The U.S. FDA’s discussion paper for health equity for medical devices reiterates standing policy on clinical trial enrollment, such as that the device’s pivotal study should be reflective of the intended use population.
Ondine Biomedical Inc.’s Steriwave light-activated antimicrobial technology will be used in a pilot program at Leeds Teaching Hospitals NHS Trust in the U.K. to help fight infections in patients undergoing skull base sinus surgery. The Steriwave technology offers a quick nasal decolonization treatment that reduces the need for antibiotics and the risk of postoperative infections.
Lest there’s any confusion, Lucid Diagnostics Inc. published promising results from a third study showing the benefit of its non-invasive Esoguard test for detecting esophageal cancer and precancer conditions.
Immunovia AB significantly increased the accuracy of its test for the early detection of pancreatic cancer, achieving an 85% sensitivity and a specificity of 98%.
With the COVID-19 pandemic still visible in the rearview mirror, the World Health Organization (WHO) is taking no chances as it preps for human avian influenza, or H5N1, a subtype of influenza A.
The first patenting to be published in the name of Wave View Imaging Inc. sees its co-founders file for additional protection of their imaging technology which can be used to monitor breast cancer treatment.
The first economic modelling of Boston Scientific Corp.’s pulsed field ablation system in U.K.’s National Health Service showed that it is more cost-effective as a treatment for paroxysmal atrial fibrillation compared to standard cryoablation.
AI-focused medical diagnostics company Spectral AI Inc. is collaborating with burn wound therapy company Polynovo Ltd. to test limited deployment of Spectral’s Deepview system for predicting burn healing in Australia.
Know Labs Inc.’s radiofrequency sensor accurately classified blood glucose levels more than 93% of the time, a study published in Diabetes Technology & Therapeutics found. That’s good news for people with diabetes, who may be able to use the non-invasive technology to avoid not just the needle sticks that used to be the hallmark of diabetes management, but even the microneedles used in current continuous glucose systems.
Soligenix Inc. investors were extremely enthusiastic about the positive interim update for the company’s cancer therapy and light device, Hybryte, for treating for treating early stage cutaneous T-cell lymphoma. The Princeton, N.J.-based company’s stock (NASDAQ:SNGX) soared a whopping 464% before closing at a more modest but still massive of 271% increase to $7.42 each on July 9.