This article was originally published in The Gray Sheet
Innovasive Devices: Company debuts its BioRoc bioabsorbable suture anchor for reattaching soft tissue structures back to bone. The device is "the first active, expandable bioabsorbable suture anchor" on the U.S. market, Innovasive maintains...
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A new European Commission guidance document explains the regulatory basics and much- altered emergency market entry criteria for new entrants to devices sector amid the COVID-19 crisis.
The race is now on to get formal adoption of European Commission proposal postponing the MDR by one year and allowing more devices on the market more quickly. But potential hurdles are in the way as experts advise caution.