The use of the Indica Labs HALO AP Dx software for review of images acquired with the NanoZoomer® S360MD Slide scanner produced by Hamamatsu brings another option for digital primary diagnosis to anatomic pathology laboratories.
Medtronic (NYSE: MDT)+
officials say the company received FDA clearance for the next-generation PillCam Genius SB capsule endoscopy kit.
ADDISON, Texas , May 16, 2024 /PRNewswire/ — FX received 510k clearance for its full-wedge augmented glenoid baseplates. The newly cleared baseplates bring 6 new options to the previously cleared portfolio. There are now a combined total of 18 glenoid baseplate options to the market to address a variety of surgeon needs. Augmented glenoid baseplate options have continued to become a growing solution for surgeons to address bone loss, defects, or complicated morphologies of the glenoid.
CARLSBAD, Calif., May 15, 2024 /PRNewswire/ — DCN Dx, a leading contract research organization for in vitro diagnostics, today acknowledges the FDA’s Emergency Use Authorization (EUA) of the WELLlife™ COVID-19/Influenza A&B Test, developed by Wondfo USA. This important authorization will enable healthcare professionals to differentiate rapidly between COVID-19 and influenza infections, enhancing patient care at the point-of-care.
Atraverse Medical announced today that the FDA cleared its Hotwire radiofrequency guidewire left-heart access device.
Profound Medical (Nasdaq:PROF) announced today that it received FDA 510(k) clearance for its second AI model for treating prostate cancer.
The FDA has warned that home test users, caregivers and healthcare providers should not use Cue Health COVID-19 diagnostics.
LAKEWOOD, Colo., May 9, 2024 /PRNewswire/ — Terumo Blood and Cell Technologies (Terumo BCT), a medical technology company, recently received U.S. Food and Drug Administration (FDA) 510(k) clearance for the Rika Plasma Donation System™ with the iNomi™ Nomogram. This innovation means that plasma collection volume can be determined by an individual donor’s height, weight and hematocrit level on the day they donate plasma.
Orthofix (Nasdaq: OFIX)+
today announced it received FDA 510(k) clearance for its Rodeo Telescopic Nail.
OrthoXel announced that it received FDA 510(k) clearance for its Vertex hip fracture nail (HFN) for fracture fixation.