Manufacturers should use a two-step approach to grade nonconforming products — a matrix for determining the initial number, followed by escalations to set a final grade, according to a proposed guidance released last week by the Asian Harmonization Working Party. Read More

ITGI Medical and Vascular Solutions plan to begin enrolling patients in a humanitarian device exemption trial of ITGI’s Aneugraft Dx coronary stent during the first quarter of next year. Read More

Australia’s medtech field is growing rapidly, grossing roughly US $93 billion in 2012 and claiming a total of 41,292 devices on the Australian Register of Therapeutic Goods, a new industry report shows. Read More

The UK’s National Institute for Health and Care Excellence supports the use of Activa Healthcare’s Debrisoft pad for wound debridement in community clinics or at home, a draft guidance says. Read More

Johnson & Johnson is expected to pay more than $4 billion to settle lawsuits against the company over injuries attributed to Articular Surface Replacement (ASR) metal-on-metal hips made by its DePuy business unit, multiple news sources report. Read More

Physicians responding to a recent FDA survey reported good results with Intuitive Surgical’s da Vinci surgical system, but also highlighted a range of failures involving the robotic device. Read More

Medical devicemakers should be aware that they have become “lower-hanging fruit” for FDA enforcement of off-label promotion rules, and so have online product communications, two experts say. Read More

NeuroPace plans to launch its RNS Stimulator in the U.S. as soon as possible, following last week’s FDA approval of the novel anti-seizure device. Read More

If sequestration cuts continue into the 2014 fiscal year, CDRH will not be able to hire the review staff the agency promised to hire under MDUFA III, Director Jeffrey Shuren told Congress Friday. Read More

A federal court in California has ruled that using conventional diagnostic techniques in concert with a natural phenomenon does not add enough to make the end product patent-eligible. Read More

CDRH may prequalify scientifically validated tools to support the development and regulatory evaluation of new devices. Read More