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U.S. Docs Lead in Adopting Healthcare IT
United States is a leader in healthcare information technology use and adoption by physicians, and the penetration of healthcare IT is nearly equal among primary physicians and specialists, finds new study by Accenture.  
GAO Calls for Transparency in Device Pricing
A new survey found hospitals paying widely varying prices for the same implantable devices, and blamed confidentiality clauses in sales agreements for preventing buyers from getting the best deals. 
FDA Seeks $4.5 B for FY2013
Number indicates a 17 percent increase over FY2012 budget; industry user fees will fund 98 percent of increase.
Device-Diagnostic Industry to Touch $362 B by 2015
Technologies capable of facilitating changes in clinical pathways, lowering healthcare expenditure, eliminating non-essential diagnostic procedures, and enhancing accuracy of diagnostic procedures are expected to gain popularity in the medical equipment market, concludes new market research report. 
Sony: From PlayStations to Pacemakers?
The Japanese company, known for its TVs, games and music, is making acquisitions to bolster its medical business, foraying into medical imaging business, and setting up an innovation center to scout out new business opportunities.
Stryker CEO Departs Abruptly
Company attributed the departure to “family reasons” and offered no other details; sudden departure has some questioning future growth of the company. 
IRS Releases Guidance on Device Tax
The federal government details exemptions for medical device service providers and early-stage companies and addresses concerns around double taxation. 
ALung Gets $10M in Series B
New funding helps company further prepare to launch Hemolung , its artificial lung, in Germany this year. 
Rethink How You Operate, Accenture tells Medtech Cos.
While growth in the medical technology industry has slowed due to recession and other factors, the significant drop in the rate of growth in the medical technology industry is most concerning. 
FDA Approval for 2 St. Jude Catheters
St. Jude Medical wins pre-market approval for two of its next-generation cardiac ablation systems. 
Bio-coatings Stop Bleeding in Seconds
A team from MIT has designed a new biological dressing which has the potential to achieve almost an instant halt to bleeding, and can prove beneficial in reducing military and civil casualties.
Stryker Reveals New Products
Company celebrates "75 Years of Innovation" this year; reveals series of new products and services at the Orthopaedic Surgeons annual meeting this week. 
FDA Doubles User Fees; Promises Faster Reviews
Device makers agree to double the fees they pay to FDA, to $595 million, in turn for faster, more predictable review process. 
Medtronic Sells Physio-Control to Bain Capital for $478M
Bain Capital describes troubled Physio-Control business as a market leader at the forefront of emergency response technology.
France Health Authorities Call for Tougher EU Controls
Following the health scare involving substandard breast implants, French authorities are asking for ‘radically redrafting’ EU law relating to medical devices. 
Device Ombudsman Lists Complaints
The CDRH reports a 44 percent increase in complaints compared with 2010, and lists other contacts that the agency had with the public last year.
New Regulations Imminent in Russia
Russian authorities are expected to implement new medical device regulations concerning authorized representation, vigilance, country-of-origin approval and other issues within the next several weeks.
VCs Bullish about Medical Devices
The device industry surpasses, for the first time, the pharma industry in attracting VC funds.
Emerging Markets not for Small Players, Caution Med-tech Leaders
Emerging markets is necessary like 401(k) says one leader, while another cautions that smaller companies need to stay closer to home and leave such countries to those with resources to play the long game. 
Another Round of Bad News for J&J, DePuy Implants
FDA has sent a letter warning J&J /DePuy that several of their hip, knee and joint replacement devices were "improperly marketed." 
FDA Looking to Partner with Industry Groups
Agency announces working together with Biocom in an effort to speed up review process for devices; CDRH chief also calls for more collaboration in medical devices industry. 
FDA Misses Deadline
The U.S. Food and Drug Administration has missed a legal deadline to submit a proposal for Congressional approval over the cost of speeding up product reviews starting this year.
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Devine Guidance: IVDD Article 18 – Decisions in Respect of Refusal or Restriction
Article 18 does provide for an open channel, ensuring lines of communication exist between the 27-Member States, their Competent Authorities, the offending device manufacturer, and the device manufacturer’s European Authorized Representative.
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Pilgrim Software - Webinar - Safety Incident Management
Attend this webinar to discover how: Pilgrim’s Safety Incident Management capability helps companies record the incident, verify if the incident is reportable (such as on OSHA Form 301) perform investigations, manage actions and conduct follow ups, such as escalation to CAPA, in a consistent man...

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