The French national authority for health (HAS) has provisionally set up CEDiag, a committee for assessing diagnostic, prognostic or predictive health technologies. This new national committee will cover the field of clinical procedures, including radiology, clinical biology and anatomo-cytopathology examinations, diagnostic drugs such as contrast agents used in medical imaging and radiopharmaceutical drugs, as well as medical devices such as self-testing kits.
The U.S. FDA has given the greenlight to Sparrow Acoustics Inc. (dba Sparrow Bioacoustics) for its Stethophone, a software-based technology that allows doctors and nurses to check a patient’s heart and lung sounds using a smartphone. Providers simply hold the smartphone against the patient’s chest to listen for possible abnormalities.
Conformal Medical Inc. plugged the gap in funding needed to complete enrollment in the pivotal CONFORM trial for its left atrial appendage occlusion (LAAO) technology with completion of an oversubscribed $35 million series D fundraising round. The Conformal left atrial appendage seal (CLAAS) system is designed to close off the left atrial appendage in individuals with non-valvular atrial fibrillation to cut the risk of stroke and avoid the use of anticoagulants.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Advanced Medical Solutions, Artelon, Avatar Medical, Deepx Diagnostics.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Accustem, Artoss, Biocomposites, Detect-Ion, Gore, General Graphene, GE Healthcare, Graphenedx, Ixlayer, Masimo, Pathmaker Neurosystems, Porter, Sapphiros.
There is a growing body of evidence showing prescription digital therapeutics (DTx) are effective, but slow progress in agreeing reimbursement and integrating them into care pathways is limiting access for patients and holding back commercial development in Europe.
Breakthroughs in early detection of cancer offer increasing hope for better outcomes and longer lives for individuals affected by malignancies. This year’s American Society of Clinical Oncology annual meeting highlighted strong results from several companies at the forefront of this potential transformation.