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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

Natus Neurology's EMG system secures approvals in US and Canada Thursday, August 15, 2013 Natus Neurology has secured regulatory clearances in the US and Canada for its new nerve conduction device, the UltraPro S100 EMG...

Quantel Medical’s glaucoma laser gets US FDA clearance for clinical use Thursday, August 15, 2013 France-based ophthalmic ultrasound and laser devices company Quantel Medical has obtained US Food and Drug Administration (FDA) approval for the clinical use of its selective laser...

Given Imaging’s PillCam SB 3 video capsule receives 510(k) clearance Tuesday, August 13, 2013 Israel-based medical devices developer Given Imaging has got clearance from the US regulatory agency to market its next-generation video capsule PillCam SB 3, which can detect small...

US FDA approves diagnostic test to detect HIV-1 antigen, HIV-1/2 antibodies Friday, August 09, 2013 Orgenics, a subsidiary of Alere, has received the US Food and Drug Administration (FDA) approval for its rapid diagnostic test that can simultaneously detect HIV-1 p24 antigen and antibodies...

CorMatrix Cardiovascular secures patents for biomaterial replacement heart valve in US Thursday, August 08, 2013 CorMatrix Cardiovascular has received three patents in the US for its replacement heart valves that use a biomaterial called extracellular matrix...

Cyberdyne wins German certification for robotic suit to rehabilitate lower body Thursday, August 08, 2013 Cyberdyne, a Japanese robotics and technology company, has received an EC certificate from German safety monitoring agency TÜV Rheinland for its robot suit, called Hybrid Assistive Limb...

Quidel receives 510(k) clearance from US FDA for Sofia hCG FIA Tuesday, August 06, 2013 Diagnostic healthcare solutions manufacturer Quidel has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its Sofia human chorionic gonadotrophin (hCG)...

IMRIS receives CE mark for ceiling-mounted intraoperative computed tomography Tuesday, August 06, 2013 IMRIS, an image-guided therapy solutions provider, has received CE mark for its ceiling-mounted VISIUS intraoperative computed tomography...

Sealantis obtains CE mark for Seal-V bioresorbable sealant Monday, August 05, 2013 Sealantis, an Israel-based developer of protein-free alga-mimetic tissue adhesives, has obtained CE mark for its protein-free bioresorbable sealant...

Ambio Health receives FDA cleared for at-home remote health monitoring system Thursday, August 01, 2013 Ambio Health, a provider of health monitoring systems, has received 510(k) clearance from the US Food and Drug Administration for its Ambio Remote Health Monitoring System, a wireless remote...

Toshiba Medical Systems UK works towards achieving zero waste to landfill Wednesday, July 31, 2013 Toshiba Medical Systems UK (TMS-UK), a unit of Japan-based Toshiba, has minimised its impact on environment through fuel, energy and waste reduction as part of its efforts to achieve 'zero waste...

Teleflex subsidiary receives 510(k) clearance for balloon dilatation catheters Wednesday, July 31, 2013 US-based Teleflex’s subsidiary Hotspur Technologies has received US regulatory clearance to market its ARROW GPSCath balloon dilatation catheters in higher rated burst pressure (RBP) and 80cm...

Stereotaxis wins US clearance to market Vdrive with V-Sono System Tuesday, July 30, 2013 US-based Stereotaxis has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Vdrive Robotic Navigation System with V-Sono Intracardiac Echocardiography (ICE)...

InSightec receives Chinese clearance for ExAblate system to treat uterine fibroids Tuesday, July 30, 2013 Israel-based ultrasound technology provider InSightec has received approval from the Chinese Food and Drug Administration (CFDA) for its non-invasive ExAblate system, which is used in the...

Hologic’s Aptima HPV assay on Panther system approved for cervical cancer screening Thursday, July 25, 2013 Hologic has received US Food and Drug Administration (FDA) approval for its Aptima HPV assay, which can be used on completely automated Panther...

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...

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