Clinica    Scrip    Scrip Regulatory Affairs    Scrip Clinical Research    Animal Pharm   
Email ID
Password
Forgotten password?
Sign me in automatically next time
Home
Market Sector
Business
Policy & Regulation
Regions
News
|
Analysis
|
Features
|
MedTech Ventures
|
People
|
Events
|
Blog
|
Video & Podcasts
|
Science Abstracts
|
clinica
Medtronic's Q3 "in line", but hit by ongoing US ICD and spine weakness
22 February 2012
Two of Medtronic 's biggest units, implantable cardioverter defibrillator (ICD) and spine, continued to be hit, especially in the US, by challenging market conditions, resulting in sharp declines in sales of both products during its third fiscal ...
Australia explains regulatory requirements for in-house IVDs
21 February 2012
Australia's Therapeutic Goods Administration has issued its first ever guidance to help laboratories manufacturing in-house in vitro diagnostics comply regulations that were put in place on 1 July 2010, when the country adopted a new risk-based ...
Oxford Nanopore unveils disposable $900-genome sequencer; rival firms take a hit
20 February 2012
The race for the $1,000-genome is heating up, as UK firm Oxford Nanopore Technologies unveiled its contender, MinION, a disposable, single-use sequencer the size of a USB memory stick that will cost around $900. At the same time, the company ...
EU Commission says time to talk about interface with pharma on companion Dx
20 February 2012
The European Commission is proposing that there should be an exchange of views on the interface needed with the medicinal product legislation on companion diagnostics within the context of its discussions on the proposed revision of the IVD ...
 
Anvisa recreates Reblas path lab network, backed by new regulatory framework
22 February 2012
Brazilian healthcare products regulatory agency Anvisa has re-established the national pathology laboratories network, Reblas, and introduced a strengthened regulatory framework that will govern it. Reblas was first created in 1999, but was shut ...
Brazil begins consultation in review of breast implant standards
22 February 2012
Brazil, the world’s second-largest breast augmentation market, has begun a brief consultation on standards for breast implants. The focus of the consultation is to establish conformity assessment requirements specifically for these devices. The ...
Medtronic's Q3 "in line", but hit by ongoing US ICD and spine weakness
22 February 2012
Two of Medtronic 's biggest units, implantable cardioverter defibrillator (ICD) and spine, continued to be hit, especially in the US, by challenging market conditions, resulting in sharp declines in sales of both products during its third fiscal ...
Medtronic's Resolute Integrity enters US market with FDA greenlight
21 February 2012
The US drug-eluting stent market last week welcomed another new entrant, following the FDA premarket approval of Medtronic's Resolute Integrity DES. The company is already a key DES player with Endeavor, and Resolute Integrity is one of a wave of ...
 
Medtronic's Q3 "in line", but hit by ongoing US ICD and spine weakness
22 February 2012
Two of Medtronic 's biggest units, implantable cardioverter defibrillator (ICD) and spine, continued to be hit, especially in the US, by challenging market conditions, resulting in sharp declines in sales of both products during its third fiscal ...
Exec of scandal-ridden Olympus's Medical Systems unit commits suicide
21 February 2012
The managing director of Olympus Medical Systems in India, Tsutomi Omori , has been found hanged in a park in Delhi in an apparent suicide. The Olympus group, which specialises in medical equipment such as endoscopes and imaging equipment, as well ...
Greatbatch boosts neuromodulation offering with $12m NeuroNexus buy
20 February 2012
Implantable medical device firm Greatbatch has purchased neuroscience specialist NeuroNexus Technologies for $12m in cash, bolstering its offering in the neuromodulation segment. Ann Arbor, Michigan-based NeuroNexus develops and commercialises ...
Weak Q4 for Synthes rounds off a challenging 2011
20 February 2012
Synthes's fourth-quarter revenue grew by just 2% year-on-year, to $991.7m, weighed down by weakness in North America, where the company generates the biggest proportion of its revenue. Sales in this region declined 2%, at $539.3m, primarily due to ...
 
Anvisa recreates Reblas path lab network, backed by new regulatory framework
22 February 2012
Brazilian healthcare products regulatory agency Anvisa has re-established the national pathology laboratories network, Reblas, and introduced a strengthened regulatory framework that will govern it. Reblas was first created in 1999, but was shut ...
Brazil begins consultation in review of breast implant standards
22 February 2012
Brazil, the world’s second-largest breast augmentation market, has begun a brief consultation on standards for breast implants. The focus of the consultation is to establish conformity assessment requirements specifically for these devices. The ...
GHTF consults on draft guidance on clinical performance studies for IVDs
21 February 2012
The Global Harmonizaton Task Force is seeking feedback on a draft guideline that explains the factors that IVD manufacturers should consider when conducting clinical performance studies for their products. Clinical performance studies are designed ...
Australia explains regulatory requirements for in-house IVDs
21 February 2012
Australia's Therapeutic Goods Administration has issued its first ever guidance to help laboratories manufacturing in-house in vitro diagnostics comply regulations that were put in place on 1 July 2010, when the country adopted a new risk-based ...
 
PEOPLE
Jill Schiaparelli joins AxoGen as senior VP Regenerative medicine company AxoGen, which specialises in products and technologies for peripheral nerve reconstruction and regeneration, has ...
Duncan Whitney promoted to senior VP at Allegro Allegro Diagnostics , a molecular diagnostics company developing genomic tests for the diagnosis, staging and informed treatment of lung cancer and ...
Hospira names Zena Kaufman senior VP of quality Hospira , a leading provider of infusion technologies and injectable drugs, has appointed Zena Kaufman senior vice-president of quality, effective ...
>> More People News...
Lessons to learn from St Elsewhere on health systems under pressure
21 February 2012
Ashley Yeo

Lack of consensus still dogs England’s health and social care bill – please read on – as evidenced by yesterday’s Downing Street NHS meeting. Meanwhile, back in the real world, decisions have to be made as a matter of urgency. New Zealand is among ...

 
Lessons to learn from St Elsewhere on health systems under pressure
21 February 2012
Ashley Yeo

Lack of consensus still dogs England’s health and social care bill – please read on – as evidenced by yesterday’s Downing Street NHS meeting. Meanwhile, back in the real world, decisions have to be made as a matter of urgency. New Zealand is among ...

Companion diagnostics: reimbursement and regulatory issues high on EDMA agenda
20 February 2012
Amanda Maxwell

In the current climate of uncertainty surrounding companion diagnostics, the European Diagnostic Manufacturers Association, EDMA, is working hard to help its members address the regulatory and reimbursement challenges they are facing in this market, ...

EDMA at critical time of change: the revision, new federation and economic challenges
20 February 2012
Amanda Maxwell

The European Diagnostics Manufacturers Association is at a pivotal junction in its history. Intense discussions over the proposed revision of the IVD Directive are underway, EDMA's future management structure is undergoing a fundamental overhaul, ...

 
Companion diagnostics: reimbursement and regulatory issues high on EDMA agenda
20 February 2012
Amanda Maxwell

In the current climate of uncertainty surrounding companion diagnostics, the European Diagnostic Manufacturers Association, EDMA, is working hard to help its members address the regulatory and reimbursement challenges they are facing in this market, ...

 
VIDEOS/PODCASTS
Webinar replay: Successful US medtech strategies
14 April 2011
Get the Flash Player to see this player.
 

Advanced Therapies: is the EU regulatory approach putting a brake on market development?
19 January 2012
Amanda Maxwell

There is no doubt that the European Medicines Agency's Committee for Advanced Therapies (CAT) has put considerable effort into developing a significant number of guidelines to explain how it operates in the complex field of advanced therapy ...

 
The clinical diagnostics market – strategies for success
05 December 2011
Intelab Corp

The clinical diagnostics industry is evolving with the entry of a major new company from the medical device sector, emergence of a major new competitor in point-of-care (POC) diagnostics, an increasingly global level of competition, and differing ...

 
Clinica's MedTech Ventures: Issue 55
15 February 2012

This edition of Medtech Ventures highlights three UK companies, two focused on the diagnostics market, and the other on non invasive cancer treatment. Our hot pick, Lumora, hopes to make molecular diagnostics more affordable and accessible, with its ...

 
Organovo's bioprinter for new tissue and EStimME expands into middle ear drug delivery
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 ...

 
 
EVENTS
The 14th MedTech Investing Europe conference
19 March 2012
Montreux Convention and Music Centre, Switzerland
 
© 2012 Informa plc. All rights reserved.
This site is owned and operated by Informa plc ("Informa") whose registered office is Mortimer House, 37-41 Mortimer Street, London, W1T 3JH. Registered in England and Wales. Number 3099067. UK VAT Group: GB 365 4626 36
Home
Market Sector
Business
Policy & Regulation
Regions
Terms & Conditions
Privacy Policy
Sitemap
About Us
Advertise
Subscribe
Clinica
Scrip
Scrip Regulatory Affairs
Scrip Clinical Research
Animal Pharm