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RECENT TWEETS    
26 May 2016

 
26 May 2016
A deal may have been agreed on the future EU regulation of medical devices and IVDs, but it turns out that the European Commission is still unhappy about the chapter relating to reprocessing of single-use devices, among other things, and could use a ...
26 May 2016
The IVD industry will have a total of five years to comply with the EU’s new IVD Regulation after adoption. The IVD text, agreed by the Council of the EU and the European Parliament at the May 25 trilogue on the future IVD and medical device rules, ...
26 May 2016
Nearly eight years after it kicked off initial negotiations, the EU has finally agreed on how medical devices and IVDs will be regulated for the foreseeable future. These regulations will now set the framework for medtech design, clinical study, ...
25 May 2016
Mainstay Medical is ready to launch its ReActiv8 neurostimulator, starting in Germany, now that the implantable device has a CE mark for the treatment of chronic back pain, the company announced May 25. Mainstay has its own direct sales force that ...
 
26 May 2016
The IVD industry will have a total of five years to comply with the EU’s new IVD Regulation after adoption. The IVD text, agreed by the Council of the EU and the European Parliament at the May 25 trilogue on the future IVD and medical device rules, ...
25 May 2016
Angle is moving ahead with plans to take its Parsortix circulating tumor cell capture technology into the prostate and breast cancer diagnostic markets after securing £10.2m ($15m) in new capital through a share placement. The system is designed to ...
24 May 2016
Swedish firm Symcel has set its sights on the medical diagnostics field, in particular the area of antibiotic drug resistance, as part of a strategy to expand its calScreener calorimetric technology for cell-based assay beyond the current drug ...
24 May 2016
Boston Scientific is now going head-to-head with Medtronic in the MRI-compatible spinal cord stimulation market, having launched its Precision Montage MRI spinal cord stimulation (SCS) device. The US FDA approved the original Precision SCS in 2004. ...
 
25 May 2016
Angle is moving ahead with plans to take its Parsortix circulating tumor cell capture technology into the prostate and breast cancer diagnostic markets after securing £10.2m ($15m) in new capital through a share placement. The system is designed to ...
24 May 2016
Swedish firm Symcel has set its sights on the medical diagnostics field, in particular the area of antibiotic drug resistance, as part of a strategy to expand its calScreener calorimetric technology for cell-based assay beyond the current drug ...
23 May 2016
Sinclair Pharma has gained access to the world’s largest aesthetics market by enlisting Thermigen as the exclusive US distributor of Silhouette InstaLift, a non-surgical alternative to facelifts. Thermigen, the aesthetics subsidiary of pharma group ...
19 May 2016
ReCor Medical has enlisted Otsuka, a diversified healthcare group which houses one of Japan’s largest pharma companies, as the Asian commercialization partner for its Paradise ultrasound-based renal denervation system for treating ...
 
26 May 2016
A deal may have been agreed on the future EU regulation of medical devices and IVDs, but it turns out that the European Commission is still unhappy about the chapter relating to reprocessing of single-use devices, among other things, and could use a ...
26 May 2016
The IVD industry will have a total of five years to comply with the EU’s new IVD Regulation after adoption. The IVD text, agreed by the Council of the EU and the European Parliament at the May 25 trilogue on the future IVD and medical device rules, ...
26 May 2016
Nearly eight years after it kicked off initial negotiations, the EU has finally agreed on how medical devices and IVDs will be regulated for the foreseeable future. These regulations will now set the framework for medtech design, clinical study, ...
25 May 2016
As part of its planned overhaul of the regulatory framework for medicines and medical devices, the New Zealand government says it intends to 'realize New Zealand's potential as a clinical trial destination' by updating the clinical trial regulations ...
 
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 ...
23 May 2016
Ashley Yeo

As promised in mid-April, and just a month away from the UK’s yes/no vote on continued membership of the EU, the UK ABHI has completed and released a survey of its members’ views on this theme – its second within the past year. 32% of the ABHI’s ...

20 May 2016
Ashley Yeo

With less than five weeks to go to the UK’s referendum on EU membership, the medtech and IVD industries are finding their voices on an issue that will affect their economic futures in ways still not fully known. Maybe they never will be known, ...

 
23 May 2016
As promised in mid-April, and just a month away from the UK’s yes/no vote on continued membership of the EU, the UK ABHI has completed and released a survey of its members’ views on this theme – its second within the past year. 32% of the ABHI’s ...
 Brexit – Accentuate The Positive And Don’t Be Afraid To Voic...   Notified Body Staffing In New Tougher Era: Has It Risen Or F...
20 May 2016
Singapore set out to build a knowledge-based economy some 25 years ago and biomedical sciences have been a key focus of successive five-year R&D funding initiatives. In the first of a three-article series exploring Singapore’s R&D landscape – ...
20 May 2016
With less than five weeks to go to the UK’s referendum on EU membership, the medtech and IVD industries are finding their voices on an issue that will affect their economic futures in ways still not fully known. Maybe they never will be known, ...
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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