Beam Therapeutics has begun dosing in the global pivotal cohort of its BEAM-302 trial, advancing a one-time in vivo base-editing therapy that could address both lung and liver disease in people with severe alpha-1 antitrypsin deficiency.
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.
Rhythm Pharmaceuticals has reported preliminary RM-718 data showing an 11.6% mean body mass index reduction after 16 weeks in seven patients with acquired hypothalamic obesity. The small, open-label dataset supports further development but cannot yet establish how the weekly injection compares with approved daily setmelanotide.
Tempus AI’s PRISM2 foundation model matched or exceeded specialised pathology products across several retrospective cancer-detection tests while also supporting biomarker and survival predictions. The results strengthen the case for general-purpose pathology artificial intelligence, but PRISM2 is not yet an FDA-authorised diagnostic device.
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.
Neurocrine Biosciences has initiated a first-in-human Phase 1 study of NBIP-1968, a once-weekly experimental obesity treatment designed to activate the GLP-1, GIP and glucagon receptors through a single molecule. The August 7, 2026 development marks Neurocrine Biosciences’ entry into clinical testing with an incretin-based obesity candidate. The study will initially examine single ascending doses in
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.