Medtronic (NYSE:MDT) announced today that it received FDA 510(k) clearance for its UNiD spine analyzer v4.0 planning platform. The UNiD spine analyzer v4.0 includes a new Degen algorithm for degenerative spine procedures. The algorithm is designed to leverage machine learning to help surgeons plan and personalize procedures for patients undergoing lower lumbar spine surgery and […]
FDA
FDA clears Eko’s AI for detecting heart disease
Eko announced today that it received FDA clearance for its Eko Murmur Analysis Software (EMAS) for adult and pediatric patients. The next generation of Eko’s murmur detection capabilities, EMAS represents the first and only smart stethoscope on the market that can identify and differentiate between innocent and structural heart murmurs indicative of valvular heart disease. […]
Abbott wins breakthrough nod for deep brain stimulation for managing severe depression
Abbott (NYSE:ABT) announced today that it received FDA breakthrough device designation for its deep brain stimulation (DBS) system. The breakthrough nod allows Abbott to investigate the use of its DBS system in treatment-resistant depression (TRD), a form of major depressive disorder (MDD). Abbott Park, Illinois-based Abbott designed its DBS system as a personalized, adjustable therapy […]
Ancora Heart’s AccuCinch ventricular restoration system wins FDA breakthrough nod
Ancora Heart announced today that it received FDA breakthrough device designation for its AccuCinch ventricular restoration system. Santa Clara, California-based Ancora Heart designed its AccuCinch system to provide a minimally invasive treatment option for patients who have symptomatic heart failure (HF) with reduced ejection fraction (HFrEF). The company is currently evaluating the system in the […]
Blackrock Neurotech and Pitt work on first at-home BCI system for remote trials
Blackrock Neurotech and the University of Pittsburgh’s Rehab Neural Engineering Labs (Pitt RNEL) are working together on the first portable brain-computer interface (BCI) to allow patients to participate in research trials from home. A Blackrock representative said it’s the final step as the company prepares to launch its first commercial product early next year. Salt Lake […]
GE Healthcare’s Carescape ventilator battery recall is Class I
The FDA issued a notice today labeling the recall of GE Healthcare’s (NYSE:GE) Carescape R860 ventilator as Class I, the most serious kind. GE Healthcare recalled the Carescape R860 ventilator backup batteries, including replacement backup batteries, because the batteries may run out before they are expected to do so. If the ventilator is running on […]
Philips updates on testing results for recalled ventilators
Royal Philips (NYSE:PHG) says only a small portion of returned respiratory devices displayed the sound abatement foam degradation that sparked a massive recall. Repeated ozone cleaning may have made the problem worse. Those were some of the major takeaways from an update Philips provided today on a comprehensive test and research program it implemented after […]
Varian wins FDA IDE for Flash radiation therapy
Varian announced today that it received FDA investigational device exemption IDE to advance its Flash clinical research program. Flash therapy, an experimental treatment modality, was designed to deliver radiation therapy at ultra-high dose rates in typically less than one second. The Siemens Healthineers company will conduct the feasibility study of Flash therapy for the treatment […]
Baxter’s Volara lung therapy system recall is Class I
The FDA issued a notice today labeling the recall of the Baxter (NYSE:BAX) Volara lung therapy system as Class I, the most serious kind. Earlier this month, Baxter announced that it issued an urgent medical device correction for its Volara system for oscillation and lung expansion (OLE) therapy. To date, there has been one complaint […]
How SeaStar’s device calms hyperinflammation — and could prevent lasting damage from COVID cytokine storms
SeaStar Medical recently won FDA breakthrough device designation for a new way to treat hyperinflammation with technology that could help fight chronic conditions from COVID-19 infections. The Denver-based medical developer is seeking a humanitarian device exemption for treating children with acute kidney injury (AKI) based on an FDA-funded study, SeaStar President and CEO Eric Schlorff […]
FDA grants breakthrough nod for Carthera’s SonoCloud-9
Carthera announced today that it received FDA breakthrough device designation for its SonoCloud-9 system. Paris-based Carthera designed SonoCloud-9 for implantation in a skull window below the skin. Once in place, the device becomes invisible. When activated for a few minutes using a transdermal needle connected to an external control unit, it uses low-intensity pulsed ultrasound […]