Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alzecure, Cornerstone, Elevation, Jaguar, Medac, Medexus, Oncotelic, Phathom, Verrica.
The mutual recognition agreement between Switzerland and the EU for medical devices lapsed in 2021, a development that was expected to add a significant amount of drag on Swiss device exports to EU nations.
Organ transplant diagnostic company Caredx Inc. has received CE marking for its Alloseq HCT chimerism testing kit and Alloseq HCT interpretation software for use in patients who have received hematopoietic cell transplantation (HCT). The NGS-based solution is used to monitor engraftment and evaluate the success of a hematopoietic stem cell transplant by measuring the relative ratio of the recipient and the donor cell population post-transplantation.
About $1.7 trillion in securities of China-based issuers listed on U.S. exchanges could face trading prohibitions in as little as two years, Y.J. Fischer, director of the U.S. SEC’s Office of International Affairs, warned during remarks at the May 24 annual meeting of the International Council of Securities Associations.
The U.S. FDA has rejected Verrica Pharmaceuticals Inc.’s drug-device combination to treat the viral skin disease molluscum for a third time, losing more ground to a potential rival from Novan Inc., because of continued manufacturing issues. There are no FDA-approved treatments for molluscum contagiosum, which leads to skin-colored or pink lesions and affects around 6 million people in the U.S. annually.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Angle, Centogene, Genomic Testing Cooperative, Hologic, Seekin.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alpine, Antios, Assembly, Blue Lake, Ceruvia, CSL, Dermavant, ENB, Immune, Merck & Co., Neuronascent, Noveome, Ocugen, Roche, Synlogic, United, Xcovery.
Those who are burdened with Marfan syndrome face a lifetime of multi-organ system issues including potential aortic aneurysm, but help may be on the way in the U.K. The National Institute of Health and Care Excellence (NICE) has issued a recommendation that these patients be treated with personalized external aortic root support (PEARS) to treat both aortic root expansion and aortic dissection, although the agency indicated that this procedure is not quite ready for routine use in the National Health Service.
The U.S. FDA’s proposal to restructure the Quality System Regulation (QSR) with ISO 13485, the international quality system standard, is a major shift for affected industry, but there are strictly administrative issues associated with this proposal. Several of those who have commented to the docket have expressed misgivings as to the proposed 12-month compliance deadline upon issuance of a final rule.
The transformation of cardiology continues with two U.S. FDA actions to promote the use of artificial intelligence (AI): a 510(k) clearance for Rapidai Inc.’s pulmonary embolism (PE) triage and notification product and breakthrough device designation for Anumana Inc.’s pulmonary hypertension (PH) early detection algorithm.
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