Despite the ongoing pandemic, Acutus Medical Inc. (NASDAQ:AFIB) decided to go down the IPO route. It officially started trading today after reporting its offering of more than 8.8 million shares of its common stock at $18 per share, with expected gross proceeds of $158.8 million. Last month, the Carlsbad, Calif.-based company estimated that the IPO price per share would be between $16 and $18. Read More
Startup Conformal Medical Inc. has reeled in $85 million in a series C round to support a U.S. pivotal trial of its CLAAS technology, a device designed to seal off the heart’s left atrial appendage (LAA) to reduce the risk of stroke in patients with atrial fibrillation. The financing included participation from new investors Fidelity Management & Research Company LLC and an undisclosed strategic investor. Read More
Improving metabolic disorders without major changes in diet and exercise is typically seen as impossible, unless bariatric surgery is involved. But that’s precisely what Fractyl Laboratories Inc. aims to do. It plans to start a pivotal trial of its duodenal mucosal resurfacing system, Revita DMR, before year end. Read More
Real-world evidence (RWE) and clinical trial data might seem to bear little resemblance to each other, but Naomi Aronson, executive director for clinical evaluation at the Blue Cross and Blue Shield Association, said there are problems common to both. The most significant of these is an absence of validated outcomes measures for many conditions, measures Aronson said are “desperately” needed in order to make an appropriate coverage determination. Read More
PERTH, Australia – A review by Australia’s Therapeutic Goods Administration (TGA) revealed that medical device recall databases may significantly under-represent software errors, causing harm to patients. These under-reported events are due to patients being unaware how to report problems, inadequate information being reported, effects of software errors being too subtle or difficult to detect, or root cause analyses that may not identify software as the source of error when it causes other components to fail. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Beckman Coulter, Boston Scientific, Carmat, Veracyte. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Adaptive Biotechnologies, Cardiacsense, Joimax, Scientia Vascula, Surmodics, Vela Diagnostics. Read More
Keeping you up to date on recent developments in diagnostics, including: Facilitating analysis of scratch wound healing tests; Advanced imaging in children; Picturing molecular alterations. Read More
