The U.S. FDA’s recent warning letter to Danvers, Mass.-based Abiomed Inc., may have come across as an enforcement outlier in the context of the agency’s controversial final guidance for clinical decision support (CDS) products.
The unique device identifier (UDI) might not be the most exciting U.S. FDA enforcement mandate for most of regulated industry, but the FDA’s Keisha Thomas indicated that compliance is less than adequate in the agency’s view.
The COVID-19 pandemic took a huge bite out of the U.S. FDA’s ability to conduct inspections in a timely manner, but the FDA’s Douglas Stearn said the agency has nonetheless ramped up these activities.
Artificial Intelligence (AI) driven tools have the ability to design new drugs, with a bit of help from humans, said Anders Hogner, from Astrazeneca plc’s R&D department at the Bio-IT World Conference & Expo Europe in London. “We don’t have anything out there yet,” he added, but the company appears to be working on it.
Surmodics Inc. reported positive two-year data from the SWING trial, the first-in-human study to look at the safety of its Sundance Sirolimus drug-coated balloon (DCB) when used to treat occlusive disease of the infrapopliteal arteries. Results presented at the VEITHsymposium in New York showed that the Sundance Sirolimus DCB demonstrated an excellent safety profile and achieved primary patency of 71.4% at 24 months in the per protocol analysis population.
One-year data from Xeltis AG’s first-in-human Axess vascular conduit trial showed outstanding results in patients with end stage renal disease who were deemed unsuitable for arteriovenous (AV) fistula creation. The results, presented at the VEITHsymposium in New York, showed 100% secondary patency, 78% primary assisted patency and no infections were observed in data from 20 patients implanted with the Axess conduit.
Siemens Healthineers AG appears to be committed to its Diagnostics business after Jochen Schmitz, CFO, pushed back at rumors speculating that the German company was looking at options for the underperforming segment, including a sale.
Senior leaders and investors in the health care sector expect mergers and acquisitions (M&A) activity to continue to pick up next year but this will be corporate led rather than private equity, according to a report by global investment bank Jefferies. At the same time, many executives remained concerned about the lack of funding in the sector as it was identified as the number one threat.
One-year results from the CLASP IID trial and registry showed outstanding results in patients with significant symptomatic degenerative mitral regurgitation (DMR) for Pascal, Edwards Lifesciences Corp.’s transcatheter-edge-to-edge repair (TEER) system, in a presentation at the 2023 Transcatheter Cardiovascular Therapeutics (TCT) meeting in San Francisco hosted by the Cardiovascular Research Foundation.
Left atrial appendage (LAA) occlusion procedures are designed to reduce the risk of thromboembolism in patients who have non-valvular atrial fibrillation, but a study presented at the 2023 Transcatheter Cardiovascular Therapeutics annual meeting in San Francisco demonstrated that about half of patients continue to have LAA leaks – and potentially the risk of dangerous blood clots and stroke – a year after the procedure.