Aiforia Inc., a Cambridge, Mass.-based software company providing artificial intelligence (AI) solutions for medical image analysis, is teaming up with Pathan BV, one of the largest pathology laboratories in the Netherlands. The goal is to build clinically validated AI models to assist pathologists with primary diagnostics, as well as enhance laboratory workflows to make faster and better informed decisions to ultimately improve patient care.
Atc Alert LLC, of Lake Success, N.Y., said the New York Presbyterian Brooklyn Methodist Hospital (NYPBMH) published results from a study that implemented the company’s remote patient monitoring (RPM) program to oversee care in low to moderate-risk COVID-19 patients at home. According to NYPBMH, 91% of patients surveyed said they were satisfied with the care they received through the RPM program. Additionally, 96% of patients felt comfortable taking readings, and 100% said Atc Alert’s platform was easy to use.
Berkshire Biomedical LLC, a privately held digital health company based in Dallas developing a virtual care and intended user prescription drug management system, said that its 510(k) application to the U.S. FDA for premarketing clearance of the Computerized Oral Prescription Administration system was accepted for review.
San Diego-based Biotheranostics Inc. reported the inclusion of the Breast Cancer Index in the National Comprehensive Cancer Network Breast Cancer Guidelines for the prediction of benefit from extended endocrine therapy.
New York-based Brain Scientific Inc. said that it has started the development of its proposed Brain E-Tattoo device for the brain diagnostics market, which is expected to feature a temporary implanted or imprinted minimally invasive, subcutaneous graphene electrode paired with a micro EEG. The proposed device is expected to allow for long-term monitoring capabilities and uninterrupted data collection from patients with neurological conditions, such as epilepsy, Alzheimer’s disease, stroke, and other brain disorders.
Lebanon N.H.-based Cairnsurgical Inc., which is aiming to make breast cancer surgery more precise, said that the first patient has been treated in its U.S. pivotal trial of the Breast Cancer Locator (BCL) system at Massachusetts General Hospital. The BCL system is designed to eliminate guesswork in breast cancer surgery by providing a blueprint of the tumor and a surgical guide to achieve clear margins.
Ghent, Belgium-based Cerba Research said that it has developed two new COVID-19 exploratory tools to enhance clinical research for the development of vaccines and treatments for COVID-19 and other infectious diseases. Developed by scientists at Cerba Healthcare on nasopharyngeal ongoing patient samples, these tools are available and efficient on clinical specimens. Furthermore, this whole-genome sequencing in NGS assay is available for other viruses responsible for respiratory diseases like influenza viruses.
Waltham, Mass.-based Echosens, which offers the Fibroscan family of products, revealed its collaborative relationship with Healthy Trucking of America. The goal of the collaboration is to address liver health among its 770,000 active fleets in the U.S.
Electrocore Inc., of Basking Ridge, N.J., reported that Health Improvement Scotland has published a Scottish Health Technology Group (SHTG) adaptation for NHS Scotland on the use of Gammacore for cluster headache. The SHTG publication recommends that Gammacore, which delivers noninvasive vagus nerve stimulation therapy, should be available for a three-month trial period for use in treating NHS Scotland patients.
Erba Mannheim, of London, launched the Erbamdx SARS-CoV-2 RT-PCR Kit for detection of SARS-CoV-2. The new assay offers 200 copies/ml LoD, using universally trusted gene targets highly specific for SARS-CoV-2 and updated primer sequences to maximize long term performance. Sample types include both nasopharyngeal and oropharyngeal swabs as well as saliva.
Imbiotechnologies Ltd., of Edmonton, Alberta, reported an agreement with Canadian Hospital Specialties, of Oakville, Ontario, to distribute Ekobi embolization microspheres in Canada.
San Carlos, Calif.-based Natera Inc. has filed a lawsuit against Inivata Ltd., of Cambridge, U.K., and its wholly owned subsidiary Inivata Inc., of Morrisville, N.C., alleging infringement of Natera’s ‘755 and ‘709 patients by selling, manufacturing or using various oncology products, including those in the molecular residual disease testing and liquid biopsy spaces. Natera is seeking both injunctive relief and monetary damages.
Numares AG, of Regensburg, Germany, and Billerica, Mass.-based Bruker Corp. are teaming up to bring new diagnostic tests utilizing nuclear magnetic resonance to the laboratory market for unmet medical needs. The tests are based on the automated measurement of metabolites using a strong magnet field and artificial intelligence. The platform is marketed under the Numares brand Axinon.
Orasure Technologies Inc., of Bethlehem, Pa., said its Oragene·Dx saliva collection kit was included as a component in the de novo authorization granted by the U.S. FDA to San Mateo, Calif.-based Helix for the Helix Laboratory Platform, a whole exome sequencing platform.
Salt Lake City-based Polarityte Inc. said it has completed target enrollment of 100 subjects in a randomized, controlled trial evaluating its Skinte plus standard of care (SOC) vs. SOC alone for the treatment of diabetic foot ulcers. The company plans to report topline data at the Symposium on Advanced Wound Care Spring 2021 in May.
Premier Medical Laboratory Services, of Greenville, S.C., said that Diabetespredict, a predictive genetic test for type 2 diabetes, is now being administered to help improve patient outcomes during the COVID-19 pandemic.
Hilden, Germany-based Qiagen NV confirmed the effectiveness of its SARS-CoV-2 PCR tests, Qiastat-Dx and Neumodx, in the face of mutations of the coronavirus. The company started cross-checking variants in May 2020 and continues to conduct biweekly assessments. Separately, Qiagen said it plans to resubmit its Qiareach SARS-CoV-2 antigen test to the U.S. FDA for emergency use authorization by the end of March. The test detects the COVID-19 virus in people with active infections in 15 minutes.
Thomas Scientific LLC, of Swedesboro, N.J., reported the launch of its Molecular Diagnostics business unit dedicated to serving independent testing and reference laboratories in the U.S.
Englewood, Colo.-based Viveve Medical Inc. has launched its pivotal U.S. PURSUIT trial in stress urinary incontinence. The protocol of the multicenter, randomized, double-blind, sham-controlled trial reflects changes to the study design approved by the U.S. FDA in December, including an increase in size to 390 subjects across 30 U.S. sites and better defined inclusion/exclusion criteria related to a diagnosis of moderate stress urinary incontinence (SUI) in subjects. The changes are intended to provide a clearer assessment of the trial’s primary endpoint. If positive, results could support a marketing application for a new SUI indication for Viveve’s cryogen-cooled monopolar radiofrequency technology in the U.S.
Xclinical GmbH, an eClinical vendor based in Munich, Germany, said it will merge with Paris-based Carenity, a social platform supporting patients and caregivers worldwide, and Fortress Medical Systems LLC, the Hopkins, Minn.-based vendor of Clindex, an integrated clinical trial management system and electronic data capture system. Together, the three companies will form a new data science company. Further details of the merger were not disclosed.