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The device industry is asking the FDA not to impose controls, including quality system regulations, on manufacturers of low-risk health information management software that doesn’t serve a clinical function. Read More
Manufacturers of some types of durable medical equipment could see their Medicare and Medicaid reimbursement rates cut by more than a third if a proposed rule to expand the government’s DMEPOS competitive bidding program nationally takes effect. Read More
Patient groups and FDA advisory panel members sparred over whether a controversial treatment for uterine fibroids should be removed from the market, with the former claiming that power morcellators pose a serious health risk and some panelists saying the risks have been overstated. Read More
Cooper Companies stands to expand its foothold in the daily disposable contact lens market with its purchase of Sauflon Pharmaceuticals, analysts say. Read More
Devicemakers could spare themselves time and money by checking with UDI-issuing agencies to see if they have a current account before applying for new licenses, a former FDA official says. Read More