The FDA has issued an early alert involving Abiomed Automated Impella Controllers after purge-cassette recognition failures were associated with 37 serious injuries and three deaths, prompting replacement of controller components used with life-sustaining heart pumps.
Boston Scientific is removing all Imager II angiographic catheters from use after discovering that reduced stabilizing agents in catheter tips could increase degradation and detachment risk, while the medtech company simultaneously works through a separate global cyber disruption.
The FDA has issued an early alert involving certain Medtronic and Given Imaging Bravo CF esophageal pH capsule delivery devices after reports of 184 serious injuries linked to deployment failures that can lead to aspiration, perforation, airway obstruction and bleeding.
Avulux has received FDA De Novo authorization for an over-the-counter precision optical filter that selectively blocks wavelengths associated with migraine-related light sensitivity while allowing much of the remaining visible spectrum through.
Roche has secured FDA clearance for Elecsys pTau217, a single-biomarker blood test capable of supporting both rule-in and rule-out assessment of Alzheimer’s-associated amyloid pathology across primary and specialty care.
Roche has secured expanded FDA approval for two HER2 companion diagnostics used to identify gastroesophageal adenocarcinoma patients who may be eligible for Jazz Pharmaceuticals’ ZIIHERA.
Virtual Incision has secured FDA 510(k) clearance for its miniature MIRA robotic-assisted surgery system in benign hysterectomy, extending the platform beyond colectomy into gynecologic surgery.
Tempus AI has received FDA 510(k) clearance for ECG-PH, artificial-intelligence software that analyzes routine 12-lead electrocardiograms for signs associated with elevated pulmonary artery pressure in symptomatic adults without a known pulmonary-hypertension diagnosis.
Abbott Laboratories has secured FDA De Novo authorization for Libre Duo 10 Day, the first wearable in the United States to continuously monitor ketones and the first device globally to continuously measure glucose and ketones together.
Cytrellis has commercially launched ellacor in Australia after TGA registration of its Class IIa handpiece and cartridge, opening a broader body-resurfacing market for its nonthermal Micro-Coring platform.