Medtronic plc teamed up with healthtech software company Modernizing Medicine Inc. (ModMed) to make colonoscopy procedures more efficient by integrating data generated from Medtronic’s GI Genius system into ModMed's gGastro EHR software to enhance endoscopic care.

The U.S. FDA’s final rule for lab-developed tests was a long time in coming even if the agency shorted the public comment period for the draft rule, and the final rule makes several major concessions about circumstances in which the agency would exercise enforcement discretion.

Imaging is the number one way physicians track cancer progression and burdens within neurology and cardiology, but the ability to take imaging information and interact with it to make better decisions is becoming ever more complicated.

In what represents its first patenting, Rhovica Neuroimaging AG seeks protection for an external ventricular drainage catheter for the drainage of cerebrospinal fluid to reduce intracranial pressure. The catheter is integrated with sensors which enable safe, fast and cost-efficient catheter placement and monitoring of brain ventricles.

Right on cue, the U.S. FDA’s Center for Drug Evaluation and Research (CDER) is scheduling its first in-person advisory committee meetings since the COVID-19 pandemic. Speaking during a May 6 webinar hosted by the Alliance for a Stronger FDA, CDER Director Patrizia Cavazzoni said the center was preparing to go back to in-person adcoms, adding that the first step likely would be a hybrid model.

The U.S. FDA finalized a guidance for third-party servicing of medical devices, which helps to clarify the distinction between servicing and remanufacturing of a device. However, the most significant change from the draft guidance is that the agency openly declared that it will inspect these independent services organizations, a dramatic shift from the agency’s previous formal stance on these entities.