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. Read More
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. Read More
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. Read More
The U.S.FDA posted two warning letters to medical device manufacturers June 6, one each to Irhythm Technologies Inc., and Steiner Biotechnology LLC, and both warnings include citations for marketing for claims that are not in the FDA-reviewed product labels. Read More
The U.S. CMS has wrapped up a coverage analysis for seat elevation systems that are accessories for power wheelchairs, but the agency went above and beyond the strict terms laid out in the proposed decision memo. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Bone Biologics, Dermtech, Lamed, Nordic Nanovector, Precision Neuroscience , Prenosis, Spectronrx, Sqi Diagnostics, RLS, T2 Biosystems, Translumina. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Teleflex. Read More
