The FDA has identified the Abbott (NYSE:ABT) recall of its Dragonfly OpStar Imaging Catheter as a Class I recall. That’s the most serious level of a medical device recall, carrying the risk of serious injury or death. Five incidents, one injury and zero deaths were reported when Abbott initiated the recall on April 11. The […]
Regulatory/Compliance
DoMore Diagnostics wins CE mark for AI algorithm that predicts colorectal cancer outcomes
DoMore Diagnostics announced that it received CE mark approval in Europe for its Histotype Px Colorectal deep learning algorithm. Oslo, Norway-based DoMore designed its Histotype Px Colorectal deep learning algorithm to predict colorectal cancer patient outcomes based on analysis of digital histology images. The company said in a news release that the algorithm, which builds […]
FDA grants IDE for MedAlliance’s sirolimus-eluting balloon
MedAlliance announced today that it received FDA investigational device exemption (IDE) for its Selution SLR drug-eluting balloon. Geneva, Switzerland-based MedAlliance designed its Selution SLR (sustained limus release) novel sirolimus-eluting balloon to provide a controlled sustained drug release, similar to a drug-eluting stent. Get the full story at our sister site, Drug Delivery Business News.
Medtronic ‘hopeful’ on FDA clearance for next-gen diabetes tech in FY 2023
The Medtronic (NYSE:MDT) diabetes business sputtered in the fourth quarter but could be bolstered by a major regulatory nod this year. The Fridley, Minnesota-based company saw revenues for its diabetes arm fall by 7.7% year-over-year in the fourth quarter amid overall misses on both sales and adjusted earnings per share compared to Wall Street’s expectations. […]
Device developer SeaStar Medical hires chief medical officer
SeaStar Medical has hired Dr. Kevin Chung as chief medical officer of the medtech developer starting July 1. Denver-based SeaStar is developing a platform therapy focused on hyperinflammation of vital organs. The company’s Selective Cytopheretic Device was designated as a breakthrough device by the FDA earlier this year. SeaStar is set to go public in the […]
inHeart wins FDA clearance for 3D cardiac modeling software
inHeart announced today that it received FDA 510(k) clearance for its inHeart Models software suite for cardiac modeling. France-based inHeart designed its inHeart Models software to enable the 3D visualization and analysis of anatomical structures for pre-procedural planning and intraprocedural use. FDA clearance allows for the expansion of the company’s commercial footprint in the U.S. […]
Anumana wins FDA breakthrough nod for AI algorithm that detects pulmonary hypertension
Anumana announced today that it received FDA breakthrough device designation for its pulmonary hypertension (PH) early detection algorithm. Cambridge, Massachusetts-based Anumana, formed by Mayo Clinic and nference and launched in 2021, designed its AI-enhanced, electrocardiograph (ECG)-based PH early detection algorithm as a precise, non-invasive screening tool to provide earlier diagnosis for patients with PH that […]
FDA clears RapidAI’s pulmonary embolism triage platform
RapidAI announced today that it received FDA 510(k) clearance for its Rapid PE Triage & Notification product. San Mateo, California-based RapidAI designed its Rapid PE Triage & Notification product for the fast identification and communication of suspected central pulmonary embolism (PE). According to a news release, Rapid PE Triage & Notification works in conjunction with […]
Henry Schein investors push back on executive pay
Nearly half of Henry Schein (Nasdaq:HSIC) shareholders who voted at this month’s annual meeting voted against the company’s pay packages for top executives, according to a new SEC filing. About 48.5% of voting shareholders voted against the company’s executive pay plan in what’s known as the Say-on-Pay vote, according to vote results of the May 18 […]
Pfizer, BioNTech moving forward on seeking COVID-19 vaccine EUA for youngest children
Pfizer (NYSE:PFE) and BioNTech (Nasdaq:BNTX) announced today that data support a three-dose primary series of their COVID-19 vaccine in young children Topline safety, immunogenicity and vaccine efficacy data from a Phase 2/3 trial evaluating a third 3-µg dose of the vaccine — marketed in the U.S. as Comirnaty — showed a strong immune response and […]
FDA says Philips ventilator recall produced over 21,000 device reports, 124 deaths
The FDA updated its communications on Philips‘ (NYSE:PHG) major ventilator recall with new data on device reports and patient deaths. In June 2021, Philips Respironics recalled millions of certain ventilators, bi-level positive airway pressure (BiPAP) and continuous positive airway pressure (CPAP) machines due to potential health risks caused by polyester-based polyurethane (PE-PUR) sound abatement foam […]
