Nipro Corporation has commercially launched its FDA-cleared ELISIO-HX dialyzer in the United States, offering dialysis providers a medium cut-off membrane designed to remove larger uremic toxins through existing hemodialysis equipment and workflows.
Wearable devices are moving beyond step counts and wellness tracking to become clinical-trial instruments, but regulatory acceptance will depend on whether sponsors can prove that digital endpoints are accurate, meaningful and reliable across diverse patient populations.
Eli Lilly and Company has created a limited expanded-access pathway for adults with severe, treatment-resistant obesity, even as regulators warn that products sold online as retatrutide are unapproved, potentially contaminated and illegal to compound.
Medtronic has secured an expanded European CE Mark indication for its Affera Mapping and Ablation System with the Sphere-9 catheter, allowing the platform to treat ventricular arrhythmias including ventricular tachycardia and premature ventricular complexes. The August 6, 2026 regulatory expansion moves Sphere-9 beyond the atrial arrhythmias for which the system was initially commercialized. Medtronic describes
Capricor Therapeutics faces an August 22 FDA decision for deramiocel after advisers voted that the available evidence did not establish effectiveness in Duchenne muscular dystrophy cardiomyopathy. The disputed case now turns on statistical methods, the treatment indication and whether supportive upper-limb results can overcome unresolved cardiac evidence.
Johnson & Johnson has received FDA De Novo authorization for the OTTAVA robotic surgical system across multiple upper-abdominal procedures. Its table-integrated design could bring robotic surgery into smaller operating rooms, but clinical evidence, surgeon training and hospital economics will determine whether it can challenge Intuitive Surgical.
Alzheimer’s blood tests are moving from specialist research into clinical practice after real-world evidence showed that biomarker results sharply improved diagnostic accuracy. The opportunity is substantial, but differences between assays, inappropriate screening and laboratory-quality failures could undermine confidence.
Replimune Group is awaiting a delayed FDA decision on RP1 after advisers voted that its melanoma results were clinically meaningful. Approval would create a more accessible oncolytic immunotherapy option, but regulators remain divided over whether the single-arm IGNYTE trial reliably proves RP1’s contribution.
The FDA is clarifying when one rigorous pivotal trial supported by confirmatory evidence may establish a drug’s effectiveness. The approach could shorten development in rare diseases and precision medicine, but it does not turn small, uncontrolled or statistically fragile studies into approval-ready evidence.
Scholar Rock shifts apitegromab’s FDA review to a second fill-finish site as its September 30 SMA decision date remains on track.