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The FDA granted AtheroMed’s Phoenix Atherectomy System 510(k) clearance to treat vessels below the knee in patients with peripheral artery disease. Read More
The FDA has issued draft guidance standardizing the way companies report computational modeling and simulation studies, paving the way for more computer modeling in medical device trials. Read More
The FDA does not review new clinical data in considering most cardiac implantable electronic devices, according to a study in last week’s Journal of the American Medical Association — a fact the authors say may have contributed to several high-profile recalls. Read More
The FDA’s new custom device exemption, granted under FDASIA, does not apply to 510(k)-cleared devices that are modified but still retain their original intended use and could be clinically studied, the agency clarifies in a draft guidance. Read More