New Study of 59,000 patients, presented at EASDec 2016, showed EyeArt 2.0 demonstrating 91 Percent Sensitivity and 90.8 Percent Specificity
Regulatory
Brexit Could Mean Higher Regulatory Hurdles for UK Medical Device Industry
So the deed has been done, UK powers need to get on with the job of leaving the EU, while not actually leaving the EU
New EU Device Regs: No Further Surprises
Changes don’t alter the fact that it’s all about beefing up Notified Bodies and adding stringent Post-Marketing Surveillance… which is good.
FDA Clears SI-BONE’s iFuse Implant System® Updated Indication to Include QOL Claims
iFuse is the only SI Joint Fusion Implant with an FDA cleared indication citing clinical studies that demonstrated improvement in pain, patient function, and quality of life
CE Mark for Ellipsys® Vascular Access System
Vascular Access specialist Avenu Medical gains European approval and closes in on U.S.
Seal of Approval for TissuePatch™ in China
Chinese approval for TissuePatch™ makes it the first and only sealant film to gain access to one of the world’s biggest markets
Last Hurdle Jumped as FDA Approves Integra® Omnigraft™ Dermal Regeneration Matrix Packaging
FDA green light for commercialisation of diabetic foot ulcer graft
FDA Clears EndoGastric Solutions’ Next Generation EsophyX® Device
EsophyX® Z fastener delivery system now requires fewer steps for Transoral Incisionless Fundoplication (TIF) procedures
CE Mark for Planmed Clarity 3D, DBT System
Finnish technology company sees its 3D Tomosynthesis and 2D full field mammography systems ready for EU market
World’s Smallest Pacemaker Gains U.S. Approval
Medtronic’s Micra® TPS is the first transcatheter pacemaker to be approved in the U.S., giving patients access to the most advanced pacing technology at one-tenth the size of traditional devices
CE Mark for St. Jude’s Expanded Selection of Quadripolar Pacing Leads
Cardio device titan will now proceed to EU launch of range adds, claiming largest portfolio of quadripolar leads
Smartinhaler™ Company Sets Stall Out in U.S.
Adherium establishes North American operation and appoints Senior Vice President of Business Development to lead market expansion
Stimwave’s Miniature Peripheral Nerve Stimulator (PNS) Wireless Pain Relief Cleared for Sale
FDA Clears revolutionary tiny device that offers alternative to opioids for chronic pain sufferers
Powdered Medical Glove Ban on the Cards
The days of powdered gloves may well be over, at least in the U.S., as FDA puts out a ban proposal for comment
Consulting Firm Shines Spotlight on Post Market Surveillance
Maetrics reveals how to navigate post market surveillance requirements in free whitepaper
FDA Clears Cochlear’s First Smart Bone Conduction Solution
System works for people with significant mixed hearing loss