HeartBeam wins FDA nod for at-home ECG tech
December 16, 2024
HeartBeam (Nasdaq:BEAT) announced today that it received FDA 510(k) clearance for its comprehensive arrhythmia assessment system.
HeartBeam (Nasdaq:BEAT) announced today that it received FDA 510(k) clearance for its comprehensive arrhythmia assessment system.
Withings Health Solutions announced today that it received FDA clearance for BPM Pro 2, a first-of-its-kind cellular blood pressure monitor.
ALBUQUERQUE, N.M., Dec. 16, 2024 /PRNewswire/ — Gastro Concepts, a team committed to advancing safety and efficiency in gastroenterology, today announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its groundbreaking Air Assist™ device.
A pivotal study of the robotic platform in colorectal surgery will begin at five hospitals in early 2025.
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.