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.
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.
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25 years since the U.S. FDA issued a final guidance on informed consent and nine years since it asked for comments on a draft guidance to supersede that 1998 guide.
Often when the U.S. FDA’s Office of Prescription Drug Promotion (OPDP) determines that the marketing of a drug crosses the line of misbranding, it hands the sponsor an untitled letter schooling it on how the promotional materials run afoul on safety or efficacy claims.
A recent bipartisan request for funding of a study on replacing U.S. drug patents with cash prizes is just one more symptom of a larger global malady that makes patents the scapegoat for bigger problems that have nothing to do with intellectual property (IP), David Kappos, board co-chair of the Council for Innovation Promotion (C4IP), told BioWorld.
The Biden administration recently announced an extension of the comment period for a request for information on harmonization of cybersecurity regulation, a proposal that could conflict with FDA regulation of medical device cybersecurity.
Delcath Systems Inc. reported that the FDA approved its Hepzato Kit for the treatment of adults with unresectable hepatic-dominant metastatic uveal melanoma (mUM). The FDA nod also triggered a second tranche of financing of approximately $35 million from a private placement in March.
Boston Scientific Corp. has managed its Polarx device to another regulatory approval, this time a nod from the U.S. FDA, giving the company access to one of the world's premier markets. The news comes four months after the company obtained a CE mark for the device, opening the door to two jumbo markets in a move the company hopes will ensure the device will provide solid returns on its investment.
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