
FDA grants humanitarian device exemption to Artivion’s aortic arch remodeling device
Artivion (NYSE:AORT) this week announced it received FDA humanitarian device exemption (HDE) for its AMDS hybrid prosthesis.
Artivion (NYSE:AORT) this week announced it received FDA humanitarian device exemption (HDE) for its AMDS hybrid prosthesis.
EndoQuest Robotics announced today that it received FDA investigational device exemption (IDE) for a study of its surgical robot.
BEIJING, Dec. 9, 2024 /PRNewswire/ — Concord Medical Services Holdings Limited (“Concord Medical” or the “Company”) (NYSE: CCM), a healthcare provider specialized in cancer treatment, research, education and prevention in China, today announced that the National Medical Products Administration of the People’s Republic of China has granted approval to the application for the Registration Certificate for Medical Device for the proton therapy equipment (the “Registration Certificate”) made by the Company’s equipment supplier on December 6, 2024.
Stereotaxis (NYSE:STXS) announced today that its Magbot magnetic navigation ablation catheter received regulatory approval in China.
AngioDynamics today announced it received FDA 510(k) clearance for its NanoKnife system for prostate tissue ablation in patients with intermediate-risk prostate cancer.
Lungpacer Medical announced that it received FDA premarket approval for its flagship AeroPace neurostimulation system.
The solution offers clinical laboratories and healthcare providers a user-friendly, reliable, and cost-effective way to improve urine specimen collection, preservation, and transport.
LINKÖPING, Sweden, Dec. 6, 2024 /PRNewswire/ — SyntheticMR, leader in quantitative imaging software, is pleased to announce that its SyMRI 15 solution has obtained 510(k) clearance from the U.S. Food and Drug Administration (FDA) on diagnostic image replacement of conventional images.
Field Medical announced today that it received FDA breakthrough device designation for its FieldForce pulsed field ablation (PFA) system.
A new medical innovation, developed in the UK by Europlaz, has the potential to help improve neonatal care and save the lives of more babies born prematurely or in distress according to the company.