The prospective NEURO PMR study found 92% blinded concordance between portable and conventional brain MRI, rising to 98% after clinical review, as Hyperfine reports more than 3,000 office scans.
PENTAX Medical will integrate and distribute MAGENTIQ-COLO across the US, EMEA, JAPAC and Latin America after randomized evidence showed higher adenoma detection and a lower miss rate than conventional colonoscopy.
MolDX coverage now includes RaDaR ST for monitoring immune-checkpoint inhibitor response in late-stage solid tumors, expanding reimbursement while current ASCO guidance still treats ctDNA as complementary rather than a replacement for standard assessment.
Masimo’s FDA-cleared Root with LiDCO combines cardiac output, SpHb and oxygen saturation to continuously trend calculated oxygen delivery during major surgery and other periods of physiological stress.
Libre Duo 10 Day continuously measures glucose and ketones every minute for people with diabetes aged two and older, creating the first US integrated glucose-ketone monitoring category.
CooperSurgical’s new Wallace Aspiration Pump uses digital pressure control and two preset settings designed around different retrieval needles, targeting consistency during a critical IVF procedure.
Tempus ECG-PH analyzes routine 12-lead ECGs from symptomatic adults aged 40 and older and returns a binary signal associated with elevated pulmonary artery pressure, but it is not a stand-alone diagnosis.
A new US patent allowance broadens protection around RenovoRx’s dual-occlusion drug-delivery catheter as commercial revenue grows and the separate TIGeR-PaC drug-device programme moves toward 2027 data.
FDA has cleared Freyja Healthcare’s second-generation VereSee, combining a 2 mm miniature laparoscope with visual entry technology intended to show anatomy during initial laparoscopic access.
LSI Medience has validated Pillar’s oncoReveal Essential+ for cfDNA and cfRNA screening, with approximately 2,000 lung cancer patients expected to enter testing over two years.