FDA grants clearance for Eyas Medical Imaging’s neonatal MRI system
February 6, 2026
Eyas Medical Imaging is currently scaling up operations with plans to commercialise the system in the US later this year.
Eyas Medical Imaging is currently scaling up operations with plans to commercialise the system in the US later this year.
Sonorous Neurovascular received FDA breakthrough device designation for its BosSTENT device intended to treat pulsatile tinnitus, the company announced on Thursday.
VIENNA, Feb. 5, 2026 /PRNewswire/ — P&F Products and Features GmbH, a global heart valve MedTech company focused on transcatheter solutions for structural heart disease, today announced it has received CE Mark certification under the European Union Medical Device Regulation (MDR) 2017/745 for its TricValve® Transcatheter Bicaval Valve System. The certification confirms TricValve’s compliance with the EU’s most stringent medical device regulatory requirements.
FORT LAUDERDALE, Fla., Feb. 5, 2026 /PRNewswire/ — The Bezier Parametric Curve Rod System from Spinal Resources, Inc. has received 510(k) clearance for compatibility with any cleared pedicle screw set available on the US market, regardless of manufacturer.
With this FDA approval, Hologic now offers three guideline-recommended methods: Pap testing, HPV primary testing, and co-testing.
The implantable blood pressure sensor will now be available to patients with chronic heart failure through the NHS.
Zimmer Biomet (NYSE: ZBH)+
announced today that it received FDA 510(k) clearance for its G7 acetabular system for hip replacement surgeries.
OKLAHOMA CITY, Feb. 4, 2026 /PRNewswire/ — Acarix today announced its CADScor®System has successfully achieved certification under the European Union Medical Device Regulation (EU MDR 2017/745).
TSC Life announced that it received FDA clearance for its Fluido Compact fluid warming system for pediatric use.
RevealDX’s software analyses CT scans and assigns lung nodules with a Malignancy Similarity Index score to aid in lung cancer diagnosis.