Synchrony Medical Ltd. received the greenlight from the U.S. FDA for its Libairty airway clearance system which is expected to transform the lives of people with chronic lung diseases. The company is now looking to raise $5 million in series A funding to support the launch of the product in the U.S. later this year.

The U.S. FDA recently posted three alerts under the agency’s early alert program, including an alert for the V6 and V8 versions of the Sigma Spectrum infusion pumps by Baxter International Inc., which was the result of a mix-up in software installation.

Cochlear Ltd. heard good news from the U.S. FDA, as the agency approved its next-generation cochlear implant, the Nucleus Nexa System, the first smart cochlear implant system. Cochlear expects to launch the new products in the U.S. in the next few months, Brendan Murray, vice president for Cochlear Implant products portfolio and strategy told BioWorld.

The next FDA device user fee agreement is formally in negotiations but a recent agency report shows device makers are increasingly keen to interact with FDA reviewers. This is a fact that may make it difficult to keep the next user fee schedule from increasing dramatically over the current agreement.

The U.S. FDA noted in a series of Federal Register declarations that several device makers are working with the Patent and Trademark Office to claim regulatory review times for their devices, including the Sapien 3 Ultra Resilia device by Edwards Lifesciences Corp.

Insightec Ltd. received U.S. FDA approval for use of its Exablate Neuro device to address severe motor symptoms in patients with Parkinson’s disease, offering a new option for patients who have not found adequate relief from medications. Exablate Neuro uses focused ultrasound to create lesions in the brain without requiring an incision or implant.

Boston Scientific Corp. gained a second U.S. FDA approval for its Farapulse pulsed field ablation catheter, expanding its use into drug-refractory, symptomatic persistent atrial fibrillation (AF) in addition to its existing approval for paroxysmal AF. The expanded indication marks the first of several regulatory approvals the company expects in the coming months.

Without using the words “universal” or “nationwide,” a U.S. district judge granted a preliminary injunction July 1 to stop the Department of Health and Human Services’ (HHS) reorganization plan, along with any workforce reduction that’s part of the plan.

Could the U.S. FDA’s de novo marketing authorization for Tissium SA’s Coaptium Connect, an atraumatic sutureless solution for peripheral nerve repair, signal a transformative shift away from sutures in nerve surgery? Only time will tell.

The U.S. FDA finalized the latest edition of its premarket cybersecurity guidance, but the agency is of the view that any device with software is subject to the terms of the guidance even though the statute would seem to exempt device software that lacks connectivity.