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Manufacturers of passive implants, such as surgical screws, must begin subjecting products to magnetic resonance testing to see if they become dangerous when exposed to MR systems and radiofrequency heating, the FDA says. Read More
EU leaders are deadlocked over a proposed premarket mechanism for the highest-risk devices, and the stalemate threatens to delay adoption of a major overhaul in device and diagnostic regulations until late next year or even 2016. Read More
The Senate late Saturday approved a spending bill that gives the FDA just over $420 million in medical device and diagnostics regulatory funding, a slight drop from current levels. Read More
Stryker and its OtisMed subsidiary must ante up more than $80 million for distributing knee replacement surgery cutting guides that had been denied FDA clearance. Parent Stryker will also establish a compliance program to ensure all marketed products have the necessary approvals. Read More
A proposed rule that would narrow how hospitals interpret the term “reduce or limit services” under the anti-kickback statute and civil penalties rules could hurt patient care by denying access to medically necessary treatments, industry says. Read More
Members of the House health subcommittee are asking devicemakers to weigh in on key issues around the regulation of laboratory-developed tests, including whether traditional concepts of safety and effectiveness should be applied to LDTs, as they consider an appropriate legislative response. Read More
India’s drug pricing control bureau wrote to 10 multinational device companies earlier this month demanding pricing information on cardiac and drug-eluting stents, orthopedic implants and other notified products. Read More
An FDA decision to allow multiple entities to issue unique device identifiers could backfire and actually impede the uptake of UDI, medical device and healthcare industry experts warned last week. Read More
The FDA is ratcheting up safety controls on infusion pumps, mandating that developers of new pumps follow stricter requirements for design validation and verification and provide more detailed applications to address safety hazards associated with pumps used in the home. Read More
Hospira is recalling all of its GemStar Power Supply 3VDC units, used to power the GemStar Infusion Pump, because they may fail to deliver electric power to the pump. Read More
A sweeping rewrite of Canada’s drug safety law that authorizes the government to order recalls and require labeling changes and postmarket studies could spell new worries for devicemakers since it also allows for the release of confidential business information on unsafe products. Read More
The Brazilian government is providing more clarity around a voluntary program that encourages public-private partnerships to expand access to affordable medical devices and diagnostics, but questions remain about the program’s transparency. Read More