October 17, 2022
Labeling for a Medtronic pacing lead, already indicated for stimulation of the His bundle, has been expanded to include the left bundle branch (LBB), the company […]
October 17, 2022
The US Food and Drug Administration has granted 510(k) clearance for Abiomed’s Impella Low Profile Sheath used to place and manage Impella heart pumps. “The Low […]
October 12, 2022
The US Food and Drug Administration (FDA) has approved a furosemide preparation (Furoscix, scPharmaceuticals) intended for subcutaneous self-administration by outpatients with chronic heart failure (HF) and […]
October 7, 2022
The US Food and Drug Administration (FDA) has approved a whooping cough vaccine that protects newborns under 2 months of age. The federal agency on Friday […]
October 4, 2022
The scientific committee of the European Medicines Agency (EMA) has issued a positive opinion of the type II variation application of filgotinib (Jyseleca, Galapagos NV) based […]
October 3, 2022
The US Food and Drug Administration (FDA) has granted an accelerated approval for a new drug, futibatinib (Lytgobi), to be used for patients with a certain […]
September 30, 2022
Device maker LivaNova (TandemLife) has recalled the LifeSPARC controller, part of the LifeSPARC system, because of a software malfunction that may cause the controller’s monitoring feature […]
September 29, 2022
The US Food and Drug Administration (FDA) has approved sodium phenylbutyrate/taurursodiol (Relyvrio, Amylyx Pharmaceuticals), a novel drug to treat amyotrophic lateral sclerosis (ALS). The approval was […]
September 29, 2022
The US Food and Drug Administration has cleared the Nexpowder endoscopic hemostasis system. Nexpowder (Medtronic) uses a noncontact, nonthermal, nontraumatic hemostatic powder that is sprayed through […]