Epineuron receives FDA 510(k) clearance for Evala Nerve Stimulator

Regulatory Approvals
Epineuron, a medical device company pioneering bioelectronic medicine, announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the Evala® Nerve Stimulator. This handheld, intraoperative electrical stimulation device is engineered...

Epineuron receives FDA 510(k) clearance for Evala Nerve Stimulator

Regulatory Approvals
Epineuron, a medical device company pioneering bioelectronic medicine, announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the Evala®...

Rivermark secures $20M in Series D for late-stage prostate device trial

Funding
Wisconsin-based medtech Rivermark Medical has secured $20m in a Series D financing round – supporting the company’s late-stage clinical activities being used for approval...

SonoMind raises $23.5M for focused ultrasound-based depression therapy

Funding
Sonomind announced that it raised $23.5 million (€20 million) in its Series A funding round led by Critical Path Ventures and Bpifrance. The French startup...

Aurie wins FDA nod for reusable intermittent catheter system

Regulatory Approvals
Aurie announced that it received FDA de novo clearance for its Aurie Reusable No-Touch Intermittent Catheter System. The Syracuse, New York-based company says the milestone...

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Finance

Funding

Clinical Trials

Reprieve Cardiovascular pilot study backs heart failure system

Reprieve Cardiovascular announced the publication of results from a pilot study of its heart failure therapy. Milford, Massachusetts-based Reprieve Cardiovascular develops the Reprieve Therapy. It...

MMI completes first robotic-assisted procedure in Alzheimer’s patient

Medical Microinstruments (MMI) announced the completion of the first robotic-assisted procedure in its REMIND U.S. IDE study. REMIND evaluates microsurgical intervention for neurodegenerative disease. MMI...

CVRx enrolls first patient in study of Barostim therapy for heart failure

CVRx announced that it enrolled the first patient in its landmark BENEFIT-HF study of its Barostim therapy. Barostim delivers electrical pulses to baroreceptors in the...

Sensome reports positive findings for clot-sensing guidewire

Sensome announced the publication of first-in-human results from the CLOT OUT study evaluating its Clotild smart guidewire system. Findings published in the Journal of Neurointerventional...

Innovation

Regulatory Approvals

Epineuron receives FDA 510(k) clearance for Evala Nerve Stimulator

Epineuron, a medical device company pioneering bioelectronic medicine, announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the Evala®...

Rivermark secures $20M in Series D for late-stage prostate device trial

Wisconsin-based medtech Rivermark Medical has secured $20m in a Series D financing round – supporting the company’s late-stage clinical activities being used for approval...

SonoMind raises $23.5M for focused ultrasound-based depression therapy

Sonomind announced that it raised $23.5 million (€20 million) in its Series A funding round led by Critical Path Ventures and Bpifrance. The French startup...

Aurie wins FDA nod for reusable intermittent catheter system

Aurie announced that it received FDA de novo clearance for its Aurie Reusable No-Touch Intermittent Catheter System. The Syracuse, New York-based company says the milestone...

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