Washington roundup: FDA proposes to reclassify two class III catheter types
FDA will probably never get any credit for being the fastest-responding of all federal agencies, and the announcement yesterday that it will reclassify some coronary artery catheters from class III to class II did nothing to dispel doubts about the agency's responsiveness to advisory panel recommendations. (Medical Device Daily)
Medical Device Daily State of the Industry Report 2010
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Cake and eat it: why FDA should regulate gene testing
The question of whether FDA should regulate gene testing services offered to establish a customer's propensity toward a disease state has been bubbling for a couple of years, and the agency recently concluded that such tests are indeed diagnostic devices. As readers of Medical Device Daily know, this view has support from Capitol Hill, as demonstrated by a recent hearing in a House Energy and Commerce subcommittee (Medical Device Daily, June 23, 2010). (MDD Perspectives)
Judy Rosenbloom: Her Firm Focuses on Reimbursement Issues
Judy Rosenbloom is the founder and president of JR Associates, a Los Angeles-based medical device reimbursement consulting company. JR Associates specializes in strategic coding, coverage and payment solutions for device manufacturers, venture capital firms and healthcare practitioners. (Biomedical Business & Technology)
