Philips gets FDA clearance for flexible MR coil
May 1, 2026
Philips (NYSE:PHG) announced that it received FDA 510(k) clearance for its Smart Fit TorsoCardiac magnetic resonance (MR) 1.5T coil.
Philips (NYSE:PHG) announced that it received FDA 510(k) clearance for its Smart Fit TorsoCardiac magnetic resonance (MR) 1.5T coil.
Agitated Solutions announced that it received CE mark approval for its novel Orbis microbubble generator device.
Zeta Surgical announced today that the FDA granted 510(k) clearance for its Zeta Navigation System and its navigated Stylet and Bolt instruments.
The TAVVE study will begin later this year with ten patients, whose 30-day safety results will be submitted to the FDA.
Orchestra BioMed (Nasdaq:OBIO) announced today that it received a second FDA breakthrough device designation for its AVIM therapy.
Avatar’s software translates CT and MR imaging data into 3D images to streamline surgical planning and operating room workflows.
Medtronic (NYSE:MDT) announced today that it received FDA approval for its Mosaic Neo mitral bioprosthesis and began its U.S. launch.
Earflo announced that it received FDA clearance for its non-invasive device designed to treat negative middle ear pressure in children.
Medtronic (NYSE:MDT) announced today that it received CE mark approval for its Stealth AXiS surgical robot platform.
Abbott (NYSE:ABT) announced today that it received FDA clearance and CE mark for its next-generation Ultreon 3.0 software.