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Roche secures FDA approval for Zika virus screening test

Roche has secured approval from the US Food and Drug Administration (FDA) for its cobas Zika test to detect RNA of the Zika virus in human plasma samples.
- Source: medicaldevice-network
- 679
- October 11, 2017
FDA New Approvals plasma Zika
Magenta Medical, Developer of Novel Heart Failure Therapies, Secures $15 Million in Series B Financing

Magenta Medical was founded in October, 2012 by Prof. Ehud Schwammenthal and Mr. Yosi Tuval, Magenta Medical is developing novel therapeutic approaches to the management and treatment of Acute Heart Failure.
- Source: Infomeddnews
- 441
- October 11, 2017
Acute Heart Failure Market Views therapeutic
Synaptive Medical introduces new surgical robotic device

Canadian firm Synaptive Medical has introduced its second-generation, high-powered Modus V digital microscope that has a robotic arm to aid neurosurgery.
- Source: medicaldevice-network
- 584
- October 11, 2017
Company Insight microscope Modus V neurosurgery
AstraZeneca’s Tagrisso Gets Breakthrough Therapy Designation

AstraZeneca announced that the FDA has granted Breakthrough Therapy Designation (BTD) for Tagrisso (osimertinib) for the first-line treatment of patients with metastatic epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC).
- Source: finance.yahoo
- 579
- October 10, 2017
Company Insight EGFR FDA New Approvals NSCLC
Alcon gets CE-Mark for new preloaded IOL delivery system

Novartis’ division Alcon has obtained CE-Mark for its AutonoMe preloaded intraocular lens (IOL) delivery system to accurately deliver the IOL into the capsular bag during cataract surgery. The AutonoMe system is preloaded with a new biomaterial called Clareon IOL that features an advanced design for sharp vision, low edge glare and enhanced optic clarity. With an automated CO2-powered delivery mechanism, the preloaded system is intended to enable accurate single-handed control of IOL placement. Alcon CEO Mike Ball said: “With the introduction of Clareon AutonoMe, we are proud to unveil our latest innovations to benefit doctors and their patients undergoing cataract surgery. “Clareon AutonoMe builds upon the comprehensive legacy of AcrySof by offering cataract surgeons easy, intuitive control of IOL delivery with the newest optic material.” “The intuitive and easy-to-use device is expected to simplify the procedure and minimise surgical time.” The intuitive and easy-to-use device is expected to simplify the procedure ...
- Source: medicaldevice-network
- 536
- October 10, 2017
cataract Company Insight IOL New Approvals
Cardiologs raises $6m in Series A to support ECG Analysis Platform

Cardiologs Technologies said this week it raised $6.4 million in a Series A round of financing to support accelerated commercialization of its Cardiologs ECG Analysis Platform in the US and Europe.
- Source: Massdevice
- 468
- October 10, 2017
Cardiologs Market Views Series
Big Pharma Gets Boost as China Speeds Up New Drug Approvals

For decades, Chinese patients have struggled to gain access to cutting-edge medicines thanks to bureaucratic delays that have hamstrung drug development. Now a sweeping government overhaul of drug approvals is poised to change that.
- Source: bloomberg
- 510
- October 10, 2017
Chinese drug approval Market Views
Cochlear launches iPhone implant sound processor in UK

Implantable hearing solutions provider Cochlear has launched its Nucleus 7 Sound Processor for iPhone cochlear implant in the UK and Ireland markets.
- Source: medicaldevice-network
- 507
- October 9, 2017
Company Insight Implantable hearing solutions iPhone
FDA awards 15 grants for clinical trials to stimulate product development for rare diseases

The U.S. Food and Drug Administration(FDA) announced that it has awarded 15 new clinical trial research grants totaling more than $22 million over the next four years to boost the development of products for patients with rare diseases. These new grants were awarded to principal investigators from academia and industry across the country.
- Source: fda.gov
- 617
- October 9, 2017
Clinical FDA rare diseases Researches
Merck launches frontline PhIII lung cancer study for Keytruda/Yervoy combo

Merck took a dominant position in frontline lung cancer with the approval of a combination of Keytruda and chemo. And it isn’t just waiting around to see if any combination of a PD-(L)1 with a CTLA4 can come along and knock it off its market-leading perch.
- Source: Endpts
- 615
- October 9, 2017
cancer Clinical Trials lung Phase

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