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July 2016

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Relievant Medsystems gets FDA 510(k) clearance for INTRACEPT system to treat CLBP 25 July 2016 US-based medical device company Relievant Medsystems has secured the US Food and Drug Administration (FDA) 510(k) clearance for its INTRACEPT intraosseous nerve ablation system to treat...

Cytox launches genetic biomarker assay for research use and Alzheimer’s disease risk assessment 25 July 2016 UK-based medical technology company Cytox has launched its genetic biomarker research assay variaTECT for research use and to assess Alzheimer’s disease (AD)...

Viracor-IBT gets FDA emergency use authorisation of Zika Virus Real-time RT-PCR assay 22 July 2016 Eurofins Scientific’s subsidiary Viracor-IBT Laboratories (Viracor-IBT) has received emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its Zika Virus...

Deals this week: Teva Pharmaceutical, Euroimmun AG, T2 Biosystems 22 July 2016 Teva Pharmaceutical Industries, through its financial arm Teva Pharmaceutical Finance Netherlands, has announced a public placement of 3.15% senior notes due...

M&As this week: Zimmer Biomet Holdings, Sartorius AG, Straumann Holding 22 July 2016 Zimmer Biomet Holdings, through its wholly-owned subsidiary, has acquired 1,406,151 shares of Medtech SA, a surgical robot company, from Ally Bridge Group at a price €50 ($55.15) a share....

Cydar secures FDA 510(k) clearance for 3D surgical guidance software 22 July 2016 UK-based Cydar Medical has secured the US Food and Drug Administration (FDA) 510(k) clearance for its EV surgical guidance software to be used for x-ray guided vascular...

Vasorum gets FDA approval for Celt ACD arterial closure device 22 July 2016 Irish medical device research and development firm Vasorum has secured premarket approval (PMA) from the US Food and Drug Administration (FDA) for its arterial puncture closure device Celt ACD...

Precision NanoSystems unveils NanoAssemblr Spark system for nanomedicine development 21 July 2016 Canada-based Precision NanoSystems (PNI) has unveiled the NanoAssemblr Spark system to assist the development of nucleic acid-based nanomedicines, including mRNA and CRISPR/Cas9...

Contego finishes patient enrolment for Paladin Clinical Registry 21 July 2016 US-based medical device company Contego Medical has completed enrolling patients in its study of the Paladin Carotid Post­-Dilation Balloon System in Europe to offer an interventional treatment...

Inova gets FDA 510(k) clearance for QUANTA Flash dsDNA, Jo-1, and Scl-70 assays 21 July 2016 US-based in-vitro diagnostics company Inova Diagnostics has secured the US Food and Drug Administration (FDA) 510(k) clearance for its QUANTA Flash dsDNA, Jo-1, and Scl-70...

Medrobotics reports positive clinical study data of Flex Robotic System 20 July 2016 US-based medical device company Medrobotics has reported positive clinical data of its Flex Robotic System in providing an enhanced surgical...

DePuy Synthes and Materialise to introduce TRUMATCH titanium 3D-printed implants 20 July 2016 US-based medical device company DePuy Synthes has entered into an agreement with 3D printing company Materialise to introduce TRUMATCH titanium 3D-printed implants for facial and skull...

IlluminOss finishes enrollment for US clinical trial of IlluminOss System for bone stabilisation 20 July 2016 IlluminOss Medical has completed patient enrollment in its first US clinical trial in a bid to seek approval from the US Food and Drug Administration (FDA) for its IlluminOss System to...

Roche confirms effiicacy of CoaguChek XS System for patients on anticoagulation therapy 19 July 2016 US-based medical device company Roche has confirmed the safety and efficacy of the CoaguChek XS System for use by healthcare professionals at point of care and for patients to conduct self-tests...

Soberlink secures 510(k) premarket clearance from FDA for breathalyser 19 July 2016 Soberlink has secured 510(k) premarket clearance from the US Food and Drug Administration (FDA) for medical use of Breathalyser by healthcare providers to remotely measure alcohol levels in...

Terumo completes acquisition of Sequent Medical for $280m 18 July 2016 MicroVention, a fully-owned unit of Japan-based Terumo Corporation, has completed the purchase of Sequent Medical , a privately-held medical device firm based in Aliso Viejo,...

Bayer introduces pain relief Aleve Direct Therapy 18 July 2016 Medical device company Bayer has introduced pain relief device Aleve Direct Therapy in the...

Fisher Center scientists develop 3D visualisation of brain defects causing Alzheimer's disease 18 July 2016 Fisher Center scientists have created imaging technology that enables 3D visualisation of brain defects that cause Alzheimer's...

Deals this week: Diaxonhit SA, Trovagene, Avizia 15 July 2016 Diaxonhit SA, a specialty diagnostic solutions provider, has signed an exclusive distribution agreement in France with Advanced Biological Laboratories (ABL), a medical data technology...

Taris begins Phase Ib trial of TAR-200 to treat MIBC 15 July 2016 US-based medical device company Taris Biomedical has begun the Phase Ib clinical trial of TAR-200 (GemRIS) in patients with muscle-invasive bladder cancer...

Report: Global trauma fixation market to grow at a CAGR of 2.2% by 2022 15 July 2016 The global trauma fixation market is predicted to grow at a compound annual growth rate (CAGR) of 2.2% to reach $7.41bn by 2022, a marginal increase from $6.4bn in 2015, according to a...


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