| The Month in Review | Specific lots of a popular ACE inhibitor are being recalled after a sample produced an out-of-specification test result. The FDA categorized this issue as a Class II recall. Specific lots of a popular ACE inhibitor are being recalled after a sample produced an out-of-specification test result. The FDA categorized this issue as a Class II recall. | | |
| After months of consideration, CMS has officially signed off on major changes to its TAVR policies. The treatment of asymptomatic patients is now covered by Medicare, for example, and fewer reporting requirements are in place when symptomatic patients undergo treatment. After months of consideration, CMS has officially signed off on major changes to its TAVR policies. The treatment of asymptomatic patients is now covered by Medicare, for example, and fewer reporting requirements are in place when symptomatic patients undergo treatment. | | |
| The advanced algorithm, built to detect STEMI and STEMI-equivalent patterns in ECG results, gained the FDA's breakthrough device designation back in 2025. The advanced algorithm, built to detect STEMI and STEMI-equivalent patterns in ECG results, gained the FDA's breakthrough device designation back in 2025. | | |
| This latest alert comes after Johnson & Johnson MedTech found that certain devices may require hardware, firmware and/or software updates to address safety concerns. This latest alert comes after Johnson & Johnson MedTech found that certain devices may require hardware, firmware and/or software updates to address safety concerns. | | |
| If a malfunction does occur, Stryker warned, it could impact the device's effectiveness. No adverse events have been reported at this time. If a malfunction does occur, Stryker warned, it could impact the device's effectiveness. No adverse events have been reported at this time. | | |
| Xylitol, a sugar substitute found in chewing gum, baked goods and toothpaste, was associated with long-term cardiovascular risks in a new study of more than 17,000 adults. Xylitol, a sugar substitute found in chewing gum, baked goods and toothpaste, was associated with long-term cardiovascular risks in a new study of more than 17,000 adults. | | |
| The newly approved device is 14% shorter than the previous version and gives clinicians more options when making implant decisions. The newly approved device is 14% shorter than the previous version and gives clinicians more options when making implant decisions. | | |
| The new ASNC document includes detailed SPECT- and PET-specific protocols, patient preparation recommendations and a fresh look at safety. The new ASNC document includes detailed SPECT- and PET-specific protocols, patient preparation recommendations and a fresh look at safety. | | |
| Pelacarsen, an investigational heart drug developed by Novartis, did successfully reduce Lp(a) levels in high-risk heart patients. However, it was unable to reduce the risk of major adverse cardiovascular events among those patients. Pelacarsen, an investigational heart drug developed by Novartis, did successfully reduce Lp(a) levels in high-risk heart patients. However, it was unable to reduce the risk of major adverse cardiovascular events among those patients. | | |
| Johnson & Johnson is selling key assets related to its Laminar program to a new startup, Jaguar LAA. This comes less than three years after Johnson & Johnson acquired Laminar for $400 million. Johnson & Johnson is selling key assets related to its Laminar program to a new startup, Jaguar LAA. This comes less than three years after Johnson & Johnson acquired Laminar for $400 million. | | |
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