News
Imaging Market: M&As Likely to Further Strengthen Power Players
Companies are likely to turn toward mergers and acquisitions (M&As) over the next four years to overcome the negative effects of the economic recession. According to a report from Frost & Sullivan, “Consolidation/M&A in Medical Imaging Market,” “...
A Stricter 510(k) Process Offers Challenges, Promises
FDA has released its long-awaited plans to shore up the 510(k) clearance system used to get many medical devices to market. In August, the agency published a 120-page report to define which devices are appropriate for the approval pathway and when those applications would require...
Frost & Sullivan Honors Siemens for CT Technology
Frost & Sullivan has awarded Siemens Healthcare its 2010 North American Frost & Sullivan Award for Technology Leadership of the Year in the computed tomography (CT) imaging market. The award was based on industry analysis and cited Siemens’s long history in dose-...
User Fee Rates Announced
Table I. Medical device user fees for FY 2011. FDA has announced the user fee rates for FY 2011. Federal law stipulates that the fee rate for each submission type is set at a specified percentage of the standard fee for a premarket approval (PMA) application. For FY 2011,...
Highlights of Proposed Changes to 510(k)
Some of the important changes proposed by FDA’s report include the following:   Introduction of Class IIb Devices. These devices, which may include implantable or life-sustaining devices, would usually require the submission of clinical data and manufacturing data in the...
Ohio a Rapidly Growing Hub for Device Innovation
Although Minnesota, California, and Massachusetts have long been recognized as major centers for medical device manufacturing, Ohio is quickly gaining steam as a global player in the industry. The state is home to more than 300 medical device companies and the University of Ohio...
Memry: The Virtues of Vertical Integration
Memry produces nitinol using a vertical integration approach. You don’t hear many companies bragging about their vertically integrated operations. In fact, the concept has fallen out of favor, as evidenced by firms rushing to outsource all but their core business...
Do Unproven CAD Tools Get the Benefit of Reimbursement?
Although not ubiquitous, computer-aided detection is widely used in mammography. A recent study has found that as long as doctors can get reimbursed for new medical technology, the technology does not have to show clear-cut benefits for them to use it. The findings,...
Investment in Industry Is Leaner, but Still Alluring
The recession hasn’t scared investors away from the medical device industry. Although it has certainly felt the effects of recent economic conditions, the device industry has proven itself to be fairly resilient through the downturn, according to Anthony Storino, senior...
Government Gets Competitive with Tax Credit
This fall, the government will award $1 billion in tax credits and cash grants to companies that develop new therapies. The goal of the program is to support research that has the potential to create new therapies as well as generate high-quality, high-paying jobs in the United...