MedTech News
Gerresheimer: FDA grants Tentative Approval of SQ Innovation’s Lasix® ONYU
DÜSSELDORF, Germany, Dec. 16, 2024 /PRNewswire/ — Gerresheimer, an innovative system and solution provider and a global partner for the pharma, biotech and cosmetics industries, announces that the US Food and Drug Administration (FDA) granted SQ Innovation Tentative Approval for Lasix ONYU for the home treatment of fluid overload in congestive heart failure.
Zimmer receives FDA nod for stemless shoulder implant
The Osseofit devices are intended to match patients’ shoulder bone anatomy and preserve healthy bone in total shoulder replacement procedures.
HeartBeam wins FDA nod for at-home ECG tech
HeartBeam (Nasdaq:BEAT) announced today that it received FDA 510(k) clearance for its comprehensive arrhythmia assessment system.
Withings wins FDA clearance for first-of-its-kind blood pressure monitor
Withings Health Solutions announced today that it received FDA clearance for BPM Pro 2, a first-of-its-kind cellular blood pressure monitor.
Photocurrent-responsive coating cuts bone-to-implant integration time in half
A research team has developed an innovative photocurrent-responsive implant surface to accelerate bone-to-implant integration after orthopedic surgery.
Endoquest robotic system gets FDA OK to launch clinical trial
A pivotal study of the robotic platform in colorectal surgery will begin at five hospitals in early 2025.
Wearable patch can monitor breathing to help save lives
Scientists have developed a wearable patch that can accurately monitor and detect changes in people’s breathing—even when not in direct contact with the skin.
Tiny sensors offer new hope for faster bone injury recovery
Tiny implantable sensors are helping University of Oregon researchers optimize the process of recovery from severe bone injuries.