Medical Closes Financing Led By Fresenius Medical Care Ventures To Support Commercialization Of Innovative Technology To Remove Pathogens From Whole Blood
ExThera Medical Corporation, the leading developer of innovative blood filtering technology to address major global health problems, recently announced that the company has closed a Series B financing round with an equity investment led by new investor Fresenius Medical Care Ventures GmbH (Source: Medical Design Online News)
Source: Medical Design Online News - June 3, 2016 Category: Medical Equipment Source Type: news
K2M Enhances 3D-Printed Spine Portfolio Following FDA Clearance Of Two CASCADIA™ Interbody Systems Featuring Lamellar 3D Titanium Technology™
K2M Group Holdings, Inc.(NASDAQ:KTWO) (the "Company" or "K2M"), a global medical device company focused on designing, developing and commercializing innovative and proprietary complex spine and minimally invasive spine technologies and techniques, today announced it has received 510(k) clearances from the U.S. Food and Drug Administration (FDA) to market theCASCADIA™Cervicaland theCASCADIA AN Lordotic ObliqueInterbody Systems featuringLamellar 3D Titanium Technology™, the Company's innovative technology that uses 3D printing with the goal of allowing for bony integration throughout an im...
Source: Medical Design Online News - June 3, 2016 Category: Medical Equipment Source Type: news
Additive Orthopaedics Announces The 510(k) Clearance Of Their 3D Printed Digital Fusion Implant For The Global Extremities Market
Additive Orthopaedics, LLC., an early stage orthopaedic device company, today announced that is has received FDA 510(k) clearance for its 3D printed titanium digital fusion implant, to address the over 1.1M US fusion procedures annually. (Source: Medical Design Online News)
Source: Medical Design Online News - June 3, 2016 Category: Medical Equipment Source Type: news
Oticon Opn With BrainHearing Technology Helps People With Hearing Loss Hear Better, With Less Effort And Better Recall
Approximately 20 percent of Americans experience hearing loss, according to the Hearing Loss Association of America. (Source: Medical Design Online News)
Source: Medical Design Online News - June 3, 2016 Category: Medical Equipment Source Type: news
Ebola Test From J&J's Janssen Earns FDA Emergency Use Authorization
The FDA has issued emergency use authorization (EUA) for Johnson & Johnson (J&J) subsidiary Janssen’s real-time diagnostic device indicated for the Ebola Zaire virus, which was responsible for the 2014 outbreak in West Africa. Using only a few drops of blood, the device can deliver results in less than two hours, and its cartridges are designed for easy transit and safe disposal. (Source: Medical Design Online News)
Source: Medical Design Online News - June 2, 2016 Category: Medical Equipment Source Type: news
Lessons Learned From Year One Of The FDA's Expedited Access Pathway
During the first year of the program, FDA officials report that the agency has made 29 decisions on requests for EAP designation: 17 have been accepted into the program, and 12 have been denied. These decisions were typically made in 30 days. (Source: Medical Design Online News)
Source: Medical Design Online News - June 2, 2016 Category: Medical Equipment Source Type: news
FDA Guidance Updates Categorization Policy For IDEs, Expedites CMS Coverage
The FDA has issued a guidance that would streamline and clarify the categorization process for investigational device exemptions (IDEs). While the Advanced Medical Technology Association (AdvaMed) is still reviewing the document, a spokesperson commented that updated policies would expedite Centers for Medicare and Medicaid Services (CMS) coverage and increase patient access to new technology and enrollment in FDA-approved clinical trials. (Source: Medical Design Online News)
Source: Medical Design Online News - June 2, 2016 Category: Medical Equipment Source Type: news
Myriad Acquires Sividon Diagnostics
Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular diagnostics and personalized medicine, today announced that it has acquired Sividon Diagnostics, a leading breast cancer prognostic company, for €35 million upfront with the potential for €15 million in additional performance-based milestones. (Source: Medical Design Online News)
Source: Medical Design Online News - June 2, 2016 Category: Medical Equipment Source Type: news
Nestlé Health Science Collaborates With DBV Technologies To Accelerate Development Of An Innovative Diagnostic Tool For Cow's Milk Protein Allergy
Nestlé Health Science recently announced that it has entered into a strategic collaboration with DBV Technologies, headquartered in Montrouge, France, aimed at developing and bringing to market DBV’s innovative patch-test tool for the diagnosis of Cow’s Milk Protein Allergy (CMPA) in infants. (Source: Medical Design Online News)
Source: Medical Design Online News - June 2, 2016 Category: Medical Equipment Source Type: news
Phillips-Medisize Acquires Medicom
Phillips-Medisize Corporation (the “Company”) recently announced that it has acquired Medicom Innovation Partner (“Medicom”), a leading provider of device strategy, product design and development services with particular focus on personal connected health drug delivery device solutions to meet the needs of the rapidly growing biopharma and specialty pharmaceutical markets. Terms of the transaction were not disclosed. (Source: Medical Design Online News)
Source: Medical Design Online News - June 2, 2016 Category: Medical Equipment Source Type: news
Philips Teams Up With Leading Innovators In Interventional Oncology
Royal Philips (NYSE: PHG, AEX: PHIA) today announced that as part of the existing Master Research Agreement with Yale School of Medicine, it has entered into a new research program led by Prof. Jeff Geschwind, chair of Radiology and Biomedical Imaging at Yale School of Medicine, to innovate in interventional oncology. (Source: Medical Design Online News)
Source: Medical Design Online News - June 2, 2016 Category: Medical Equipment Source Type: news
Stryker, Olympus Lead South Korea Surgical Camera System Market Through Continued Innovation
According to a new series of reports on the South Korean market for hybrid and integrated operating room equipment by iData Research, High Definition (HD) camera systems have become the operating room standard in South Korea, which has created competition, causing the average selling price (ASP) to decrease. (Source: Medical Design Online News)
Source: Medical Design Online News - June 2, 2016 Category: Medical Equipment Source Type: news
Medtronic Execs Pin Growth Plans On Diabetes, Robotic Surgery
After reporting a $1 million loss for the same period one year earlier, Medtronic defied analysts’ expectations to bounce back and earn $1.1 billion in the fourth quarter ended April 29, boosted by the acquisition of Covidien. Strong demand for cardiovascular and diabetes device sales paced all product segments during the period. (Source: Medical Design Online News)
Source: Medical Design Online News - June 1, 2016 Category: Medical Equipment Source Type: news
First PT/INR Home Self-Testing Device With Bluetooth Technology Enabling Remote Care Programmes For Anticoagulated Patients
Roche announced recently that it has launched the CoaguChek INRange system in countries accepting the CE Mark. (Source: Medical Design Online News)
Source: Medical Design Online News - June 1, 2016 Category: Medical Equipment Source Type: news
