SurGenTec gets FDA nod for lumbar facet fixation system

Regulatory Approvals
SurGenTec has received FDA clearance for its ION-L lumbar facet fixation system for patients with degenerative disc disease (DDD) affecting the L3 to S1 levels who have not responded to conservative treatment. Designed for posterior...

SurGenTec gets FDA nod for lumbar facet fixation system

Regulatory Approvals
SurGenTec has received FDA clearance for its ION-L lumbar facet fixation system for patients with degenerative disc disease (DDD) affecting the L3 to S1...

UNEEG Medical announces FDA 510(k) clearance for UNEEG EpiSight System

Regulatory Approvals
UNEEG Medical has received FDA 510(k) clearance for its UNEEG EpiSight System, a minimally invasive implant designed for continuous, long-term EEG monitoring in patients...

Raydiant Oximetry completes enrollment of First 15 Patients in IDE Pilot Study

Clinical Trials
Raydiant Oximetry has completed enrollment and data collection for the first 15 patients in its FDA-approved IDE pilot study at LSU Health Shreveport, advancing...

Spectrum Vascular acquires catheter guidance tech developer Piccolo Medical

Mergers & Acquisitions
Spectrum Vascular has acquired Piccolo Medical, a developer of FDA-cleared catheter guidance technology, in a move aimed at strengthening its vascular access offerings. The acquisition...

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Raydiant Oximetry completes enrollment of First 15 Patients in IDE Pilot Study

Raydiant Oximetry has completed enrollment and data collection for the first 15 patients in its FDA-approved IDE pilot study at LSU Health Shreveport, advancing...

Airiver treats first patient in drug-coated balloon study for chronic rhinosinusitis

Airiver Medical has announced the first patient treatment in its RESTORE-2 pivotal clinical trial evaluating its ESSpand drug-coated balloon (DCB) for chronic rhinosinusitis (CRS). The...

Anteris to expand global heart valve trial

Anteris Technologies announced that it received full regulatory clearance to expand its PARADIGM trial to France. The company - founded in Brisbane, Australia with a...

Neuronoff implants first patient in DOD-funded trial of Injectrode

Neuronoff, a clinical-stage neuromodulation company, announced the first patient implant in a Department of Defense (DOD) funded clinical trial evaluating the safety and efficacy...

Innovation

Regulatory Approvals

SurGenTec gets FDA nod for lumbar facet fixation system

SurGenTec has received FDA clearance for its ION-L lumbar facet fixation system for patients with degenerative disc disease (DDD) affecting the L3 to S1...

UNEEG Medical announces FDA 510(k) clearance for UNEEG EpiSight System

UNEEG Medical has received FDA 510(k) clearance for its UNEEG EpiSight System, a minimally invasive implant designed for continuous, long-term EEG monitoring in patients...

Raydiant Oximetry completes enrollment of First 15 Patients in IDE Pilot Study

Raydiant Oximetry has completed enrollment and data collection for the first 15 patients in its FDA-approved IDE pilot study at LSU Health Shreveport, advancing...

Spectrum Vascular acquires catheter guidance tech developer Piccolo Medical

Spectrum Vascular has acquired Piccolo Medical, a developer of FDA-cleared catheter guidance technology, in a move aimed at strengthening its vascular access offerings. The acquisition...

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