FDA announces Class 1 recalls for ventilator software, electrode pads
Editor's Note The US Food and Drug Administration (FDA) has classified recalls by Hamilton Medical and Megadyne as Class 1 events, the most severe category indicating risk of serious injury or death. According to the agency’s July 11 report, Hamilton Medical is correcting software for its HAMILTON-C6 Medical Ventilator to…
FDA announces Class 1 recalls for upper airway stimulation system, MRI components
Editor's Note A manufacturing defect in a critical component of an upper airway stimulation (UAS) system and coils prone to overheating during magnetic resonance imaging scans (MRIs) prompted The US Food & Drug administration to issue two Class 1 recalls June 8. Class 1 is the most severe category, indicating…
Healthcare industry groups criticize federal cybersecurity reporting rule
Editor's Note Healthcare industry groups are calling for the federal government to streamline and ease the recently proposed cybersecurity incident reporting rule by the Cybersecurity and Infrastructure Security Agency (CISA), Fierce Healthcare reported July 8. According to the report, CISA's proposal imposes enhanced reporting requirements for critical infrastructure entities, including…
Healthcare cybersecurity earns B+, but vulnerabilities remain
Editor's Note Although SecurityScorecard gave the US healthcare a “better than expected” B+ rating for cybersecurity in 2024, the supply chain cybersecurity firm also highlighted significant risks in application and endpoint security, HealthcareIT News reported June 25. Overall, 35% of third-party data breaches in 2023 affected healthcare organizations, the…
FDA issues Class 1 recalls for two ventilator models
Editor's Note Alarm failures and missing details in instructional materials prompted the US Food and Drug Administration (FDA) to issue class 1 recalls—the most severe category indicating risk of serious injury or death—for two different ventilator models on June 27. According to the report, failure in the Ventilator Inoperative alarm…
Post-CABG cardiac shockwave therapy shows promise in early study
Editor's Note Using a device they call a “space hairdryer,” researchers in Austria applied gentle shockwaves to regenerate heart tissue after coronary artery bypass graft surgery (CABG) in a study with potential implications for millions of patients, BBC News reported June 20. Researchers are now seeking larger trials, European regulatory…
AI outperforms radiologists in detecting clinically significant prostate cancer
Editor's Note In a recent study, an artificial intelligence (AI) system detected more clinically significant prostate cancers and fewer indolent cancers than human radiologists reading MRIs, MedPage today reported June 13. The MedPage report covers a study published in Lancet Oncology that, according to researchers, “provided evidence that AI systems,…
FBI, HHS issue healthcare cybersecurity warning
Editor's Note A June 24 advisory from the FBI and Department of Health and Human Services warns healthcare organizations about attempts to steal payments through phishing and social engineering tactics, according to a post from the American Hospital Association (AHA). The attackers target employee email accounts to access login information…
Russian ransomware group threatens cybersecurity beyond London attack
Editor's Note Qilin, a ransomware group based in Russia, claimed responsibility for a cyberattack against pathology services provider Synnovis that paralyzed London Hospitals and is now requesting $50 million, Becker’s Health IT reported June 20. Citing a report from Bloomberg, the article notes that the attack disrupted services at London-based hospitals…
Change Healthcare issues notifications of patient data stolen in cyberattack
Editor's Note Change Healthcare has started to notify health care providers about patient data stolen in the February cyberattack and announced plans to mail affected individuals as well. A unit of UnitedHealth Group, the organization issued the update June 20. “CHC is providing this notice now to help individuals understand…
Free Daily News
- Study: ERAS protocol reduces opioid use after cardiac surgery
- Study: Prehabilitation reduces surgical complications, speeds recovery
- Commentary: Studies show how surgeon decisions follow the money
- Proposed HIPAA updates would improve cybersecurity, increase costs for healthcare providers
- Study: EMR data can enhance hand hygiene compliance, infection prevention
- Study: Machine learning model improves perioperative pain assessment
- Call for improved suicide risk screening in ASCs aims to strengthen safety protocols
- Study: Perioperative pregabalin reduces risk of kidney decline compared to gabapentin
- Medical school diversity declines after Supreme Court ruling
- Surgeons risk losing ground as transcatheter tricuspid valve interventions rise