Digital twins and model-informed drug development are moving from research concepts toward regulatory infrastructure, raising the possibility that future pharmaceutical trials could use simulated patients to refine doses, predict outcomes and potentially reduce the number of people required in selected control groups.
Final MARRS pivotal-trial results show Perfuze’s FDA-cleared Millipede88 aspiration catheter achieved 89% successful reperfusion without rescue therapy and a 75% first-pass effect in M1 middle cerebral artery occlusions.
The EFICAS study of the Aeson Total Artificial Heart achieved its primary endpoint in 72.7% of 55 severely ill patients, with 96% remaining free of disabling stroke at 180 days and 76% discharged from hospital.
PharmaEssentia has secured FDA approval for BESREMi in adults with essential thrombocythemia after the Phase 3 SURPASS ET trial showed a 37.4% durable response rate versus 3.6% with anagrelide.
Ascletis Pharma has dosed the first participant in a 4,600-person global Phase 3 program for ASC30, a once-daily oral small-molecule GLP-1 receptor agonist that produced up to 7.7% placebo-adjusted weight loss after 13 weeks in Phase 2.
Cardiovolt.ai and Imperial College London researchers are developing artificial intelligence capable of extracting hidden signals for heart failure, valve disease and other conditions from routine ECGs, raising the possibility that one of medicine’s oldest tests could become a far broader screening platform.
The FDA is warning patients who received mammograms at Mammography Center of Monterey on or after December 22, 2023 about possible image-quality problems after the facility failed an additional review and some deficiencies were classified as severe.
GE HealthCare’s Photonova Spectra has secured CE Mark after earlier U.S. FDA clearance and Japanese approval, accelerating the global expansion of photon-counting CT technology that promises higher-resolution and spectral imaging from individual X-ray photons.
A prespecified VESALIUS-CV analysis found a 20% reduction in mortality with Amgen’s Repatha among more than 12,000 high-risk adults without a previous heart attack or stroke, strengthening the case for intensive LDL lowering before the first major cardiovascular event.
A new real-world study of sustained low-dose semaglutide and tirzepatide found measurable weight loss without escalation to standard maintenance doses, but researchers stress that prescription records do not prove intentional GLP-1 microdosing and the observational findings cannot establish cause and effect.