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Medtech companies could see an increase in hostile takeover attempts and other forms of mergers during the remainder of 2014, as M&A activity heats up and companies look to complete product portfolios, a new report by Pricewaterhouse Coopers concludes. The group offers some advice for companies facing corporate change. Read More
Two years after the FDA proposed using device registries as tool to strengthen postmarket surveillance, some healthcare groups are saying the agency has not done enough to make that happen. Read More
The FDA has warned Winter Park, Fla., devicemaker Iradimed for failing to initiate and validate corrective actions related to its infusion pumps and sets. Read More
Devicemakers are urging the Centers for Medicare & Medicaid Services to maintain the current exemption on reporting financial support for continuing medical education programs under the Physician Payment Sunshine Act, a policy threatened by a proposed rule. Read More
With FDA investigators soon to begin scrutinizing UDI compliance, Class III devicemakers should prepare by ensuring that UDI changes in design history files are adequately documented and that the company has a verification process for barcodes in place. Read More
The FDA has warned Vention Medical’s Barreal de Heredia, Costa Rica, facility over environmental controls, equipment upkeep and other quality issues. Read More