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September 2016

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NovaBone secures CE mark for collagen wound dressing products 28 September 2016 US-based biologics medical device company NovaBone has secured CE mark approval for its two dental wound dressing products, NovaTape and...

Roche's Treponema pallidum assay gets FDA 510(k) clearance for syphilis infection diagnosis 28 September 2016 Roche has secured the US Food and Drug Administration (FDA) 510(k) clearance for its fully automated assay for the diagnosis of syphilis...

Natus agrees to acquire GN Otometrics for $145m 27 September 2016 US-based medical device company Natus has agreed with GN Store Nord to acquire GN Otometrics from GN Hearing for...

Vela Diagnostics gets FDA emergency use authorisation for Sentosa SA ZIKV PCR Test 27 September 2016 Vela Diagnostics has obtained Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for its Sentosa SA ZIKV PCR...

Qfix to unveil radiotherapy treatment equipment at ASTRO 27 September 2016 US-based radiotherapy device maker Qfix is set to unveil a suite of radiotherapy treatment equipment during the American Society for Radiation Oncology (ASTRO) in Boston, Massachusetts,...

Seno Medical reports positive interim data from Maestro study of breast imaging system 26 September 2016 US-based medical imaging company Seno Medical has reported positive interim results from its MAESTRO study of Imagio opto-acoustic (OA) a breast imaging system used to detect breast...

ZDi Solution to introduce Z-System patient positioning devices to radiation oncology market 26 September 2016 US-based medical device manufacturer ZDi Solutions will introduce its Z-System patient positioning devices to proton therapy and conventional radiation therapy facilities in the...

Staar Surgical gets approval to distribute EVO Visian Toric ICL in Canada 26 September 2016 US-based medical device company Staar Surgical has obtained approval from the Medical Devices Bureau of Health Canada to distribute EVO Visian Toric ICL in the...

M&As this week: Allergan, Instrumentation Laboratory (IL), Johnson & Johnson (J&J) 23 September 2016 Global pharmaceutical company, Allergan, intends to acquire Tobira Therapeutics, a clinical-stage bio-pharma company, for an approximate consideration of...

Royal Philips introduces patient experience solution on IBA proton therapy gantries 23 September 2016 Royal Philips has introduced its patient-centric Ambient Experience solution for Ion Beam Applications' (IBA) proton therapy...

Mevion unveils pencil beam scanning technology at ASTRO 2016 23 September 2016 US-based Mevion Medical Systems has unveiled its pencil beam scanning Hyperscan with Adaptive Aperture at the 2016 ASTRO Annual Meeting in Boston,...

Deals this week: FenoLogica Biosciences, CareDx, NuSirt Biopharma 23 September 2016 FenoLogica Biosciences, a life sciences company based in Seattle, Washington, US, has signed a licensing and collaboration agreement with Pacific Northwest Research Institute (PNRI), a...

BD launches BD Veritor Plus diagnostic system 22 September 2016 Becton, Dickinson and Company (BD), a global medical technology company, has launched a wireless rapid diagnostic system, BD Veritor Plus, which detects influenza A and B, respiratory...

FDA grants 510(k) clearance for Heidelberg's Spectralis OCT Glaucoma Module Premium Edition 22 September 2016 The US Food and Drug Administration (FDA) has granted 510(k) clearance to Heidelberg Engineering to market its Spectralis Optical Coherence Tomography (OCT) Glaucoma Module Premium...

GI View's Aer-O-Scope Colonoscope System receives FDA 510(k) clearance 21 September 2016 Israel-based GI View has secured the US Food and Drug Administration (FDA) 510(k) clearance for its Aer-O-Scope Colonoscope...

Versa Capital Management acquires medical technology firm SynCardia 21 September 2016 US-based private equity investment firm Versa Capital Management has acquired medical technology company SynCardia Systems as part of the latter's previously announced reorganisation...

Beckman Coulter installs DxH 500 compact haematology analyser in UK 20 September 2016 US-based biomedical laboratory instruments maker Beckman Coulter has installed the first DxH 500 haematology analyser in the University of Chester’s Institute of Medicine on the Countess of...

Keystone Heart reports positive outcome of TriGuard Cerebral Embolic Protection device for TAVR 20 September 2016 Israel-based medical device company Keystone Heart has reported positive data from its TriGuard Cerebral Embolic Protection device while it was used during transcatheter aortic valve...

QT Vascular gets IDE approval from FDA for Chocolate Touch drug-coated balloon 20 September 2016 Singapore-based QT Vascular has obtained investigational device exemption (IDE) from the US Food and Drug Administration (FDA) to conduct the US pivotal trial of its Chocolate Touch...

Shockwave Medical gets FDA approval for Lithoplasty System to treat calcified peripheral artery disease 19 September 2016 Shockwave Medical has secured clearance from the US Food and Drug Administration (FDA) for the Lithoplasty System intended for the treatment of calcified plaque in patients with peripheral...

Iqarus opens first responders training centre in UK 19 September 2016 Iqarus intelligent health solutions has opened a training centre in Hereford, UK to enhance the capability of first responders and healthcare professionals in addressing high-risk and...