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BioWorld - Saturday, May 2, 2026
Home » Topics » Medical technology

Medical technology
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Court report: Jury returns favorable verdict for Retractable Technologies vs. BD

Sep. 23, 2013

FDA advisory committee: ReSure vote yields five 'ayes', but IFU fix may win the day

Sep. 23, 2013
By Mark McCarty

Healthcare survey finds 88% will pursue M&A next year

Sep. 23, 2013
By Amanda Pedersen

Washington roundup: FDA yields on inventory issues, implants in UDI final guidance

Sep. 23, 2013
By Mark McCarty
FDA has issued the final guidance dealing with unique device identifiers (UDIs) and has made allowances for UDIs on implant devices and for inventory manufactured prior to the date of compliance. Two industry associations applauded the agency for making adjustments for the concerns expressed by device makers, although both indicated in formal statements that they are withholding judgment pending a more extensive review. One point FDA did not bend on was the timeline for compliance, although the agency indicated it would flex on the one-year deadline for class III devices in some cases.
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Washington roundup: ReSure hits efficacy endpoint; protocol deviations a problem

Sep. 20, 2013
By Mark McCarty

Financings roundup: Infraredx gets $25M TVC imagingsystem investment from Nipro

Sep. 20, 2013

Agreements/contracts: Ventana collaborates with Boehringer for diagnostics

Sep. 20, 2013

Restructuring roundup: Citing ACA, Cleveland Clinic to cut $300M, warns of layoffs

Sep. 20, 2013

Court report: Alleged secret deal finds Boston Sci facing hefty suit

Sep. 20, 2013

HIT roundup: Bruker unveils ParaVision 6 preclinical MRI software

Sep. 20, 2013
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