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Archive of industry news from the global medical industry

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January 2015

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Agilent gets Chinese approval for SureScan Dx microarray scanner
28 January 2015 US-based Agilent Technologies has received approval from China Food and Drug Administration for its SureScan Dx microarray scanner, as a medical device for in-vitro diagnostic...

Roche's cobas MRSA / SA Test secures FDA 510(k) clearance
28 January 2015 Roche has received 510(k) clearance from US Food and Drug Administration (FDA) for its cobas MRSA / SA Test for early and simultaneous detection of methicillin-resistant Staphylococcus...

FDA approves Dexcom G4 platinum system
27 January 2015 The US Food and Drug Administration (FDA) has granted approval for Dexcom's G4 platinum continuous glucose monitoring system with share...

AliveCor secures CE Mark on atrial fibrillation algorithm for UK and Ireland
26 January 2015 US-based innovator in mobile technology for heart health AliveCor has secured CE Mark clearance for its automated analysis process (algorithm) to detect atrial fibrillation (AF), the most...

Ventana Medical seeks premarket approval from FDA for ALK (D5F3) CDx assay
23 January 2015 Roche Group member Ventana Medical Systems has submitted an application to US Food and Drug Administration (FDA) seeking premarket approval (PMA) for the Ventana ALK (D5F3) companion...

LifeScan launches OneTouch Verio Blood Glucose Monitoring System
23 January 2015 US-based maker of blood glucose monitoring systems LifeScan has launched its new OneTouch Verio Blood Glucose Monitoring System, which enables diabetes patients to easily understand their...

FDA grants 510(k) clearance for Hospira's Plum 360 infusion system
22 January 2015 US Food and Drug Administration (FDA) has granted 510(k) clearance for Hospira's Plum 360 infusion system with Hospira MedNet safety...

NEC Display gets FDA 510(K) clearance for MD210C3 diagnostic monitor
21 January 2015 NEC Display Solutions of America has received 510(K) market clearance from US Food and Drug Administration (FDA) for the MultiSync MD210C3 LCD, a cost-effective display with LED backlighting...

FDA grants PMA-Supplement approval for Flowonix Medical's Prometra II system
21 January 2015 The US Food and Drug Administration (FDA) has granted PMA-Supplement approval for Flowonix Medical's intrathecal infusion device, the Prometra II...

FDA grants 510(k) approval for ECA Medical's disposable spine implant fixation kit
20 January 2015 The US Food and Drug Administration (FDA) has granted 510(k) approval for ECA Medical Instruments' newly developed fully disposable spine implant fixation instrument kit....

Alphaeon and Tracey to market iTrace platform
19 January 2015 US-based Strathspey Crown Holdings' subsidiary Alphaeon has signed a co-promotion agreement with Tracey Technologies to market next-generation iTrace...

Zyno gets CE Mark for Z-800 Infusion system and administration sets
19 January 2015 Zyno Medical has received European CE Mark approval for its Z-800 Infusion system including models Z-800, Z-800F, Z-800W and Z-800WF, and Zyno administration...

FDA grants 510(k) clearance for Signostics' SignosRT Bladder
16 January 2015 The US Food and Drug Administration (FDA) has granted 510(k) clearance for Australian medical device firm Signostics new handheld bladder scanner, SignosRT...

Bellerophon closes patient enrolment in Preservation I trial of BCM
16 January 2015 Bellerophon Therapeutics has completed patient enrolment in its Preservation I CE Mark registration trial of Bioabsorbable Cardiac Matrix (BCM), an investigational implantable medical device...

HeartWare initiates HVAD Lateral study for heart failure patients
15 January 2015 US-based HeartWare International has started the HVAD Lateral Study, a US investigational device exemption (IDE) clinical trial of advanced heart failure patients implanted through a less...

FDA grants 510(k) marketing clearance for IMC's Intact system
14 January 2015 The US Food and Drug Administration (FDA) has granted 510(k) marketing clearance for Intact Medical's (IMC) Intact...

Valorem Surgical gets FDA clearance for MaxiMIS spinal fixation system
14 January 2015 The US Food and Drug Administration (FDA) has granted clearance for medical device firm Valorem Surgical's MaxiMIS Spinal Fixation...

BiO2 Medical secures IDE approval to begin Angel Catheter trial
13 January 2015 US-based medical device manufacturer BiO2 Medical has secured investigational device exemption (IDE) approval from US Food and Drug Administration (FDA) to start a clinical investigation of...

CardioKinetix closes enrolment in Parachute China trial to treat heart failure
12 January 2015 US-based medical device firm CardioKinetix has completed patient enrolment in Parachute China, a multi-centre trial designed to assess the minimally invasive Parachute Ventricular...

Roche's blood screening assay for three viral target detection receives FDA approval
12 January 2015 US Food and Drug Administration (FDA) has approved Switzerland-based Roche's cobas TaqScreen MPX Test, v2.0, designed to simultaneously detect and identify HIV, HCV, and HBV in donations of...

Shockwave secures CE Mark for Lithoplasty system to treat PAD
09 January 2015 Shockwave Medical has received CE Mark approval for its Lithoplasty balloon catheters designed to treat peripheral artery disease...