Mainstay Medical, an Irish firm, just won FDA approval to introduce its ReActiv8 neurostimulator that works to address the underlying causes of back pain. Most existing pain reducing implants work to simply mask the pain by delivering electrical signals to the relevant nerves. The ReActiv8 instead stimulates the multifidus muscle, that lies next to the...
Tag: <span>FDA</span>
Update on stem cells for COVID-19, Surgisphere scandal
The term Regenerative Medicine covers so much biomedical science these days including everything from just about any kind of cell therapy (not just stem cells) to CRISPR gene editing, and with the the COVID-19 pandemic, it seems this umbrella use of the term now includes potential treatment of viral illnesses. It can be hard to...
FDA greenlights Neuroelectrics to help patients with Major Depression at home amidst Covid-19 restrictions
Neuroelectrics announced that the FDA has approved the Investigational Device Exemption supplemental protocol study submitted by Neuroelectrics to help patients with Major Depression Disorder (MDD) that cannot access their current non-invasive brain stimulation treatment (rTMS* or ECT**) due to COVID-19 related restrictions. COVID-19 pandemic has made evident the urgent need for a safe, effective, home-based...
Butterfly TeleGuidance for Remote Ultrasound Exams During COVID Pandemic
Telemedicine has been around for over a decade in various forms, but the COVID-19 epidemic has turned a convenience into a necessity. Clinical practices that never seriously considered using telemedicine are now performing virtual house calls with their patients. However, although it’s possible to do a lot through a video call, many procedures such as...
Artificial intelligence jump starts clinical trial for rare genetic disease
by Bob Shepard, University of Alabama at Birmingham It was a pretty simple e-mail. Just a couple of lines. “It looks like low-dose ketamine is an up-regulator for ADNP. Do you think this makes sense for ADNP patients?” Matt Might sent that e-mail to Matt Davis on Feb. 18, 2019. Might is the director of...
E1912 trial leads to FDA approval of ibrutinib-rituximab combo for untreated CLL
Philadelphia, April 29, 2020–Patients with untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma now have a new treatment option–a combination of the targeted agent ibrutinib with the immunologic agent rituximab. The U.S. Food and Drug Administration (FDA) has approved the combination based on data from E1912, a phase 3 trial developed and led by...
Which coronavirus antibody tests actually work? Study finds most were over 95% accurate with three over 99% reliable’
By JENNIFER SMITH FOR DAILYMAIL.COM Researchers in San Francisco and some in Massachusetts studied 14 different antibody tests Among them, only three returned results that were more than 99% specific in detecting antibodies One test, made by Sure Biotech which is registered in both the US and Hong Kong, had a 100% accuracy rate The...
COVID-19: Stem Cell Therapy Shows 83% Survival of Coronavirus Patients, Study Found
By Tiziana Celine Tech Times Doctors are hoping stem cell therapy may be a weapon in the fight against coronavirus. Regenerative medicine employer Mesoblast introduced a 300-person trial on Friday, Apr. 24, to decide whether or not stem cell treatments will work in COVID-19 patients tormented by severe lung inflammation. The treatments had been intravenous...
FDA Approves Phase II Trial of Hope Biosciences’ MSCs Against COVID-19
Autologous Mesenchymal Stem Cells to Provide Immune Support Against COVID-19 HOUSTON, April 6, 2020 — Hope Biosciences, a clinical stage biotechnology company focused on developing cell-based therapeutics for acute and chronic disease, today announced that FDA has approved a Phase II clinical trial evaluating efficacy and safety of Hope Biosciences’ autologous, adipose-derived mesenchymal stem cells...
Milestone for the early detection of sepsis
By: LUNGHAMMER – TU GRAZ Whether activating or silencing genes, breaking down defective cells or building new tissue, our body is constantly working to repair itself, even in cases of illness. To fight a disease, our body sends out signals, often long before we ourselves notice the disease. Such signals are, for example, DNA molecules...