Canary Medical Inc. is seeking patent protection for devices, systems, and methods for in vivo monitoring of the flow of a biological fluid in an anatomic structure.
Cordis Corp. covered its bets a bit as it closed the acquisition of M.A. Med Alliance SA (Medalliance) announced almost a year ago. While the total payment for the company could total $1.135 billion, it could take six years for the owners of privately held Medalliance to see most of the funds.
After a long and bumpy path to approval, the U.S. FDA has finally given the green light to Cyclopharm Ltd’s Technegas combination product a day after the Sept. 29 PDUFA date.
At its Investor Day on September 20, Boston Scientific Corp. unveiled an ambitious long-range plan to become “the highest performing med-tech large-cap company” in terms of financial performance, sales growth, EPS, execution and talent retention.” That’s a notable step up from its 2021 goal of being just one of the top performers.
The annual volume of implant of transcatheter aortic valve replacement (TAVR) devices has grown steadily over the years, and that volume might sustain its upward trajectory over the next few years if the results of a new analysis of more than 46,000 TAVR patients gain traction. The data for these patients with minimally symptomatic aortic stenosis (AS) predictably indicated that this group was less susceptible to bad outcomes than those with more severe symptoms, but one of the hopes is that earlier intervention into AS could ward off future cardiovascular events, a finding which might justify expanded payer coverage for TAVR in these patient populations.
Gradient Denervation Technologies SAS closed a €14 million (US$15 million) series A financing round that will help the company with the ongoing clinical development and evaluation of its ultrasound-based catheter device to treat pulmonary hypertension. The financing round was led by Asabys Partners, with participation from Thuja Capital and founding investor Sofinnova Partners.
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.
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.
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.
Four months after raising $55 million, Magenta Medical Ltd. reported the completion of enrollment to a U.S. FDA-approved early feasibility study with the Elevate percutaneous left ventricular assist device (pLVAD).
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