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20 August 2014

 
19 August 2014
BSI Group, one of the world’s largest notified bodies for medical devices, is planning to conduct up to 300 unannounced audits of medtech manufacturers globally this year. The move is part of its efforts to comply with new EU requirements designed ...
18 August 2014
The number of medtech acquisitions in 2014 looks set to overtake that in 2013, after M&A activity surged 24% in H1 compared with the same period last year. 2014 has also already seen the biggest ever deal in medtech, Medtronic’s agreed $42.9bn ...
18 August 2014
Australia's Therapeutic Goods Administration has signaled its distrust of the eight European medical device notified bodies whose business practices were questioned in a 2012 investigative study in the BMJ on the failings of the EU notified body ...
15 August 2014
Oraya Therapeutics is ramping up commercialization of its radiotherapy for age-related macular degeneration (AMD), a treatment that could disrupt a market currently dominated by drug giants Novartis and Roche with their anti-VEGF drug Lucentis. Even ...
 
19 August 2014
BSI Group, one of the world’s largest notified bodies for medical devices, is planning to conduct up to 300 unannounced audits of medtech manufacturers globally this year. The move is part of its efforts to comply with new EU requirements designed ...
18 August 2014
The number of medtech acquisitions in 2014 looks set to overtake that in 2013, after M&A activity surged 24% in H1 compared with the same period last year. 2014 has also already seen the biggest ever deal in medtech, Medtronic’s agreed $42.9bn ...
18 August 2014
Australia's Therapeutic Goods Administration has signaled its distrust of the eight European medical device notified bodies whose business practices were questioned in a 2012 investigative study in the BMJ on the failings of the EU notified body ...
15 August 2014
Further progress has been made by the International Medical Device Regulators Forum in the area of regulated product submissions (RPS) for medical devices and in vitro diagnostics. The IMDRF posted on its website on 14 August final documents ...
 
19 August 2014
Medtronic’s first-quarter results were an improvement over a mixed Q4 , beating analyst expectations – but only just. Q1 revenues of $4.27bn were up 5% year-on-year and edged above analyst predictions of $4.25bn; while non-GAAP earnings of $0.93 per ...
18 August 2014
The number of medtech acquisitions in 2014 looks set to overtake that in 2013, after M&A activity surged 24% in H1 compared with the same period last year. 2014 has also already seen the biggest ever deal in medtech, Medtronic’s agreed $42.9bn ...
15 August 2014
Oraya Therapeutics is ramping up commercialization of its radiotherapy for age-related macular degeneration (AMD), a treatment that could disrupt a market currently dominated by drug giants Novartis and Roche with their anti-VEGF drug Lucentis. Even ...
14 August 2014
Activity is heating up in the promising retinal implant space – the devices are designed to help restore vision in patients who have lost their sight. First, “bionic eye” developer Second Sight has priced its initial public offering, with a target ...
 
19 August 2014
BSI Group, one of the world’s largest notified bodies for medical devices, is planning to conduct up to 300 unannounced audits of medtech manufacturers globally this year. The move is part of its efforts to comply with new EU requirements designed ...
18 August 2014
Australia's Therapeutic Goods Administration has signaled its distrust of the eight European medical device notified bodies whose business practices were questioned in a 2012 investigative study in the BMJ on the failings of the EU notified body ...
15 August 2014
Further progress has been made by the International Medical Device Regulators Forum in the area of regulated product submissions (RPS) for medical devices and in vitro diagnostics. The IMDRF posted on its website on 14 August final documents ...
15 August 2014
The China Food and Drug Administration has issued for public comment a draft rule that bans the use of company names, brand names or trademarks the naming of medical devices in China. The “ naming regulation ” also prohibits the use of personal ...
 
Ex-Edwards exec Stefan Schreck becomes JenaValve CTO Not long after bagging a new CEO, German transcatheter aortic valve developer JenaValve has appointed Stefan Schreck chief technology officer. Dr ...
Former SNN exec to head up Rex Bionics Robotic exoskeleton developer Rex Bionics has appointed Crispin Simon CEO; when Mr Simon joins in October 2014, current chief Jeremy Curnock Cook ...
CryoLife makes Medtronic executive Mackin CEO CryoLife, which specializes in providing preserved human cardiac and vascular tissues for surgery, has appointed James Patrick (Pat) Mackin president ...
18 August 2014
Amanda Maxwell

News that the Australian Therapeutic Goods Administration is to re-audit all medical devices in Australia that were previously assessed by a group of eight specific notified bodies could represent a global challenge to the integrity of the current ...

12 August 2014
Ashley Yeo

The shift towards integration of telehealth systems and services in the US is happening at an increasing rate as providers see the benefits – and reap the rewards – of offering outcomes-based, rather than fee-for-service, piecemeal care. The ...

 
19 August 2014
Tina Tan

Google and Novartis’s eye care division Alcon hit the headlines last month when the two parties agreed to team up and develop a new generation of smart contact lenses – devices that will go beyond vision care to address unmet healthcare needs. As ...

18 August 2014
Amanda Maxwell

News that the Australian Therapeutic Goods Administration is to re-audit all medical devices in Australia that were previously assessed by a group of eight specific notified bodies could represent a global challenge to the integrity of the current ...

12 August 2014
Ashley Yeo

The shift towards integration of telehealth systems and services in the US is happening at an increasing rate as providers see the benefits – and reap the rewards – of offering outcomes-based, rather than fee-for-service, piecemeal care. The ...

 
19 August 2014
Tina Tan

Google and Novartis’s eye care division Alcon hit the headlines last month when the two parties agreed to team up and develop a new generation of smart contact lenses – devices that will go beyond vision care to address unmet healthcare needs. As ...

 
“Beyond Compliance”: a self regulation tool to add strength to the CE marking – podcast
16 December 2013
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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 ...

 
31 May 2012
Hua Gong

Cancer diagnostics provide a promising future for unraveling the mystery of one of the leading killer diseases and helping to better detect and treat it. However, companies are currently facing a number of potential challenges when developing cancer ...

 
05 August 2014

Specialty area(s): Alzheimer’s disease diagnostics Based in: Sacramento, California, US Founded in: 2010 No. of employees: 10 Total investment received to date: Around $4.5m Investors: Undisclosed

 
24 November 2011
Phil Greenfield

Clinica’s Patent Watch focuses on key growth areas of regenerative medicine, or where there is potential to selectively treat disease with drugs in personalised treatments, as is the case with emerging areas of drug delivery and molecular ...

 
 
 
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