Helius Seeks FDA De Novo For Portable Neuromodulation Stimulator For MS Patients
The FDA has asked the company for more information to support its PoNS therapy for multiple sclerosis patients with gait deficit, including an additional analysis of clinical data and labeling modifications.
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Helius Medical announced on April 10 that the US FDA has declined its de novo application for treating brain injury with its Portable Neuromodulation Stimulator.
Reuters reported that global private equity firm Carlyle Group has offered to pay at least $7bn for Medtronic’s patient monitoring and respiratory interventions businesses. Medtronic announced its plan to get out of those businesses about one year ago.
‘Build A Company To Be Bought, Not Sold,' 'Match The Asset To The Capital,' And Other Advice From VC Experts
At the recent LSX World Congress USA in Boston, Medtech Insight’s Reed Miller moderated a panel of experienced medtech investors to discuss the current medtech venture financing environment and offer advice for entrepreneurs raising money to support their innovations.