GE Healthcare is recalling CARESCAPE R860 ventilator backup batteries manufactured on or after April 1, 2019, because the batteries may run out before they are expected to do so.
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 Alerts for June 23, 2022
The U.S. Food and Drug Administration (FDA) announced device recalls.
Market Withdrawal: Rubraca for Third-Line Ovarian Cancer Indication
Clovis Oncology Inc. has announced a voluntary market withdrawal of Rubraca (rucaparib) in the U.S. as treatment of BRCA-mutated ovarian cancer after 2 or more chemotherapies. This withdrawal became effective on June 10, 2022, and does not affect other indications for Rubraca.
Ukoniq Withdrawn from Market due to Safety Concerns
The U.S. Food and Drug Administration (FDA) announced on June 1, 2022, that Ukoniq (umbralisib; TG Therapeutics Inc.) is being withdrawn from the market due to safety concerns.
FDA Update on Philips Respironics Recall
The U.S. Food and Drug Administration (FDA) has updated a safety communication on certain Philips Respironics ventilators, BiPAP machines, and CPAP machines that were recalled due to potential health risks.
FDA Safety Alert: Noninvasive Prenatal Screening Tests
The U.S. Food and Drug Administration (FDA) is warning patients and healthcare providers about the risks of false results with genetic noninvasive prenatal screening tests.
FDA Letter to Health Care Providers: Imaging Software for Intracranial Large Vessel Occlusion
The U.S. Food and Drug Administration (FDA) issued a letter to healthcare providers regarding the intended use of radiological computer-aided triage and notification (CADt) devices for intracranial large vessel occlusion (LVO).
CMS Posts Final Decision Memo on Monoclonal Antibodies for Alzheimer Disease
On April 7, 2022, the Centers for Medicare & Medicaid Services (CMS) released a final National Coverage Analysis (NCA) decision memo, Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease.
FDA News Alerts
The U.S. Food and Drug Administration (FDA) recently posted these news items.
FDA News Alerts for March 23, 2022
The U.S. Food and Drug Administration (FDA) recently posted several updates.