Abbott Laboratories’ Cardiomems heart failure (HF) system is open to a larger patient population following an expanded approval from the FDA. Abbott’s system had previously been approved for class III HF patients that had been hospitalized for HF in the past year. A new expanded indication enables the sensor to be utilized by class II (earlier stage) HF patients and those whose blood test show elevated levels of biomarkers known as natriuretic peptides. The FDA based the approval on findings from the GUIDE-HF trial, which suggested class II HF patients and patients with elevated natriuretic peptides had better outcomes when their therapy was guided by pulmonary pressure monitoring, with a 34% and 25% reduction in heart failure hospitalizations and emergency visits, respectively, based on study data adjusted for the impact of COVID-19. Read More
Several recent studies highlight the rapidly expanding applications for neuromodulation using bioelectronic devices. A pair of articles in the Journal of the American Heart Association and Journal of the American College of Cardiology focused on the benefits to patients with heart failure and those at risk of post-operative atrial fibrillation, respectively. A study published in Brain Stimulation found that 85% of tinnitus patients experienced resolution of their symptoms when using a neuromodulation device. Read More
The U.S. FDA has at last published what is nominally a draft rule for harmonization of the Quality System Regulation (QSR) with an international standard, ISO 13485, but the draft rule is conspicuous for the absence of specifics. Read More
LONDON – Oxford University spinout Oxdx Ltd. has raised £2.6 million (US$3.6 million) in pre-seed funding to advance development of a technology for directly identifying infectious pathogens without the need to purify, culture or amplify samples first. The instant testing method uses a mixture of a single universal reagent, high resolution microscopy and machine learning, to identify specific species and strains of bacteria, viruses and other pathogens within minutes. Read More
Med-tech financings in 2022 appear to be off to a bumpy start. The total amount raised in the first six weeks of the year is at its lowest point in comparison with each of the previous three years. Nevertheless, venture capital rounds, showing no signs of slowing from 2021’s record year, are accounting for the bulk of the activity. Read More
Tariffs applied to goods imported for China were imposed by the Trump administration as part of a larger effort to reset the U.S. trade deficit, but there were several exclusions for medical devices in the interest of maintaining access. Read More
Med-tech firms raising money in public or private financings, including: Applied DNA Sciences, Automata, Meihua International, Neuronetics, Semarion. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Adaptive Biotechnologies, Neruomod Devices. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alpha Tau Medical, Alice, Bio-Techne, Brainlab, Cerveau Technologies, Delcath, FX Shoulder, FX Solutions, Infusystem, Labcorp, Medac, Microvention, Nihon Medi-Physics, Personal Genome Diagnostics, Safe Orthopaedics, Signifier Medical, Solo-Dex, Terumo, Thermo Fisher Scientific, Tytocare. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Foundation Medicine, Gramercy Extremity Orthopedics, Lumiradx, Olympus, Precisis. Read More
