FemPulse wins FDA IDE for for overactive bladder neuromod
December 11, 2024
FemPulse announced today that it received FDA investigational device exemption (IDE) approval for its overactive bladder (OAB) therapy.
FemPulse announced today that it received FDA investigational device exemption (IDE) approval for its overactive bladder (OAB) therapy.
MONTVALE, N.J., Dec. 10, 2024 /PRNewswire/ — PENTAX Medical, a division of HOYA Group, has obtained US FDA 510(k) clearance for new models of the PENTAX Medical i20c Video Endoscope Series—PENTAX Medical Video Colonoscope EC34-i20cL, PENTAX Medical Video Upper GI Scope EG27‑i20c and Right/Left Wheel Extender OE-B17.
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.
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.
MILPITAS, Calif., Dec. 5, 2024 /PRNewswire/ — LifeSignals, Inc. today announced that the UbiqVue 2A Multiparameter System has received EU MDR Certification, marking another significant milestone in deploying continuous wireless patient monitoring for population health management following FDA 510(k) Clearance last month.