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 However, the most significant change from the draft guidance is that the agency openly declared that it will inspect these independent services organizations, a dramatic shift from the agency’s previous formal stance on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. Read More
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. Read More
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. Read More
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. Read More
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. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Arecor, Biolabs, Danaher, Edwards, Elekta, Medtronic, Philips, Pulse Biosciences, Reflow Medical, Sam Medical, Samsung Medison, Sonio, Tri-Tech Forensics, Volta Medical, Watmind. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biogennix, Freyja, Othofix, Orthoxel, Terumo. Read More
The recent cyberattack on Change Healthcare, a part of the Unitedhealth Group, crippled reimbursement claims processing for thousands of providers for several weeks and potentially exposed troves of patient data. Congressional committees are investigating the attack, its scope, and Unitedhealth’s response. Please take a few minutes to fill out this short survey to help BioWorld understand how your company is responding to these threats. You can click through to the questions here. Read More
