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 However, the most significant change from the draft guidance is that the agency openly declared that it will inspect these independent services organizations, a dramatic shift from the agency’s previous formal stance on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.

Field Medical Inc. kicked off its first-in-human study for its Fieldforce ablation system, designed for use in ventricular arrhythmias. The Ventricular Catheter Ablation Study study will enroll 60 patients in five centers around the world, most recently kicking off in the Na Homolce Hospital in Prague, Czech Republic.

Researchers have developed a method to repair nerve connections in patients with spinal cord injuries using red and near-infrared light. The team from the University of Birmingham, U.K., are now planning to develop an implantable device to help surgeons protect and repair the spinal cord.

The latest patent filing from Cranius LLC describes a reservoir for its implanted drug delivery devices which is shaped and formed to empty and fill reliably without any concern for neighboring organ impingement or compression, and which can precisely control and monitor exactly just how much of a medicine is being delivered.