Some U.S. FDA inspections go better than other ones, but the agency’s inspection of the Boston plant operated by a subsidiary of Princeton, N.J.-based Integra Lifesiences Holding Corp. was not one of those with a quick resolution. The agency said in a July 17 warning letter that Integra will have to obtain certification for the site in each of the next three years after finding considerable fault with operations, including one citation the agency said is a carryover from a warning letter issued in 2019.
Cathvision ApS received U.S. FDA clearance for two artificial intelligence (AI) models, the PVI Analyzer, and Signal Complexity, which are part of a suite of algorithms designed to help electrophysiologists improve the diagnosis and treatment of complex atrial arrhythmias, including atrial fibrillation. The two algorithms are part of Cathvision’s Cardialytics suite of AI-powered analytics integrated into its Ecgenius system, an electrophysiology recording system that helps with electrogram interpretation.
The U.S. FDA granted the de novo marketing request for Bluewind Medical Ltd.’s Revi system for the treatment of urgency incontinence with or without urinary urgency, the company reported on August 17. Unlike other neuromodulation devices approved in recent years, Revi stimulates the tibial nerve instead of the sacral nerves.
It’s been 25 years since the U.S. FDA issued a final guidance on informed consent and nine years since it asked for comments on a draft guidance to supersede that 1998 guide.
Fractyl Health Inc. reported clinical updates on the Revita real world registry in Germany which has demonstrated clinical remission from type 2 diabetes (T2D) employing a device that resurfaces the duodenal mucosa, the innermost layer of the first portion of the small intestine, and a potential root cause of T2D.
Hypertrophic cardiomyopathy (HCM) might not be the talk of the town in the world of cardiology medical devices, but the condition has a devastating effect on a large number of lives, particularly in the case of early disease onset. San Francisco-based Viz.ai Inc. has won a de novo from the U.S. FDA for its algorithm for identification of patients at risk of HCM, the aptly named Viz HCM, a product the company believes will not only save lives but may save the U.S. health care system a large amount of money as well.
Bruker Corp. signed a definitive agreement to acquire functional cell biology company Phenomex for $108 million as part of its Project Accelerate 2.0 strategy, which increases focus on the company’s emerging proteomics and spatial biology business. Bruker offered $1 per share, a 150% premium over the 40 cents per share closing price of Phenomex stock on Aug. 16. The all-cash transaction is slated to close in the fourth quarter of 2023.
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.
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.
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.
RSS
