Bioness wins FDA clearance for portable neurostimulator for stroke recovery

Regulatory Approvals
Bioness Medical has received FDA 510(k) clearance for its PoNS (Portable Neuromodulation Stimulator) system to treat dynamic gait deficit caused by chronic stroke symptoms. This regulatory milestone significantly expands the commercial indications for the...

Bioness wins FDA clearance for portable neurostimulator for stroke recovery

Regulatory Approvals
Bioness Medical has received FDA 510(k) clearance for its PoNS (Portable Neuromodulation Stimulator) system to treat dynamic gait deficit caused by chronic stroke symptoms....

United Therapeutics gets FDA green light for lung perfusion device

Regulatory Approvals
United Therapeutics announced that the US Food and Drug Administration (FDA) has granted Premarket Approval (PMA) for its LungFX perfusion device. The system, which...

NeuroBell secures €5m in new funding for US launch

Funding
Cork-based medical technology company NeuroBell has successfully secured $5.5 million (€4.8 million) in a new investment round to accelerate the United States launch of...

Wearable neurotech company NeuroLife launches with $2.9M to restore movement after stroke

Funding
NeuroLife, the market-facing brand of ActivateNeuro, Inc., has launched out of a strategic partnership between Battelle and The NeuroTech Institute to develop non-invasive neurotechnology...

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Coherence Neuro begins first clinical study for BCI

Coherence Neuro has initiated its first clinical study of the investigational Cipher brain-computer interface (BCI), marking its transition into human testing. The study, led by...

Imperative Care reports SYMPHONY-PE trial data for pulmonary embolism

Imperative Care has reported results from a post-hoc analysis of the SYMPHONY-PE trial, evaluating the impact of early mechanical thrombectomy in patients with intermediate-risk...

VahatiCor enrolls first U.S. patient in SERRA-I clinical study of A-FLUX Reducer System

VahatiCor has enrolled the first U.S. patient in its SERRA-I early feasibility study, evaluating the investigational A-FLUX Reducer System® for patients with coronary microvascular...

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...

Innovation

Regulatory Approvals

Bioness wins FDA clearance for portable neurostimulator for stroke recovery

Bioness Medical has received FDA 510(k) clearance for its PoNS (Portable Neuromodulation Stimulator) system to treat dynamic gait deficit caused by chronic stroke symptoms....

United Therapeutics gets FDA green light for lung perfusion device

United Therapeutics announced that the US Food and Drug Administration (FDA) has granted Premarket Approval (PMA) for its LungFX perfusion device. The system, which...

NeuroBell secures €5m in new funding for US launch

Cork-based medical technology company NeuroBell has successfully secured $5.5 million (€4.8 million) in a new investment round to accelerate the United States launch of...

Wearable neurotech company NeuroLife launches with $2.9M to restore movement after stroke

NeuroLife, the market-facing brand of ActivateNeuro, Inc., has launched out of a strategic partnership between Battelle and The NeuroTech Institute to develop non-invasive neurotechnology...

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