Spotlight On... Cell-harvesting device to treat burns enters FDA's accelerated review pathway; FDA lines up panel on leadless pacemakers; Infosys invests $3M in Whoop wearable; and more...

Avita Medical's ReCell Autologous Cell Harvesting Device for treating burns became the latest entrant into the FDA's Expedited Access Pathway for accelerated approval of "breakthrough" devices. More specifically, the new program applies to devices that "demonstrate the potential to address unmet medical needs for life-threatening or irreversibly debilitating diseases or conditions." The designation was not issued by the FDA's device arm (CDRH), but by its Center for Biologics Evaluation and Research. CBER will now enter into further discussions with Avita on its data development plan. The U.K.-based company said it almost done with enrollment of its 30-patient clinical trial. Indeed, entrance into the EAP is designed to speed up FDA approval (or rejection) by enabling smaller clinical trials, among other advantages. In November, CVRx announced that its CE-marked Barostim neo neuromodulator to treat heart failure will be reviewed under the EAP. By FierceMedicalDevices' count, the number of devices in the EAP pipeline now stands at 6. Release

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