This clearance is supported by compelling long-term clinical evidence from an Institutional Review Board (IRB) approved multicenter study evaluating long-term surgical safety and efficacy...
Shift from legacy IAM strengthens operational continuity and supports billions of secure healthcare transactions...
The Xpert Hemorrhagic Fever panel will support decentralised molecular testing during the Ebola Bundibugyo outbreak in DRC and Uganda....
The THUNDERBOLT platform expands Penumbra’s computer-assisted vacuum thrombectomy technology into acute ischemic stroke care....
The clearance supports decentralized urine sample collection for molecular STI testing using Roche’s cobas platforms....
The technology has demonstrated successful light transmission through tissue-mimicking models and represents a significant step toward more precise, patient-friendly cancer treatment...
The Ejection Fraction AI tool is designed to support real-time cardiac assessment in primary care and emergency settings....
The sensor expands Glean into wireless, catheter-free multi-channel urodynamics, targeting more comfortable and real-world bladder function testing. ...
The FDA-cleared update adds spleen stiffness assessment, real-time elastography imaging and EHR connectivity, strengthening Hepatoscope’s role in point-of-care liver care. ...
The next-generation platform extends handheld robotic assistance across knee and shoulder arthroplasty, supporting use in both hospital and ambulatory surgery centre settings. ...
