Insulet Corp. reported positive results from a pivotal trial of its Omnipod 5 automated insulin delivery system for patients with type 1 diabetes. The tubeless, wearable insulin delivery system lowered hemoglobin A1c (HbA1c) – a critical diabetes measure – in children, adolescents, and adults, and improved the time that patients were in the target blood glucose range. The data was presented at ENDO 2021, the Endocrine Society’s annual meeting, which was held virtually this year.
TORONTO – Hemocath Ltd. is gearing up for a first-in-human trial of a device that addresses two critical metrics for the treatment of heart failure: pulmonary artery and central venous pressure. Hemocath’s pulmonary artery catheter (PAC) is part of a larger heart failure monitoring platform and is intended to assess fluid status in patients with severe or worsening congestive heart failure. The hope is to replace larger, more invasive catheters inserted into a patient’s neck.
Advanced Oncotherapy plc reported new findings demonstrating the potential ability and superiority of its next-generation proton therapy system, LIGHT, to treat resistant cancers. The findings build on research at the Mayo Clinic that highlighted the benefits of combining proton therapy (PT) with targeted small molecule damage repair inhibitors.
LONDON – New research shows it is possible to diagnose Parkinson’s disease by mass spectrometry analysis of sebum samples taken with a simple skin swab, and that the same technique has potential to be used for diagnosing COVID-19. In a paper published in Nature Communications on March 11, 2021, scientists and clinicians in the U.K. and the Netherlands describe using high resolution mass spectrometry to profile the chemical signature of lipids and other biomarkers in sebum from Parkinson’s patients and show how these exhibit subtle but fundamental changes as the disease progresses.
Histosonics Inc. is testing its investigational histotripsy technology to destroy liver tumors in two clinical trials in the U.S. and Europe, with the goal of seeking regulatory clearance for the platform in 2022. The technology uses the science of histotripsy, a form of therapeutic focused ultrasound, to mechanically destroy targeted primary and metastatic liver tumors from outside the body.
HONG KONG – Researchers at Ben-Gurion University of the Negev (BGU) in Israel have developed a way to instantly monitor blood levels of the antipsychotic drug clozapine. BGU’s solution is based on an electrochemical microsensor developed by Hadar Ben-Yoav from BGU’s Department of Biomedical Engineering and Ilse Katz Institute for Nanoscale Science and Technology.
A new study by Mayo Clinic and Nference Inc. researchers suggests that prior childhood and adult vaccinations for illnesses such as polio, measles and flu may provide protection against COVID-19 infection. The study, which analyzed patient data using Nference artificial intelligence (AI) software, underscores the critical role immunizations play in curbing the spread of diseases and preventing future pandemics. “What we discovered represents compelling evidence that vaccinations are a critical element in prevention of disease, even diseases one doesn’t anticipate,” said Venky Soundararajan, co-founder and chief scientific officer of the Cambridge, Mass.-based company.
Drug and device companies dragging their feet on diversifying late-stage clinical trials could conceivably get a wake-up call in court or in FDA approval delays.
In 2020, Appliedvr Inc. reported results from a three-week proof-of-concept study showing reduction of lower back pain with the use of its Easevrx virtual reality (VR) therapy. Now the company has pivotal data affirming the benefit to patients with chronic low back pain who used Easevrx at home for eight weeks.
Patensee Ltd. initiated a first-in-human trial of its machine vision-based surveillance system for stenosis in hemodialysis patients. The trial will evaluate the imaging system's ability to perform contact-free surveillance of the access points or fistulas essential for dialysis, which nearly all narrow or become blocked over time. The surveillance system aims to mimic the central components of a dialysis nurse's exam using technology.