Molli Surgical Inc. has won the FDA’s nod for its wire-free localization technology for breast cancer surgery. The company said the Molli system helps radiologists tag cancerous lesions quickly and precisely, facilitating surgical excision and eliminating a source of anxiety associated with breast tumor removal.
Onlume Inc. has secured $7 million in a series A round led by Cambridge Investment Group. Other investors participating in the round included WARF Ventures (Wisconsin Alumni Research Foundation) and Wisconsin Investment Partners. The proceeds will support the commercial launch of the company’s FDA-cleared fluorescence-guided surgery (FGS) imaging system.
Atricure Inc. has received the green light from the FDA for its Epi-Sense guided coagulation system with Visitrax technology to treat patients diagnosed with long-standing, persistent atrial fibrillation (AF). The device was previously cleared via a 510(k) for the coagulation of cardiac tissue, and is already available in the U.S. The FDA approval represents the first and only minimally invasive ablation therapy for the more than 3 million Americans with longstanding AF.
Keeping you up to date on recent developments in diagnostics, including: Urine test could reduce prostate cancer biopsies; Neurons forget who they are in Alzheimer’s disease; Sensor can predict hallucinogenic serotonin receptor effects.
Medtronic plc reported positive interim results on the first 171 patients implanted with Evolut transaortic valve replacement (TAVR) devices in its OPTIMIZE PRO clinical trial. The postmarket, prospective, multicenter study is assessing procedural outcomes, including pacemaker rate, associated with in-procedure techniques and post-procedure TAVR care pathways when using the self-expanding, supra-annular Evolut Pro and Pro+ TAVR systems in patients with symptomatic severe aortic stenosis.
The FDA has granted breakthrough device designation to Fractyl Laboratories Inc. for Revita DMR, a duodenal mucosal resurfacing treatment for patients with type 2 diabetes. The company recently launched the pivotal REVITA-T2Di clinical trial to evaluate the treatment in this population, in hopes it will offer a new option for people with the metabolic disease.
The FDA has granted de novo authorization to Neurolutions Inc. for its Ipsihand upper extremity rehabilitation system. The first-of-its kind device leverages robotics and brain-computer interface (BCI) technology to facilitate muscle training in patients with upper limb weakness or immobility following a stroke.
The FDA has approved Roche AG’s Ventana MMR Rxdx panel for patients with advanced or recurrent endometrial cancer. The companion diagnostic is the first to identify patients who are eligible for treatment with Glaxosmithkline plc’s (GSK’s) Jemperli (dostarlimab-gxly) monotherapy. The PD-1 antibody immunotherapy received FDA approval on Thursday.
Current Health Ltd. closed an oversubscribed series B financing, securing $43 million in a round led by Northpond Ventures. The Edinburgh, U.K.-based company will use the funds to scale up its remote care management platform. Other participants included Lrvhealth, OSF Healthcare, Section 32, Elements Health Ventures, as well as existing investors. With this latest infusion, Current Health has raised a total of $66 million to date.
Keeping you up to date on recent developments in diagnostics, including: AI-based model to triage brain MRIs; Tiny light probes enhance brain imaging; Predicting natural menopause age.
