Israeli startup Synchrony Medical Ltd. is gearing up to begin a U.S. clinical trial testing an airway clearance method developed at Israel’s Sheba Medical Center. The Libairty device is designed to support chronic lung disease patients to clear mucus with a short home-based daily treatment.
Immunovia AB is progressing a study evaluating its Immray Pancan-d blood test for the early detection of pancreatic cancer in patients with new onset type 2 diabetes. Studies have found that type 2 diabetes is a major risk factor for developing pancreatic cancer, and the screening of molecular biomarkers may help patients access treatment before they develop symptoms. The company’s lab-developed test (LDT) measures nine serum biomarkers that, when combined in an algorithm, can detect pancreatic ductal adenocarcinoma.
After three years of clinical research, Royal Philips NV said its Tack (4-F) endovascular system has shown promising results for arterial dissection repair following balloon angioplasty in patients with critical limb ischemia and infrapopliteal arterial occlusive disease. The data was collected from a 36-month follow-up in the Tack Optimized Balloon Angioplasty (TOBA) II below-the-knee clinical trial.
A new large-scale study has found combining artificial intelligence (AI) and radiologists to analyze breast cancer screenings can lead to better patient outcomes, when compared with unaided radiologists and the use of AI alone. The study, published in The Lancet Digital Health, evaluated the performance of an AI decision referral system developed by Vara (MX Healthcare GmbH).
With top line results from its major phase III RECON study in hand, Axogen Inc. is hoping to expand adoption of its allograft nerve repair product Avance. RECON was designed as a non-inferiority study comparing Avance to nerve cuffs (manufactured conduits) which are commercially available. The study met its primary endpoint for the return of sensory function as measured by static two-point discrimination, and the safety profile was consistent with previously published data.
Regenerative medicine company Orthocell Ltd. reported final data from its nerve reconstruction study that showed patients continued to improve between 12- and 24-months post-treatment with regenerative nerve repair device Remplir.
Penumbra Inc. presented new data at the LINC Symposium in Leipzig, Germany, evaluating its Indigo aspiration system for submassive pulmonary embolism (PE). The subgroup analysis evaluated performance outcomes of patients with main pulmonary artery (PA) emboli vs. discrete unilateral or bilateral PA emboli without main PA involvement. Data from the study suggests the system can be used effectively for both proximal and distal aspiration thrombectomy in the pulmonary arteries.
Sophia Genetics SA shared preliminary findings from its multimodal Deep-Lung-IV clinical study at the 2022 American Society of Clinical Oncology annual meeting. The study is utilizing Sophia’s cloud-based, artificial intelligence diagnostic platform to identify multimodal predictive signatures of response to immunotherapy for patients with advanced lung cancer.
Several companies showed promising results for automated insulin delivery (AID) systems at the American Diabetes Association (ADA) annual meeting in New Orleans. Studies of the systems, also known as artificial pancreas systems, indicate that integration with continuous glucose monitoring (CGM) systems enables substantially improved glycemic control, with more time in range (TIR) and less hypoglycemia than seen with multiple daily injection (MDI) therapy or insulin-pump therapy.
Endotronix Inc. reported positive data from the SIRONA 2 clinical trial evaluating safety and efficacy of its Cordella pulmonary artery pressure sensor system in New York Heart Association (NYHA) class III heart failure (HF) patients.
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