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31 July 2014

 
31 July 2014
The US FDA has finalized much-awaited guidance on how it determines that a medical device is "substantially equivalent" to a previous legally marketed device (also known as a predicate device) under its pre-market notification or 510(k) program. The ...
31 July 2014
Michael Alper of NeuvoMedica discusses the implications – good and bad – of the pending Medtronic and Covidien merger on the companies’ operations in China and on other players in that market One of the biggest news this year in the medical device ...
31 July 2014
Currently, most people with Type 1 diabetes are not diagnosed until the disease has already been progressing unchecked for some time. “Generally, you don’t know you have it until you have these more dramatic hyper- and hypo- uncontrolled glycemic ...
30 July 2014
Nearly two months has passed since the new Italian requirements for registering IVDs in the national Repertorio database of medical devices (RDM) came into effect in June but there is still much confusion among manufacturers. In particular, there is ...
 
31 July 2014
The US FDA has finalized much-awaited guidance on how it determines that a medical device is "substantially equivalent" to a previous legally marketed device (also known as a predicate device) under its pre-market notification or 510(k) program. The ...
31 July 2014
New Zealand's Medicines and Medical Devices Safety Authority (Medsafe) has updated its definitions for healthcare products in a move that will result in certain medicines being re-categorized as medical devices. The revised definitions, which ...
31 July 2014
Professor Karl Broich is to take over as chair of the German medicines and medical devices regulator BfArM effective 6 August. Professor Broich, who is currently vice-chair of the agency, succeeds Professor Walter Schwerdtfeger, who is retiring at ...
31 July 2014
Currently, most people with Type 1 diabetes are not diagnosed until the disease has already been progressing unchecked for some time. “Generally, you don’t know you have it until you have these more dramatic hyper- and hypo- uncontrolled glycemic ...
 
31 July 2014
Dental implant firm Nobel Biocare’s share price shot up earlier this week after rumors surfaced that it could be the next medtech company to be acquired. Although this “could be another attempt that leads nowhere, we believe this transaction is more ...
31 July 2014
Germany’s Siemens Healthcare has had another poor quarter, with sales falling 5% year-on-year to €3.19bn ($4.27bn), and profits shrinking 13%. The company blamed the declines on unfavorable foreign exchange rates; excluding these currency effects, ...
31 July 2014
Michael Alper of NeuvoMedica discusses the implications – good and bad – of the pending Medtronic and Covidien merger on the companies’ operations in China and on other players in that market One of the biggest news this year in the medical device ...
30 July 2014
Analysts are sweet on Edwards Lifesciences again, with Leerink Swann’s Danielle Antalffy describing its second quarter as “solid” and Jefferies’ Raj Denhoy dubbing it “high quality.” Overall, the firm’s sales jumped 11% year-on-year to $575.1m, ...
 
31 July 2014
The US FDA has finalized much-awaited guidance on how it determines that a medical device is "substantially equivalent" to a previous legally marketed device (also known as a predicate device) under its pre-market notification or 510(k) program. The ...
31 July 2014
New Zealand's Medicines and Medical Devices Safety Authority (Medsafe) has updated its definitions for healthcare products in a move that will result in certain medicines being re-categorized as medical devices. The revised definitions, which ...
31 July 2014
Professor Karl Broich is to take over as chair of the German medicines and medical devices regulator BfArM effective 6 August. Professor Broich, who is currently vice-chair of the agency, succeeds Professor Walter Schwerdtfeger, who is retiring at ...
30 July 2014
Nearly two months has passed since the new Italian requirements for registering IVDs in the national Repertorio database of medical devices (RDM) came into effect in June but there is still much confusion among manufacturers. In particular, there is ...
 
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 ...
Carlyle makes new appointments as it completes OCD buy Ortho-Clinical Diagnostics (OCD) officially transferred from Johnson & Johnson ownership to The Carlyle Group on 30 June, and Carlyle did not waste ...
Saccaro coming back to Baxter as spin-off plans gain pace James Saccaro will re-join Baxter International as chief financial officer, filling the vacancy left by current CFO Robert Hombach when he moves to ...
23 July 2014
Ashley Yeo

Mark Twain’s aphorism about lies and statistics was clearly on the mind of German Hospital Federation (DKG) chief executive Georg Baum yesterday after leafing through Barmer GEK’s 2014 hospital report . Barmer GEK, Germany’s largest substitute ...

21 July 2014
Ashley Yeo

Wales economy minister Edwina Hart was the toast of the life science business community in Cardiff last week as she cut the ribbon on the Life Sciences Hub Wales (LSHW). Overlooking Cardiff Bay, the hub is seen as the healthcare business forum for ...

 
23 July 2014
Mark Twain’s aphorism about lies and statistics was clearly on the mind of German Hospital Federation (DKG) chief executive Georg Baum yesterday after leafing through Barmer GEK’s 2014 hospital report . Barmer GEK, Germany’s largest substitute ...
 Stryker sells BMP products to Mariel...   REIMBURSEMENT UNRAVELLED: Germany’s new program for outpatie...
21 July 2014
Wales economy minister Edwina Hart was the toast of the life science business community in Cardiff last week as she cut the ribbon on the Life Sciences Hub Wales (LSHW). Overlooking Cardiff Bay, the hub is seen as the healthcare business forum for ...
15 July 2014
Obesity, adiposity, body fat percentage – a pet theme of the chattering classes and never out of the mainstream news for long, usually making an appearance only to confirm BMI trends showing we are all getting fatter. It ranks up there with global ...
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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09 July 2014
Madeleine Armstrong

Antimicrobial resistance (AMR) has been in the news recently, with UK Prime Minister David Cameron calling for “urgent action” in early July. But to fight AMR, a good test for infectious diseases (and potentially drug resistance) is also a must. ...

 
30 July 2014

Specialty area(s): Mobile health management Based in: Mountain View, California, US Founded in: 2010 No. of employees: Around 250 Total investment received to date: Undisclosed Investors: Sole backer is Andon Health

 
 
 
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