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RECENT TWEETS    
06 May 2016

 
06 May 2016
There are a number of outstanding issues that still need to be resolved when it comes to EU decision-makers reaching agreement on the future IVD Regulation. But is there any truth in talk that this may now be delayed beyond the agreement date ...
06 May 2016
HeartWare is counting on the ENDURANCE II trial to earn the coveted destination therapy indication for its HVAD ventricular assist device, and help pull its sales and earnings out its current slump. HeartWare recorded a net loss of $72.8m for all of ...
06 May 2016
April was a slow month for medical device approvals, with just 46 recorded for the month on Clinica’s Medical Devices Approvals Tracker , but it was the biggest month for PMAs and PMA supplements approved by the US FDA in more than a year. The 46 ...
04 May 2016
The flow of VC deals continued to hold steady in April, with 22 transactions of $1m and over recorded last month and over $626m raised in total. While deal volume was almost comparable to a year ago, deal value was nearly triple that of April 2015. ...
 
03 May 2016
New data on the long-term clinical benefits of endovascular aortic repair (EVAR) have put the minimally invasive technique in a less than favorable light. However, these findings are not expected to dent the market for these devices as continued ...
29 April 2016
Clinica’s Clinical Corner provides an update on the latest R&D news and developments in ongoing clinical trials of early-, late-stage and approved medical devices. So-Far-So-Good For Endologix’ Nellix AAA EVAS Early results from the ASCEND ...
29 April 2016
In the third instalment of Clinica’s series on capital equipment purchasing trends in the National Health Service, Usman Goga and Victor Chua of Mansfield Advisors discuss the impact of ‘sweating the assets’ in medical imaging and implications on ...
29 April 2016
Alere confirmed analysts’ suspicions that Abbott Laboratories is reticent about its planned $5.8bn takeover of the embattled diagnostics company, but the deal appears to be back on track, for now. Abbott agreed to buy Alere in February for $56 per ...
 
04 May 2016
The flow of VC deals continued to hold steady in April, with 22 transactions of $1m and over recorded last month and over $626m raised in total. While deal volume was almost comparable to a year ago, deal value was nearly triple that of April 2015. ...
02 May 2016
Surgical and interventional robots have the potential to provide a level of precision and control beyond what is possible with conventional techniques. So far that potential is mostly untapped , but engineers and physicians from a variety of ...
29 April 2016
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) wants to charge an annual fee to manufacturers to pay for its market surveillance activities, but is expected to issue a 12-week public consultation first. The exact level of fee is ...
29 April 2016
Alere confirmed analysts’ suspicions that Abbott Laboratories is reticent about its planned $5.8bn takeover of the embattled diagnostics company, but the deal appears to be back on track, for now. Abbott agreed to buy Alere in February for $56 per ...
 
06 May 2016
There are a number of outstanding issues that still need to be resolved when it comes to EU decision-makers reaching agreement on the future IVD Regulation. But is there any truth in talk that this may now be delayed beyond the agreement date ...
04 May 2016
The use of nanomaterials and endocrine disruptors in medical devices are among the main work items for the European Commission’s Scientific Committee on Health Environmental and EmergingRisks (SCHEER) over the next five years, five year term ...
03 May 2016
The trilogue talks on the future EU Medical Device and IVD Regulations are now in the home stretch and two more discussions are due on May 11 and 25. With the final vote expected to go ahead on June 17, Clinica’s top ten stories of last month ...
29 April 2016
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) wants to charge an annual fee to manufacturers to pay for its market surveillance activities, but is expected to issue a 12-week public consultation first. The exact level of fee is ...
 
Autonomic Technologies Taps Thoratec Alumni For Leadership Roles Autonomic Technologies Inc., the developer of the CE-marked Pulsante microstimulator to treat cluster headaches, has appointed Niamh Pellegrini ...
New Leader At Elekta To Boost Bottom Line Cancer therapy specialist Elekta has appointed Richard Hausmann, a veteran in the medical imaging industry, president and CEO. Hausmann’s track ...
Philips Image Guided Therapy Unit Gets New CMO Philips has appointed Dr Atul Gupta as chief medical officer of its image guided therapy business. The unit sells imaging and measurement systems ...
04 May 2016
Tina Tan

Siemens Healthcare has now a new brand name, Siemens Healthineers, but the feedback so far indicates that people are less than impressed with the name change. Clinica conducted a quick Twitter poll following the German multinational’s announcement ...

02 May 2016
Ashley Yeo

After May 11, the next scheduled session of the EU trilogues, the EU diagnostics industry will have a better idea of whether the In Vitro Diagnostics Regulation (IVDR) in particular is progressing fast enough, or whether remedial action is ...

 
04 May 2016
Siemens Healthcare has now a new brand name, Siemens Healthineers, but the feedback so far indicates that people are less than impressed with the name change. Clinica conducted a quick Twitter poll following the German multinational’s announcement ...
 EU Commission’s Rebranded Scientific Committee Sets Out Five...   MNA ANALYSIS: Abbott Makes The Big Splash; Stryker Scores An...
02 May 2016
After May 11, the next scheduled session of the EU trilogues, the EU diagnostics industry will have a better idea of whether the In Vitro Diagnostics Regulation (IVDR) in particular is progressing fast enough, or whether remedial action is ...
28 April 2016
Stick to the evidence. Scientists tend to. It is claimed that this principle runs like a seam through the UK’s EU dealings on health issues, healthcare delivery and the healthcare products industry. Doubtless as it may in other EU nations, but none ...
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 April 2016

Specialty area(s): Non-invasive detection of postoperative ileus Based in: Memphis, Tennessee, US Founded in: 2012 No. of employees: 3 Total investment received to date: $800,000 Investors: Innova Memphis; Angel Syndicates Central; Angel Roundtable

 
 
 
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