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Standards and Certification - Page 2

Stay up to date with the latest Standards and Certification updates from the global medical industry

Boston Scientific wins 510(k) approval for mapping system to diagnose arrhythmia
Thursday, July 25, 2013 Boston Scientific has secured 510(k) approval from US Food and Drug Administration (FDA) to market Rhythmia Mapping System, a 3D mapping and navigation solution that can be used in cardiac...

Elekta’s Clarity 4D Monitoring system for prostate cancer secures CE Mark
Monday, July 22, 2013 Sweden-based Elekta has secured CE Mark for its Clarity 4D Monitoring system, which will allow doctors to monitor the motion of prostate with an accuracy of even sub-millimetre during...

Misonix receives Chinese clearance to market bone-cutting device
Thursday, July 18, 2013 New York-based ultrasonic device manufacturer Misonix has received clearance from China's State Food and Drug Administration (SFDA) to sell its bone-cutting and compression device,...

Rhythmlink wins US patent for slider electrode deployment piece
Wednesday, July 10, 2013 Rhythmlink International, a US-based medical device maker, has secured patent in the US for the design of its slider electrode, an electrode deployment...

AngioDynamics receives 510(k) approval for Xcela Plus Port family
Friday, June 28, 2013 US-based invasive medical devices provider AngioDynamics has received 510(k) approval from the US Food and Drug Administration (FDA) for its Xcela Plus Port family with Pressure Activated...

Sorin Group wins CE mark approval for REPLY 200 family of pacemakers
Thursday, June 20, 2013 Sorin Group, a global medical device company, has received CE mark approval for the REPLY 200 family of pacemakers, which feature sleep apnea monitoring for better management of...

AngioDynamics’ NanoKnife System receives IDE approval for clinical study from US FDA
Wednesday, June 19, 2013 US-based medical devices manufacturer AngioDynamics has secured Investigational Device Exemption (IDE) clearance from the US Food and Drug Administration to carry out a clinical study of...

Staar Surgical’s Visian ICL with CentraFLOW technology wins approval in Korea, Argentina
Tuesday, June 18, 2013 US-based ophthalmic products manufacturer Staar Surgical has secured regulatory clearances in South Korea and Argentina to sell its Visian implantable Collamer lens (ICL) with CentraFLOW...

US FDA recommends manufacturers protect medical devices against cyber attacks
Monday, June 17, 2013 The U.S. Food and Drug Administration has urged medical device makers, hospitals and other medical facilities to boost their protection systems against cyber attacks, which could affect how...

Medtronic wins CE Mark approval for ReDuX plier device
Friday, June 14, 2013 US-based medical device company Medtronic has received CE Mark clearance for its ReDuX plier, an instrument intended for use during...

UK’s MHRA to regulate electronic cigarettes as medicines
Thursday, June 13, 2013 The UK's Medicines and Healthcare products Regulatory Agency (MHRA) is to regulate all products containing nicotine, including electronic cigarettes, as medicines to ensure product safety...

MiMedx receives three new US patents for placental tissue allografts
Thursday, June 13, 2013 MiMedx Group, a US-based manufacturer of regenerative biomaterial products, has received three new patents for placental tissue allografts from the US Patent...

Owen Mumford boosts efficiency and productivity with metrology training
Wednesday, June 12, 2013 UK-based medical devices developer Owen Mumford is using dimensional metrology training to improve its production...

St Jude Medical receives FDA clearance for next generation of high-voltage devices
Wednesday, June 12, 2013 Global medical device company St Jude Medical has received clearance from the US Food and Drug Administration (FDA) for its next-generation Ellipse and SJM Assura portfolio of...

Teleflex secures FDA 510(k) clearance for dialysis catheters
Tuesday, June 11, 2013 Teleflex, a US-based firm that provides medical devices for critical care and surgery, has secured US FDA 510(k) clearance for its Arrow NextStep retrograde femoral length dialysis...

PLC Systems secures US patent for RenalGuard technology
Monday, June 10, 2013 PLC Systems, a provider of medical device technologies, has secured a new method patent entitled 'Patient Hydration Method' from the US Patent and Trademark Office for its RenalGuard therapy...

BioFire secures CE IVD Mark for FilmArray blood culture identification panel
Friday, June 07, 2013 Utah-based BioFire Diagnostics has received the CE IVD Mark for its FilmArray blood culture identification (BCID) panel under the European Directive on in vitro diagnostic medical...

Integrity Applications receives CE Mark approval for GlucoTrack DF-F device
Thursday, June 06, 2013 Israeli medical devices developer Integrity Applications has secured CE Mark approval for its GlucoTrack DF-F, a non-invasive blood glucose monitoring...

EBS Technologies receives CE Mark for brain stimulation device
Thursday, June 06, 2013 EBS Technologies, a medical device firm, has received CE Mark for Next Wave, a brain stimulation device that helps to treat neurological disorders caused by brain injury or...

Medtronic receives FDA, CE clearances for new peripheral balloon catheter
Wednesday, June 05, 2013 US-based Medtronic has received US Food and Drug Administration (FDA) and CE Mark clearances for its Pacific Plus percutaneous transluminal angioplasty (PTA)...

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