Pacira Cryotech Inc. reported the filing of a patent for a hand-held cryogenic treatment system with a probe configured to apply a cryogenic therapy to one or more nerves, such as the nerves of the stellate ganglion and autonomic tissue peripheral to the stellate ganglion.
The U.S. FDA’s concerns about the 510(k) program over the past decade-plus are practically the stuff of regulatory urban legend, but the agency has just unveiled a trio of draft guidances to address some of those concerns. Perhaps the most significant of these is a draft guidance for selection of a predicate device for a 510(k) filing, a document that may come across to industry as little more than an attempt to limit the devices that a manufacturer can recite in a 510(k) filing.
Abbott Laboratories took the next step in its years-long collaboration with Bigfoot Biomedical Inc. with the announcement after the market close on September 6 that it signed a definitive agreement to acquire the connected insulin cap maker. The financial terms of the transaction, which is expected to close this month, were not disclosed.
Neurochase Ltd. filed a patent for a septum-sealed transcutaneous, fluid-transferring device through which repeated access for the removal or delivery of fluid to the central nervous system (CNS) can be gained.
The U.S. FDA recently posted another round of recalls for the Cardiosave line of intra-aortic balloon pumps (IABPs) by Datascope Corp., advising users to make sure they have a backup unit at the ready in the case of device failure. However, the agency noted that “alternative treatments are limited,” a clear sign that this market lacks competition, most likely due to a lack of incentives for the private sector to invest in this class of devices.
The proposed U.S. Medicare framework titled Transitional Coverage for Emerging Technologies (TCET) promises to expand on existing mechanisms for Medicare device coverage, but industry has serious misgivings about the proposal.
When the data and safety monitoring board (DSMB) for Biocardia Inc.’s phase III pivotal trial of its Cardiamp cell therapy for heart failure advised pausing the study in July to analyze the interim results, the company expressed confusion as there were no reported treatment-emergent safety issues and aggregated blinded data showed better than expected outcomes. With the recommended external analysis now complete, the company confirmed the study is unlikely to achieve its primary endpoint at one year. The trial has now been unblinded.
Stimlabs LLC has taken a new view of wound healing by developing a fenestrated dehydrated complete human placental membrane allograft for chronic and acute wounds. The fenestration in the Release product allows fluids to drain away from the wound, promoting faster healing, while the tissue provides protection.
The pivotal ADVENT trial of the Farapulse pulsed field ablation (PFA) system developed by Boston Scientific Corp. returned positive results at one year, according to a presentation at the ESC Congress 2023 that was simultaneously published in the New England Journal of Medicine. The study compared Farapulse, a nonthermal treatment that ablates heart tissue, to radiofrequency or cryoablation, the current standards of care for paroxysmal atrial fibrillation.
Medtronic plc presented 10-year results from its ongoing trial comparing transcatheter aortic valve implantation with surgical aortic valve replacement. The results support use of the Medtronic Corevalve platform for lower risk of severe valve deterioration compared to surgical replacement.