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The FDA has asked Spacelabs Healthcare, a maker of patient monitoring devices, to get an audit from an outside consultant to address problems with corrective and preventive actions and MDRs. Read More
Manufacturers implementing unique device identification may choose a barcode for their Automatic Identification Data Capture technology, or they can use “any other technology that serves the same objectives,” new FDA guidance clarifies. Read More
Medtronic has possibly “the deepest pipeline in company history,” setting it up to weather recent marketshare losses and boost growth in the second half of the year, Leerink Swann analyst Danielle Antalffy says. Read More
Sponsors of device clinical trials should carefully examine the demographic distribution of study participants at various points during the study, the FDA says in final guidance published Wednesday. Read More
A former FDA employee plans to press forward with efforts to remove Lasik eye surgery devices from the market following the agency’s denial of his citizen petition seeking the ban. Read More
Implantable heart devices improve the chances of survival across racial groups, a study published in Tuesday’s Journal of the American College of Cardiologists concludes. Read More
The FDA has released a three-point action plan aimed at encouraging more diverse patient participation in medical device and drug clinical trials. Read More
The Centers for Medicare & Medicaid Services will launch its Sunshine Act open payments database on schedule next month, but about a third of submitted data won’t be posted, the agency said Aug. 19. Read More
The Internal Revenue Service may soon begin sending reminder notices to devicemakers it suspects of failing to pay the new 2.3 percent medical device excise tax after the agency found revenues from the tax fell more than $250 million short of expectations in the first half of 2013. Read More
Citing industry concerns, the FDA has reversed plans for a proposed voluntary presubmission process that would have allowed sponsors to get reviewer feedback before submitting an investigational device exemption application. Read More
The deal leverages existing vascular technologies and customer relationships to drive increased market penetration, the Irish devicemaker says. Read More