Continuous IV monitoring system developer ivWatch announced that it received FDA clearance for its new SmartTouch disposable sensor. SmartTouch is indicated for the early detection of peripheral IV infiltration and extravasation events. The latest FDA clearance expands ivWatch’s sensor portfolio to include the single-use sensor for all patient age groups. It is miniaturized and disposable and […]
Soterix wins IDE for depression treatment trial
Soterix Medical announced today that it received FDA investigational device exemption (IDE) to launch a trial of its tDCS-LTE) neuromodulation system. New York-based Soterix Medical’s transcranial direct current stimulation-limited total energy (tDCS-LTE) system is an at-home platform for people suffering from major depressive disorder (MDD). The proprietary technology is designed to support the home-based tDCS, […]
CVRx reports positive six-month trial results for Barostim Neo
CVRx announced today that it observed positive six-month results from its BeAT-HF trial for the Barostim Neo device for improving symptoms of heart failure. Barostim Neo uses patented technology to send electrical pulses to baroreceptors in the wall of the carotid artery in an effort to restore balance to the automatic nervous system and improve […]
Abbott touts new data for its minimally invasive structural heart therapies
Abbott (NYSE:ABT) today announced late-breaking data on some of its structural heart disease products. The data listed findings on the MitraClip system for transcatheter mitral valve repair, the TriClip system for transcatheter tricuspid valve repair and the Tendyne transcatheter mitral valve implantation system for mitral valve replacement. Clinical and real-world data showed that transcatheter devices can […]
Merck acquires Themis to speed COVID-19 vaccine development
Merck (NYSE:MRK) announced today that it completed the acquisition of vaccine and immune-modulation therapy developer Themis for an undisclosed amount. In connection with the acquisition, the U.S. Federal Trade Commission granted early termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, while Merck gained merger control from the Austrian Federal Competition Authority, […]
FDA expands public-private effort on COVID-19 research
The FDA announced that it is participating in the COVID-19 Diagnostics Evidence Accelerator project to advance the development of diagnostics. Organized by the Reagan-Udall Foundation for the FDA and in collaboration with Friends of Cancer Research, the multi-stakeholder project is the companion to the previously announced Therapeutic Evidence Accelerator for sharing insights, comparing results and […]
Boston Scientific touts SpaceOAR meta-analysis results
Boston Scientific (NYSE:BSX) announced that published results from an analysis of its SpaceOAR hydrogel spacer revealed safe prostate-rectum separation. Marlborough, Mass.-based Boston Scientific has developed the SpaceOAR since its $600 million acquisition of Augmenix in September 2018. The absorbable polyethylene glycol hydrogel spacer won CE Mark approval in the European Union in 2010 and 510(k) clearance from the […]
Medtronic touts results of venous self-expanding stent system study
Medtronic (NYSE:MDT) announced that the clinical trial for its Abre venous self-expanding stent system met its primary safety and effectiveness endpoints. The Abre stent system is designed for treating patients with iliofemoral venous outflow obstruction. The prospective, interventional, single-arm, multi-center, global trial with 200 subjects across 24 sites evaluated primary patency at 12 months for effectiveness […]
CyMedica Orthopedics completes enrollment in clinical trial
CyMedica Orthopedics today said it completed early enrollment of 159 patients in an FDA-regulated clinical trial of its E-Vive pain relief technology. The technology is designed for patients with knee osteoarthritis and is being studied in a randomized, prospective, double-blind, multisite, pivotal trial in adults. The trial will evaluate the company’s patented CyMotion neuromuscular strengthening […]
Medtronic touts results of latest MiniMed studies at ADA
The latest generation of the Medtronic (NYSE:MDT) MiniMed insulin pump met both safety and glycemic endpoints in a study presented today at the American Diabetes Association’s virtual annual conference. The MiniMed 780G closed-loop system is indicated for treating Type 1 diabetes in people aged 7 to 80 years old. It is designed to automate the delivery […]
Regeneron launches clinical trial of COVID-19 antibody ‘cocktail’
Regeneron Pharmaceuticals (NSDQ:REGN) announced today that it initiated the first clinical trial of its dual antibody cocktail for preventing COVID-19. The REGN-COV2 clinical program will include populations of hospitalized COVID-19 patients, non-hospitalized symptomatic COVID-19 patients, uninfected people in groups that have a high risk of exposure (healthcare workers or first responders, for example) and uninfected people […]
- 1
- 2
- 3
- …
- 188
- Next Page »
