Philips Corrects Outpatient Monitoring Software Over Missed ECG Alerts
The correction addresses a software issue in the Monitoring Service Application that led to missed ECG data and notifications, potentially impacting patient care.
Tag: FDA
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Medicare to Cover Wegovy for Patients at High Cardiovascular Risk
The Centers for Medicare and Medicaid Services announced that it would allow health plans under Medicare Part D to cover Wegovy and other weight-loss medications if they receive FDA approval for an additional medically accepted indication.
FDA Greenlights Drug-Coated Balloon for In-Stent Restenosis
The FDA approves Boston Scientific Corporation’s AGENT Drug-Coated Balloon for treating coronary in-stent restenosis, marking the first drug-coated coronary balloon approval in the United States.
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FDA Awards Breakthrough Designation to Pi-Cardia’s ShortCut Catheter
ShortCut is the first dedicated leaflet modification device to enable TAVR in patients at risk of coronary obstruction, according to Pi-Cardia.
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Getinge ECMO Device Recalled Due to Critical Malfunction Risks
Getinge is recalling the Cardiohelp Emergency Drive due to possible blocking or impairment of the emergency drive’s cranking ability.
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FDA Approves Medtronic’s Renal Denervation System for Hypertension
The FDA has approved Medtronic’s Symplicity Spyral renal denervation system for the treatment of hypertension.
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FDA Grants Breakthrough Status to AI System Predicting Heart Risk from Eye Exams
The FDA has granted Breakthrough Device designation to CLAiR, an AI-driven platform that uses images from routine eye exams to non-invasively assess and predict cardiovascular disease risk.
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FDA Recommends Alternative Testing Methods for Quidel’s Triage Cardiac Panel
The FDA cautions health providers to stop using the Quidel Triage Cardiac Panel due to potential inaccuracies in troponin levels. Alternatives are recommended to ensure accurate diagnoses for myocardial infarction.
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Medtronic Issues Class I Recall for Implantable Cardioverter Defibrillators and CRT-Ds
Medtronic has issued a Class I recall for certain implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators. The recall affects hundreds of thousands of devices with potential energy output issues during high voltage therapy.
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FDA Revises Guidance on Paclitaxel-Coated Devices for Peripheral Arterial Disease Treatment
The FDA updates its guidance on paclitaxel-coated devices used in peripheral arterial disease treatment, stating no excess mortality risk is supported by updated trial data. This revision marks a significant milestone in ensuring patient safety and expanding treatment options.
Read MoreAccurKardia’s Automated ECG Analysis System Receives FDA Clearance
AccurKardia’s cloud-based AccurECG analysis system receives FDA clearance, allowing rapid and precise detection of 13 heart rhythms. This advancement in remote cardiac care brings specialist-level ECG interpretation to underserved communities and enhances workflow efficiency for clinical practitioners.
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