Irish medtech company reaches major regulatory milestone for AI-powered technology providing rapid, objective insights into newborn brain activity
Newly Issued Patent Covers Methods of Promoting Disc Regeneration Using Components Derived from Stimulated Fibroblasts
MiniMed (Nasdaq: MMED) today reported Street-beating first-quarter revenue, upping its full-year sales guidance as it notched an early European regulatory win.
GE HealthCare announced it has received the CE Mark for its Photonova Spectra system, a photon-counting computed tomography (PCCT) system integrated with the company’s Deep Silicon detector technology.
The FDA granted the approval of Revolution Medicines’ daraxonrasib, now to be known as Rasonque, in pancreatic adenocarcinoma 6.5 months ahead of deadline.
Lisraya carries a boxed warning typical of JAK inhibitors, but otherwise has a broad label that allows use in all adults with the rare autoimmune disease, setting up the drug for blockbuster status in a few years, according to Leerink.
With the approval, Eli Lilly’s Mounjaro becomes the first dual GIP/GLP-1 receptor agonist indicated to lower the risk of heart attack, stroke or cardiovascular death in adults with type 2 diabetes.
Investigational K-911 is a once-daily nitric oxide-donating bimatoprost eye drop designed to lower intraocular pressure
Abbott’s (NYSE: ABT) Amulet 360 left atrial appendage (LAA) occlusion device received CE mark, the company announced today.
Paradromics received FDA approval to expand the types of computing devices that could be used with its investigational brain-computer interface (BCI) system, the company told MassDevice.