More and more doctors use tablets and smartphones to help treat their patients. The FDA has already cleared several diagnostic imaging apps for use, and more are likely as prevalence for these devices in clinical settings continues to rise. Read More
Medical device manufacturers have expressed concerns that frequent turnover at the FDA’s Center for Devices and Radiological Health (CDRH) negatively impacts the submission of innovative, life-saving technologies. Read More
Today, the House Energy and Commerce oversight subcommittee held a hearing to discuss regulatory reform in the medical device industry. Read More
Co-Chairman of the bipartisan House Medical Technology Caucus, Representative Erik Paulsen (R-MN) announced last week that he is drafting a bill to streamline the approval and clearance processes for medical devices. Read More
In a recent study, researchers from Northwestern University found that “two-thirds of small medical device companies engaged in developing new products are obtaining approvals in Europe first.” Read More
On February 17th, the House Energy and Commerce Committee’s Health Subcommittee held a hearing on the impact of medical device regulation on jobs and patients. Read More
Yesterday, FDA’s Center for Devices and Radiologic Health announced their “Innovation Initiative” which seems designed to provide a pathway for advanced medical technologies to reach the market. Read More
MITA released a report yesterday detailing the troubling impact of insurance coverage denials on patient access to medical imaging procedures. Data gathered by the Patient Advocacy Foundation (PAF) show that denials for patients seeking potentially life-saving medical imaging services have doubled in the past four years. Of even greater concern is the finding that 90 percent of the reversed denials for imaging services were actually covered by patients’ health plans. And on average, PAF’s professional case managers required 15.4 contacts per patient case to resolve the imaging issue, meaning it took on average more than 15 phone calls, letters or emails to determine why the imaging test was being denied coverage. Read More
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- CDRH
- FDA
- Innovation
- iPad
- iPhone
- Smartphones
- Tablets
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