Ziwig SAS, which leads the race for a simple diagnostic for endometriosis, picked up the pace with a fast-track reimbursement decision in France for its Endotest, the first saliva-based diagnostic assay for endometriosis.
The U.K. Medicines and Health Care Products Regulatory Agency reported a pilot program for the use of RWE in regulatory decision making, which is largely directed toward drug products.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aeye Health, Konica Minolta, Daxor, Pelvital, Whitswell.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Cerevasc, Homeward, Humana Inc., Inspiremd, Monogram Health.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Roche, Subtle Medical.
With the first company in the world announcing more than $1 billion in annual revenue from pulsed field ablation on Feb. 5, Clarivate plc and BioWorld MedTech’s latest report provides well-timed insight into the stunning growth and bright future of this new medical technology for the treatment of atrial fibrillation.
Edwards Lifesciences Corp.’s posted fourth quarter results slightly ahead of expectations, but indicated that the first quarter of 2025 might not be as bright. The company expects growth for both its lead transcatheter aortic valve replacement (TAVR) business and the company to fall below its full-year estimates, with a mid-year indication expansion for TAVR providing a critical boost in the back half of 2025.
Biotronik Neuro’s Prospera spinal cord stimulation system achieved more than 50% pain reduction for 86% of patients with back pain and 89% of patients with leg pain over two years, according to new study results.
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