Chairman of the House Energy and Commerce Health Subcommittee, Rep. Joe Pitts (R-PA) wrote an insightful editorial this weekend about the FDA’s impact on American inventiveness and medical innovation. Read More
A recent report from the Competitive Enterprise Institute found the FDA is overly burdensome for manufacturers when it comes to the Agency’s review of medical devices. Read More
Yesterday, President Obama unveiled his plan to jumpstart the economy and get Americans back to work. However, he missed an opportunity to highlight an industry that is vital to that goal. 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
Earlier this week Senators Al Franken (D-MN) and Scott Brown (R-MA) criticized the U.S. Food and Drug Administration (FDA). Read More
As discussed in yesterday’s blog, members of Congress from both sides of the aisle are concerned that medical device review processes in the U.S. may lead companies to market innovative technologies in other countries before selling their products here at home. 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
Today and tomorrow, Congress is holding hearings on the FDA’s processes to clear and approve medical devices. 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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