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TigerConnect Secures FDA 510(k) Clearance for Industry’s First Cloud-Native Alarm Management Solution

9 October 2025
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SANTA MONICA, CA, Oct. 07, 2025 (GLOBE NEWSWIRE) -- TigerConnect, the leading unifed healthcare communications platform, today announced they have received 510(k) clearance from the FDA for TigerConnect Alarm Management, marking a pivotal milestone as the industry’s first FDA-cleared, cloud-native alarm management solution. With this offering, hospitals can now combat alarm fatigue and support patient safety initiatives with a modern, scalable solution that ensures critical alarms from patient monitors, infusion pumps and ventilators are never missed — while delivering the flexibility and resilience today’s healthcare demands. 

With 80%+ of bedside alarms being non-actionable, nurses are overwhelmed by noise, making it harder to distinguish true priorities — fueling alarm fatigue, desensitization and the risk of missing critical events. TigerConnect Alarm Management addresses this omnipresent problem by routing alerts for actionable patient events to the right caregiver, at the right time, with the right context — with sophisticated fail-safes to help ensure patient safety.     The solution is built on top of TigerConnect CareConduit, a cloud-native, intelligent workflow automation platform that seamlessly integrates data from disparate hospital technologies —  EHRs, nurse call systems, virtual nursing solutions and beyond — to unify healthcare communications and drive system-wide efficiency. By unlocking siloed data and intelligently orchestrating workflows across the care continuum such as consults, critical labs, bedside alarms and more, CareConduit diminishes cognitive burden for care teams, reduces care delays and enhances quality of care and patient outcomes. 

“FDA clearance for TigerConnect Alarm Management, the industry’s first cloud-native alarm management solution, represents a critical step forward in enabling hospitals to deliver safer, highly reliable care,” said Saurin Shah, Chief Product Officer at TigerConnect. “By centralizing actionable alerts for front-line clinicians, we can help reduce alarm fatigue, prevent missed or delayed interventions and support a culture of patient safety — empowering care teams to focus on what matters most.” 

Traditional alarm management solutions require extensive on-premises infrastructure, VPNs and IT support to deploy and maintain. TigerConnect Alarm Management, built on AWS, eliminates these burdens by providing a secure, fully managed service with upgrades, monitoring and troubleshooting handled in the cloud — making the solution accessible for hospitals of all sizes. 

As part of the FDA clearance process, TigerConnect underwent a rigorous cybersecurity risk assessment that tested resilience against real-world attacks, encryption strength and safeguards to protect patient data across hospital networks. Security is embedded into TigerConnect Alarm Management by design, ensuring clinicians can rely on the solution without introducing new vulnerabilities.  

Read the full press release here.

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