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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
The FDA has warned Smith & Nephew for failing to report a recall of the Renasys soft port dressing, used with its Renasys line of negative pressure wound treatment devices. Read More
A group of Senate Democrats is pressing the Office of Management and Budget to release long-promised draft guidance on laboratory-developed diagnostic tests. Read More
Over the next four years, the FDA plans to increasingly coordinate its inspections and enforcement activities with its international counterparts. Read More
The Department of Commerce plans to submit a list of all known conflict mineral processing facilities to Congress by Sept. 1, according to a new report from the Government Accountability Office. Read More
Venture capitalists interested in the mobile health sector may want to take a closer look at clinical app investments, a recent report by Boston-based Lux Research suggests. Read More
The government should provide grants for public-private partnerships working to advance new medical technologies, William Murray, president and CEO of the Medical Device Industry Consortium, told lawmakers Wednesday. Read More