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17 September 2014

 
17 September 2014
September marked the inaugural session of Clinica’s new monthly Access All Asia forum, which provides a platform for a core group of Asia-focused regulatory professionals to crosscheck intelligence regarding developments in the region, discuss ...
17 September 2014
Glenis Willmott, the UK MEP who lambasted the European Commission’s intention publicized last week to move oversight for medical devices and IVDs from its Directorate General health and consumer affairs to its DG responsible for industry, has been ...
16 September 2014
A three-month consultation on new South African proposals to establish general regulations relating to medical devices and in vitro diagnostic devices closed in mid-July, with industry hopeful that impetus has been newly injected into the long ...
15 September 2014
After several months of speculation, Danaher has agreed to buy number-two dental implant player Nobel Biocare for CHF17.10 ($18.27) per share. The all-cash deal is worth around $2.2bn, including assumed debt, and has been recommended by Nobel’s ...
 
16 September 2014
A group led by ex-Alere CEO Ron Zwanziger has made a move to buy the beleaguered company, for an estimated price of $3.82bn. Mr Zwanziger, who resigned unexpectedly from Alere in July , made a Schedule 13D filing with the US Securities and Exchange ...
16 September 2014
Medtronic has launched its first wearable heart monitor in the US, the short-term SEEQ mobile cardiac telemetry system. The 30-day monitor, used to help detect and diagnose the cause of irregular heartbeats in patients, was developed by Corventis, ...
15 September 2014
ReWalk Robotics has priced its initial public offering and started trading on the Nasdaq – but the total $36m raised fell short of its previous target. The firm initially said it wanted to pull in $57.5m; then reduced this target to around $51m. ...
15 September 2014
UK diagnostic specialist Immunodiagnostic Systems (IDS) has reduced its guidance, leading to at least one analyst reclassifying its stock as “sell.” The company is now expecting sales for the fiscal year ending March 2015 of £45-47m ($73-76m), ...
 
16 September 2014
A group led by ex-Alere CEO Ron Zwanziger has made a move to buy the beleaguered company, for an estimated price of $3.82bn. Mr Zwanziger, who resigned unexpectedly from Alere in July , made a Schedule 13D filing with the US Securities and Exchange ...
15 September 2014
ReWalk Robotics has priced its initial public offering and started trading on the Nasdaq – but the total $36m raised fell short of its previous target. The firm initially said it wanted to pull in $57.5m; then reduced this target to around $51m. ...
15 September 2014
UK diagnostic specialist Immunodiagnostic Systems (IDS) has reduced its guidance, leading to at least one analyst reclassifying its stock as “sell.” The company is now expecting sales for the fiscal year ending March 2015 of £45-47m ($73-76m), ...
15 September 2014
After several months of speculation, Danaher has agreed to buy number-two dental implant player Nobel Biocare for CHF17.10 ($18.27) per share. The all-cash deal is worth around $2.2bn, including assumed debt, and has been recommended by Nobel’s ...
 
17 September 2014
September marked the inaugural session of Clinica’s new monthly Access All Asia forum, which provides a platform for a core group of Asia-focused regulatory professionals to crosscheck intelligence regarding developments in the region, discuss ...
17 September 2014
A common market in medical device registration for the member countries of the new Eurasian Economic Union (EEU) is being discussed in a consultation posted by the Russian Federation on 3 September. Issued under the auspices of the World Trade ...
17 September 2014
Glenis Willmott, the UK MEP who lambasted the European Commission’s intention publicized last week to move oversight for medical devices and IVDs from its Directorate General health and consumer affairs to its DG responsible for industry, has been ...
16 September 2014
A three-month consultation on new South African proposals to establish general regulations relating to medical devices and in vitro diagnostic devices closed in mid-July, with industry hopeful that impetus has been newly injected into the long ...
 
Insulet bags veteran Patrick Sullivan as new CEO Insulin pump specialist Insulet has appointed Patrick Sullivan CEO, with long-time leader Duane DeSisto retiring after 13 years with the firm. ...
Ex-Acrobot CEO to head up Reapplix Privately-held Danish wound care specialist Reapplix has appointed Graeme Brookes CEO. Mr Brookes previously led robotic technology specialist ...
Hellebø replaces Hunt at the helm of stem cell firm ReNeuron UK stem cell specialist ReNeuron has appointed pharma veteran Olav Hellebø CEO with immediate effect. Mr Hellebø has experience at both large pharma ...
15 September 2014
Ashley Yeo

A blissful summer – albeit now swiftly receding – free of political sparring over the proposed twin EU medtech regulations? Or did you miss the duck and weave, the EU medtech industry being pummelled but still standing and coming out fighting again, ...

22 August 2014
Ashley Yeo

The case for a more concerted move towards adoption of digital pathology is stronger than ever. That is the impression left by Sara Dalmasso , GE Healthcare ’s UK-based general manager for digital pathology Europe, who says that the cost, accuracy ...

 
15 September 2014
A blissful summer – albeit now swiftly receding – free of political sparring over the proposed twin EU medtech regulations? Or did you miss the duck and weave, the EU medtech industry being pummelled but still standing and coming out fighting again, ...
11 September 2014
Jeroen Tas, CEO of Philips’ Healthcare Informatics Solutions and Services business, explains how big data could play an important role in the cardiology sector Healthcare is buzzing with the promise big data holds for both patients and clinicians. ...
08 September 2014
New measures to streamline and accelerate the US FDA approval process appear to be bearing fruit. Companies should now rethink their business strategy, write Ken West, Dennis Burns and Reinhard Merz of US consultancy TCG Defining a business ...
21 May 2014
Amanda Maxwell

There is a perceptible buzz these days around the subjects o fmHealth and healthcare apps. But how fast is the technology in these areas changing? How are the regulators going to police this market when it starts to really take off? Amanda Maxwell ...

 
“Beyond Compliance”: a self regulation tool to add strength to the CE marking – podcast
16 December 2013
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02 September 2014
Madeleine Armstrong

23andMe’s announcement earlier this month that it had teamed up with pharmaceutical firm Pfizer in inflammatory bowel disease (IBD) could pave the way for the expansion of personalized medicine into a new area. So far, the personalized approach has ...

 
11 September 2014

Specialty area(s): Motion management for radiation therapy Based in: London, UK Founded in: 2001 No. of employees: 54 Total investment received to date: £6.4m ($10.3m) Investors: Includes YFM Equity Partners

 
 
 
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