Lush vegetation is great for a gardener, but alarming for a cardiologist. For them, the news that Angiodynamics Inc. received U.S. FDA breakthrough device designation for its Angiovac system to remove vegetation from the right heart is surely cheering. Right heart vegetations--masses of fibrin, platelets and infectious pathogens--are indications of serious infective endocarditis. Read More
The U.S. FDA’s position on predetermined change control protocols (PCCPs) is still in draft form, even though at least one company has won a marketing authorization with a PCCP attached to the underlying artificial intelligence (AI) algorithm. While the agency is still on the fence about a PCCP that incorporates a potential change in the indication for use, regulatory attorney Brigid DeCoursey Bondoc told BioWorld that industry should not reflexively avoid proposing a PCCP with a such change so long as the proposal includes answers to the questions the FDA is sure to ask. Read More
The U.S. Centers for Medicare & Medicaid Services has proposed to terminate the coverage with evidence development requirement for the use of positron-emission tomography (PET) imaging for patients suspected of suffering from beta amyloids, a marker of Alzheimer’s disease (AD). However, CMS is also considering a removal of the coverage policy that limits each patient to a single PET scan per lifetime, although the proposal to allow Medicare administrative contractors (MACs) to determine coverage is drawing fire from industry and physician groups alike. Read More
Broncus Holding Corp. successfully completed a clinical study of the world’s first transbronchial radiofrequency ablation system for lung cancer treatment. Read More
Acorai AB received a U.S. FDA breakthrough device designation for its Heart Monitor, a noninvasive intracardiac pressure monitoring device for patients with heart failure. The Acorai Heart Monitor can estimate diastolic pulmonary artery pressure, systolic pulmonary artery pressure and mean pulmonary artery pressure in patients with Stage C heart failure who have been referred for hemodynamic monitoring. Read More
Neckepur SAS signed a licensing agreement with Assistance Publique-Hôpitaux de Paris (AP-HP) to develop an in vitro diagnostic technology to optimize the medical devices used in extracorporeal circulation. The agreement covers the rights to use a patent for a method of evaluating and optimizing the doses of drugs administered to patients admitted to the intensive care unit (ICU) who are undergoing treatment with devices such as hemofiltration, extracorporeal membrane oxygenation (ECMO), continuous hemodiafiltration, and adsorbent column circuits. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Curative, Helius, Mediwound, Mölnlycke, Natera, Sectra, Sensible Diagnostics, Thirdeye. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Angiodynamics, Cathvision, Tampro, Welldoc. Read More
