Cizzle Bio’s South Texas laboratory deal widens CIZ1B reach, but the real test starts now
Cizzle Bio’s BioBridge Global collaboration widens CIZ1B access in South Texas, but validation, reimbursement and evidence remain decisive.
Medical Devices & Diagnostics
Medical Devices & Diagnostics
Can Invenio Imaging’s AI deliver reliable lung biopsy feedback inside the bronchoscopy room?
Invenio Imaging completes ON-SITE enrolment as NIO Lung Cancer Reveal moves toward pivotal analysis and a potential FDA submission.
Medical Devices & Diagnostics
How BIOTRONIK Neuro is using artificial intelligence to support spinal cord stimulation patients
BIOTRONIK Neuro adds AI-guided outreach to Prospera SCS, but broader validation will determine its impact on chronic pain support.
Medical Devices & Diagnostics
What SoundHealth’s latest funding means for Sonu, Spatial Sleep and digital health growth
SoundHealth’s latest Series A takes total funding to $12.25 million as Sonu and Spatial Sleep enter a tougher commercial scale-up phase.
Medical Devices & Diagnostics
FDA classifies Resmed Astral ventilator correction as Class I after five serious injuries
The United States Food and Drug Administration (FDA) has classified Resmed Ltd.’s correction of certain Astral 100 and Astral 150 ventilators as a Class I recall after a leaking internal component was linked to five serious injuries and the potential for ventilation therapy to stop without warning. The action covers 168,069 devices distributed worldwide and
Medical Devices & Diagnostics
FDA approves MannKind Furoscix ReadyFlow autoinjector for at-home fluid overload treatment
The United States Food and Drug Administration (FDA) has approved MannKind Corporation’s Furoscix ReadyFlow, a prefilled autoinjector that delivers 80 milligrams of subcutaneous furosemide in about ten seconds for adults experiencing edema associated with chronic heart failure or chronic kidney disease. The July 24 approval creates a faster alternative to the existing Furoscix On-body Infusor,
Medical Devices & Diagnostics
Picard Medical unveils Emperor electromechanical architecture for next-gen artificial heart
Picard Medical has publicly presented the integrated architecture of its Emperor Total Artificial Heart for the first time, revealing how a compact electromechanical drive system could eventually replace the external pneumatic equipment used to power the existing SynCardia Total Artificial Heart. The preliminary architecture was presented at the 48th Annual International Conference of the IEEE
Medical Devices & Diagnostics
Can Canon Medical’s imaging reach turn eyonis LCS regulatory success into hospital adoption?
Median Technologies and Olea Medical will deploy eyonis LCS across United States and European lung cancer screening workflows.
Medical Devices & Diagnostics
Can RecovryAI’s Virtual Care Assistant secure FDA De Novo authorization?
RecovryAI completes a 525-patient pivotal study phase as it prepares an FDA De Novo filing for postoperative clinical AI.
Medical Devices & Diagnostics
Can One Biosciences bring single-cell transcriptomics into routine cancer pathology?
One Biosciences reports an FFPE single-cell workflow across six cancers, but clinical utility and prospective validation remain the next tests.