Regulatory milestone supports China’s reproductive health goals by enabling radiation-free, high-accuracy ultrasound imaging to assess fallopian tube patency and uterine abnormalities in women. ...
Regulatory green light marks full commercial launch of LungVision, enhancing early lung cancer detection through AI-driven 3D imaging for more precise bronchoscopic diagnostics....
BMI OrganBank is developing novel medical devices with potential to significantly reduce the waitlist for lifesaving organ transplants, beginning with kidneys...
In April, Health Secretary Robert F. Kennedy Jr. announced plans to dramatically reduce animal testing at U.S. health agencies. The FDA followed with a commitment to phase out animal studies in areas like monoclonal antibody development, favoring in vitro systems and artificial intelligence instead. ...
Designed to detect more high-risk HPV strains than any test on the market, the BD Onclarity™ Assay empowers women with a discreet, non-invasive screening option and leverages full lab automation to ensure accuracy, efficiency, and expanded access to cervical cancer prevention. ...
Awarded for its proprietary MoRe® alloy-based 2.9 mm rod, the EUROPA® PCF System offers a low-profile, high-strength solution for cervical and upper thoracic spine surgery—now eligible for Medicare reimbursement under the New Technology Add-on Payment programme. ...
2025 Regulatory Affairs Benchmark finds half of medtech firms lack confidence in registration data quality, with most relying on manual processes—yet momentum grows for adopting automation, RIM systems, and AI to accelerate compliance and market access. ...
Reexamination finds Rampart’s radiation shielding patent lacks novelty, validating Egg Medical’s stance and bringing resolution to a legal battle that had clouded the competitive landscape....
VersaCoat, a syringe-deliverable soft-tissue protector, brings Alafair’s proven hyaluronic acid and alginate formula to complex surgical sites—expanding its impact in orthopedic, trauma, and sports medicine procedures....
Milestone underscores ClariMed’s commitment to quality excellence and reinforces its position as a trusted partner in navigating complex global regulatory landscapes ...
