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The Justice Department has been going after “promoters” who fraudulently convince healthcare providers to bill the federal government for electro-acupuncture, or who market peri-auricular stimulation (P-Stim) devices using that as a selling point. Read More
The notified bodies that certify medical devices with a CE mark in the European Union are concerned that the EU may end up over-regulating the industry through its proposed regulation on artificial intelligence (AI). Read More
The annual internal audit can be considered the devicemaker’s front-line defense against 483 observations, warning letters and other enforcement actions. As such, it needs to be carefully designed, targeted to specific goals and fully supported by management. Read More
Scrambling to clear COVID-19 testing backlogs that have persisted all year, the Biden administration has disbursed more than $562 million to stimulate manufacturing and distribution of the kits over the next two years. Read More
ViaCyte’s implantable pouch filled with stem-cell-derived pancreatic cells is advancing in a first-in-human type 1 diabetes trial, showing clinically meaningful improvements in glycemic control and blood sugar, accompanied by a 70 percent decrease from the peak insulin dose. Read More
A bill that would replenish the national stockpile of devices and other medical products for use in national emergencies passed the House of Representatives with an overwhelming bipartisan majority of 397-22 last week. Read More
The FDA usually follows the advice of its advisory committees, but what that will mean in the case of Integra LifeSciences' SurgiMend for breast reconstruction is anybody’s guess, because the agency’s General and Plastic Surgery Devices Panel was deeply divided on the device’s safety and efficacy when it met last week. Read More