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clinica
Featured
29 June 2016
 
28 June 2016
While the UK and the EU struggle to comprehend the full implications of the UK’s decision to leave the European Union, Amanda Maxwell considers the implications for the implementation of the future Medical Devices and IVD Regulations, including the ...
27 June 2016
HeartWare has found a way to pay for the expanded commercialization of its HVAD ventricular assist device and the development of its MVAD miniaturized ventricular assist device; the Boston-area VAD-maker has agreed be acquired by medtech giant ...
27 June 2016
The US market for interventional cardiology products, which includes diagnostic and therapeutic products, is anticipated to expand from an estimated $3.3 billion in 2015 to roughly $3.6 billion in total product sales by the year 2020. One bright ...
27 June 2016
June 23 2016 will go down in history for UK Prime Minister David Cameron : the day his decision to call the bluff of his Conservative Party’s anti-EU clique came back to bite him on the backside. Ex-Prime Minister, we should say, as it turns out ...
 
27 June 2016
The US market for interventional cardiology products, which includes diagnostic and therapeutic products, is anticipated to expand from an estimated $3.3 billion in 2015 to roughly $3.6 billion in total product sales by the year 2020. One bright ...
23 June 2016
Elekta last year set off on what it hoped was a path to recovery, after reporting significantly below-par results for fiscal 2015 under the watch of the then-CEO Niklas Savander. The Swedish cancer treatment specialist unveiled a comprehensive ...
22 June 2016
Cardica is now Dextera Surgical – the second name change in the company’s 19-year history – to reflect its broadening focus in minimally invasive and robotic-assisted surgery. The Redwood City, California firm said it will continue to market its ...
21 June 2016
Marking its maiden M&A deal in digital pathology, Philips has acquired PathXL, a Northern Ireland company specializing in image analysis, work flow software and educational tools. The deal is expected to enable Philips to offer products that will ...
 
28 June 2016
Clearbridge Accelerator, a Singapore-based technology incubator and investor, is teaming up with product design and development specialist Cambridge Consultants to accelerate the route to market for start-ups in the Asian region and beyond. With ...
27 June 2016
The US market for interventional cardiology products, which includes diagnostic and therapeutic products, is anticipated to expand from an estimated $3.3 billion in 2015 to roughly $3.6 billion in total product sales by the year 2020. One bright ...
23 June 2016
Elekta last year set off on what it hoped was a path to recovery, after reporting significantly below-par results for fiscal 2015 under the watch of the then-CEO Niklas Savander. The Swedish cancer treatment specialist unveiled a comprehensive ...
23 June 2016
Calling the US 2.3% device excise tax "punitive" and "job-killing," House Speaker Paul Ryan, R-Wisc., promised to permanently repeal the tax on June 22, along with the Independent Payment Advisory Board, CMS Innovation Center, and some other key ...
 
28 June 2016
While the UK and the EU struggle to comprehend the full implications of the UK’s decision to leave the European Union, Amanda Maxwell considers the implications for the implementation of the future Medical Devices and IVD Regulations, including the ...
27 June 2016
June 23 2016 will go down in history for UK Prime Minister David Cameron : the day his decision to call the bluff of his Conservative Party’s anti-EU clique came back to bite him on the backside. Ex-Prime Minister, we should say, as it turns out ...
24 June 2016
Minutes from the most recent Medical Device User Fee Act negotiation meeting, posted by the US FDA, suggest regulators and industry are getting closer to agreeing on components of a MDUFA IV proposal. Returning to the negotiating table on May 16, ...
24 June 2016
So that's it. After months of discussion, debate, and an ocean of statistics, claims and counter-claims, the UK has voted to leave the EU and strike out on its own. It was always going to be a close-run thing, and even on the day of the referendum ...
 
Avita Taps JNJ Alumni For COO, Sales VP Roles Avita Medical, a specialist in regenerative medicine for wound and skin defect treatment, is expanding its executive management team as it grows ...
Vexim Scores Senior Exec Double Whammy Vexim, the French specialist in minimally invasive technologies for treating vertebral fractures, has made two new additions to its senior management ...
AirXpanders Installs New CFO/COO Scott Murcray has joined tissue expander specialist AirXpanders as chief financial officer/ chief operating officer, as the company is set to grow ...
14 June 2016
Ashley Yeo

The newly-issued English-language text of the EU Medical Device Regulation (MDR), as reported yesterday in Clinica, represents a good compromise that enhances patient safety in Europe. That was the initial reaction of German industry association ...

13 June 2016
Ashley Yeo

A summer lull has set in for the UK IVDs association, BIVDA , as far as ongoing projects for the diagnostics industry are concerned. But these are tense and even nervy times for EU IVDs businesses – and for UK-based companies in particular. BIVDA ...

 
24 June 2016
Corneal blindness affects an estimated 28 million people around the world yet a vast majority of cases are preventable, and almost all cases treatable through corneal transplants. One non-profit organization in India, the Tej Kohli Corneal Institute ...
 Series G Funding Takes EarlySense Deeper Into Digital...
14 June 2016
The newly-issued English-language text of the EU Medical Device Regulation (MDR), as reported yesterday in Clinica, represents a good compromise that enhances patient safety in Europe. That was the initial reaction of German industry association ...
13 June 2016
A summer lull has set in for the UK IVDs association, BIVDA , as far as ongoing projects for the diagnostics industry are concerned. But these are tense and even nervy times for EU IVDs businesses – and for UK-based companies in particular. BIVDA ...
22 October 2014
Amanda Maxwell

The future regulation of high-risk devices is one of the trickiest subjects in the proposed EU Medical Device Regulation (MDR) on which to reach final agreement, with the different parties involved seemingly at loggerheads. Delegates at the European ...

 
New clinical evaluation and vigilance transparency initiatives ahead of EU Regulations: helpful or scary?
22 September 2015
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21 March 2016
Ashley Yeo

European medical device and diagnostics manufacturers have adopted a new common Code of Ethical Business Practice which will be implemented nationally as of 2017. Industry sees the code as part of efforts to set visibly high ethical standards and as ...

 
17 June 2016

Specialty area(s): Cardiac rhythm managment Based in: Minneapolis, Minnesota, US Founded in: 2008 No. of employees: 5 Total investment received to date: $9.4m Investors: Cultivation Capital; Arch Angels; Broadview Ventures; BioGenerator; Belle ...

 
 
 
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