On January 11, 2022, the Centers for Medicare and Medicaid Services (CMS) released a proposed decision memo, Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease, proposing to cover FDA-approved monoclonal antibodies directed against amyloid for the treatment of Alzheimer disease (AD) under Coverage with Eviden…
Hayes News
Hayes News Service keeps our clients up to date with late-breaking news from clinical trials, coverage decisions, and new product approvals. We focus on emerging technologies with potentially high clinical and financial impact as soon as they are announced publicly.
Our analysts scan more than 75 peer-reviewed journals and news briefings from government agencies, medical associations, and research institutes. Results of selected studies or articles are summarized and posted with a brief commentary on whether the findings are likely to have a substantial impact.
FDA Safety Alert: Cardiosave Hybrid and Rescue IABP
Getinge/Datascope/Maquet is recalling Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump (IABP) due to complaints of fluid leaks.
FDA Safety Alert: Cardiosave Hybrid/Rescue Intra-Aortic Balloon Pump Battery Packs
The Food and Drug Administration (FDA) has announced a recall of Cardiosave Hybrid/Rescue Intra-Aortic Balloon Pump Battery Packs (Datascope/Getinge/Maquet) due to the risk of the battery failing and having a shortened run time.
FDA Safety Alert: Zimmer Biomet ROSA One 3.1 Brain Application
The Food and Drug Administration (FDA) has announced a recall of the ROSA One 3.1 Brain Application (Zimmer Biomet) due to a software error that could lead to incorrect placement of instruments during stereotactic neurosurgical procedures.
FDA Safety Alerts
The Food and Drug Administration (FDA) recently issued the following safety alerts.
FDA Updates Boxed Warnings for Three JAK Inhibitor Labels
The Food and Drug Administration (FDA) is requiring new and updated warnings for Janus kinase (JAK) inhibitors Xeljanz/Xeljanz XR (tofacitinib; Pfizer), Olumiant (baricitinib; Eli Lilly and Co.), and Rinvoq (upadacitinib; AbbVie Inc).
FDA Safety Alert: Boston Scientific INGENIO Pacemakers and CRT-Ps
The Food and Drug Administration (FDA) has announced a recall of the INGENIO pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps; Boston Scientific) due to the risk of incorrect transition to safety mode.
FDA Safety Alert: Pepaxto
The Food and Drug Administration (FDA) issued a safety alert for Pepaxto (melphalan flufenamide; Oncopeptides AB) based on results from the OCEAN trial, which demonstrated an increased risk of death.
First FDA Approval Based on Real World Evidence
On July 16, the Food and Drug Administration (FDA) approved a new indication for Prograf (tacrolimus; Astellas Pharma US Inc.) based on observational study data providing real-world evidence (RWE) of effectiveness. It is the first drug approval based on RWE. The newly approved indication is for use in combination with other immunosuppressant drugs to prevent organ rejection i…
FDA Safety Alert: NuVasive MAGEC Devices
The Food and Drug Administration (FDA) issued a safety communication regarding potential mechanical failures and concerns about biocompatibility associated with components of the following NuVasive Specialized Orthopedics MAGEC devices: