The U.S. FDA cleared Paragonix Technologies Inc.’s Kidneyvault portable renal perfusion system, which combines digital monitoring capabilities and hypothermic perfusion technology to preserve donor kidneys during transportation.
Medtronic plc added a second U.S. FDA pulsed field ablation (PFA) device approval to its scorecard with the agency’s greenlight for its Affera mapping and ablation system with the Sphere-9 catheter. Affera brings the first radiofrequency/PFA device to the cardiac ablation market and ups the ante in the PFA competition.
Early results from REFLECTION, a real-world study, mirrored results for Grail Inc.'s multi-cancer early detection (MCED) assay in clinical trials, according to a presentation at the 2024 Early Detection of Cancer Conference. The study, conducted at U.S. Department of Veterans Affairs (VA) sites, focuses on the real-world application of the Galleri test, which screens for multiple cancers in asymptomatic individuals.
Boston Scientific Corp. posted another eye-popping quarterly report, led by a 177% year-over-year increase in its electrophysiology business to $527 million, which exceeded consensus expectations by $99 million. That stunning EP growth follows 125% growth in the second quarter and 70% in the first quarter, all largely attributed to the Farapulse pulsed field ablation system, which achieved unprecedented adoption rates.
Preliminary results from a trial demonstrated that Science Corp.’s Prima retina implant restored ‘form vision,’ including the ability to read in patients with vision loss. Originally developed at Stanford University and then advanced by Pixium Vision SA, Prima received U.S. FDA breakthrough device designation in April 2023.
Boston Scientific Corp. racked up a two-fer from the U.S. FDA with approval of its navigation-enabled Farawave Nav ablation catheter and 510(k) clearance for the Faraview software for use with its Farapulse pulsed field ablation (PFA) system.
Nowdiagnostics Inc. established an exclusive agreement with Labcorp Holdings Inc. for distribution of its First To Know syphilis test in the U.S. The test provides results in 15 minutes with as little as a single drop of blood. The test will be available to hospitals and clinicians by the end of 2024 and offered to patients directly through Labcorp Ondemand in 2025.
Medtronic plc received U.S. FDA approval to undertake an early feasibility study of its dual-energy Affera cardiac ablation system in sustained ventricular tachycardia. Affera combines both radiofrequency and pulsed field ablation technologies in the Sphere-9 catheter along with high-density mapping.
Novocure GmbH secured U.S. FDA approval for Optune Lua, a wearable device that delivers alternating electric fields or tumor treating fields that kill cancer cells. Indicated for use with PD-1/PD-L1 inhibitors or docetaxel in the second or subsequent line for the treatment of metastatic non-small-cell lung cancer following the failure of platinum-based regimens, the approval was driven by the significant improvement in overall survival rates seen in the LUNAR pivotal study for Optune Lua.
