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The FDA has requested a meeting with Express Diagnostics International, as well as an independent audit of the company’s manufacturing practices, following an inspection that uncovered problems with testing and labeling of the company’s products. Read More
Manufacturers of interventional cardiovascular devices may benefit from holding their first clinical trials in Europe, a clinical research organization advises. Read More
As more devicemakers branch into mobile medical apps, one common mistake they make is treating off-the-shelf hardware and software the same as hardware and software made in-house, an expert says. Read More
The Centers for Medicare & Medicaid Services’ launched its Open Payments database on Wednesday with no apparent technical problems, but industry concerns over the presentation of devicemaker payments to physicians and how the public will use the data were running high. Read More
SonaCare Medical’s hopes of marketing a new treatment for prostate cancer were dealt a setback Wednesday when an FDA advisory group recommended against approving the company’s Sonablate 450. Read More
The FDA on Thursday launched a new data dashboard, providing a more user-friendly way for manufacturers to obtain inspection and recall data. Read More
The FDA’s authority to reconsider and rescind earlier classification decisions could be severely limited following a recent federal court ruling. Read More
The FDA took another step toward assuming responsibility for the regulation of laboratory-developed tests with Friday’s publication of separate draft guidances on a proposed regulatory framework and medical device reporting requirements. Read More
The number of devicemakers receiving FDA warning letters following quality system inspections decreased 12 percent in 2013, compared with 2012 — the first decline since 2009. There were 144 warning letters with quality system regulation deficiencies in 2013, compared with 164 a year earlier. Read More
New rules from U.S. Treasury Department that reduce incentives for U.S. companies to incorporate overseas have thrown uncertainty into Medtronic’s planned merger with Ireland’s Covidien, and could make the deal less sweet. Read More