FDA clears Corvention’s KardiaPSI Balloon Catheter as structural heart tools get more specialized
Calcified aortic valves need force and control. Corvention’s KardiaPSI clearance tests whether niche BAV tools can scale clinically.
How Rivanna’s Accuro XV could change hospital imaging workflows after FDA clearance
X-rays dominate fracture triage. Rivanna’s FDA-cleared Accuro XV tests whether ultrasound can move closer to the front line.
Can ZETA SURGICAL turn brain biopsy and hydrocephalus procedures into point-of-care care?
Neurosurgery needs precision beyond elite hospitals. ZETA SURGICAL’s FDA clearance puts AI-guided access to the real-world test.
Why 3Shape’s Dx Software clearance matters for digital dentistry’s next phase
Dental AI is moving from scan capture to diagnosis support. 3Shape Dx now faces the harder test of U.S. clinician adoption.
FDA clears Olympus POWERSEAL Open Extended Jaw as surgical energy competition grows
Olympus cleared a new POWERSEAL device, but adoption now depends on surgeon trust, hospital value reviews, and open surgery workflow gains.
Is EASYMADE TI the breakthrough CGBIO needs in patient-specific craniofacial reconstruction?
Customized implants are moving from niche to surgical workflow. CGBIO’s U.S. clearance tests whether speed can become a medtech edge.
Vapotherm FDA clearance expands HVT 2.0 use from neonatal to adult respiratory care
Find out how Vapotherm’s FDA-cleared All Patient Circuit could simplify high velocity therapy from neonatal to adult care.
Robotic cochlear implants approved for kids: Is iotaSOFT reshaping pediatric ENT standards?
iotaMotion, Inc. has received U.S. Food and Drug Administration 510(k) clearance to expand the approved use of its iotaSOFT Robotic-Assisted Cochlear Implant Insertion System for children as young as four years old. This regulatory milestone makes the iotaSOFT system the first robotic-assisted cochlear insertion platform authorized for use in school-aged pediatric patients, expanding access to […]
BrainSpace wins FDA nod for automated brain fluid system—what this means for ICUs
BrainSpace, a U.S.-based medical technology company, has received 510(k) clearance from the U.S. Food and Drug Administration for Intellidrop, a fully automated cerebrospinal fluid (CSF) drainage and intracranial pressure (ICP) monitoring system. The cleared indication covers ventricular or lumbar use in patients requiring external CSF drainage and continuous pressure monitoring—making it potentially relevant across a […]