SHINE Technologies receives EU CMA for Ilumira Lu-177 radioisotope
June 1, 2026
The development coincides with several steps by SHINE Technologies to broaden its position in nuclear medicine.
The development coincides with several steps by SHINE Technologies to broaden its position in nuclear medicine.
SEOUL, South Korea, May 29, 2026 /PRNewswire/ — South Korea-based medtech innovator SKIA has announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its augmented reality (AR) surgical guidance system, SKIA HEAD.
Coredio’s AI software is used to monitor HF parameters via wearables and standard blood pressure cuffs.
MannKind (Nasdaq:MNKD) announced today that it received FDA approval for its Afrezza inhaled insulin powder for children.
Decnupaz is the first antibody-drug conjugate for blastic plasmacytoid dendritic cell neoplasm, an ultra-rare and aggressive blood cancer.
Procept BioRobotics (Nasdaq:PRCT) announced today that it received FDA investigational device exemption (IDE) for a second Aquablation evaluation.
SINGAPORE, May 27, 2026 /PRNewswire/ — Gene Solutions, a global biotechnology company advancing accessible genomic solutions for cancer detection and precision oncology, today announced that the U.S. Food and Drug Administration has granted Breakthrough Device Designation to SPOT-MAS 10, its multi-omic blood test designed to detect cancer-associated signals.
Spectral AI announced that the U.S. Food and Drug Administration (FDA) has granted De Novo classification for its DeepView System, authorizing the company to commence commercial distribution activities in the United States.
California-based Subtle Medical has announced FDA clearance for SubtleHD(PET), its next-generation PET image enhancement solution designed to improve image quality and accelerate PET imaging workflows across PET/CT and PET/MR systems.
Chicago, Illinois-based Cardiosense announced that the US Food and Drug Administration (FDA) has granted De Novo classification for its PCWP Analysis Software, which is designed to estimate noninvasively pulmonary capillary wedge pressure (PCWP), a key indicator of heart health.