A U.S. FDA advisory committee voted 14 nays to three ayes that the benefits of the Lutonix 014 drug-coated balloon (DCB) do not outweigh the risks in a panel proceeding peppered by problems with missing data and a lack of operator blinding. The panel widely saw the use of paclitaxel-eluting technologies in other areas of the vasculature as a reassurance that this device might perform as promised, but the outcome nonetheless leaves the sponsor with a new round of negotiations with the FDA as to how to move forward.

TORONTO – Think of it. More than 14,000 facilities boasting 98% of the largest hospital chains across the U.S., two-thirds of skilled nursing facilities and hospice organizations and doctors’ offices. It’s that broad customer base Kent Imaging Inc. will have access to following its Jan. 26 agreement with medical software and analytics giant Net Health Inc., helping to expand the footprint of Kent Imaging’s Snapshot device for assessing non-healing wounds, notably those arising from diabetes.

Humacyte Inc., which develops universally implantable, bioengineered human tissue at commercial scale, has agreed to go public via a merger with Alpha Healthcare Acquisition Corp. (AHAC), a blank-check company led by Rajiv Shukla. Upon closing of the deal, AHAC will be renamed Humacyte Inc. and will be led by Humacyte’s current CEO, Laura Niklason. The combined company’s stock is expected to list on the Nasdaq Capital Market under the ticker symbol HUMA.

Researchers at Thomas Jefferson University have implanted brain electrodes in a patient who suffered a subcortical ischemic stroke more than a year ago to help them overcome abnormal muscle tone and control a robotic arm brace. Artificial intelligence (AI) algorithms interpret neuronal signals recorded by the electrodes into movement of the brace.

HONG KONG – Rsip Vision Ltd. have developed a new coronary artery segmentation tool based on deep learning technology that should allow for faster 3D models of coronary artery anatomy and facilitate precise measurements of artery length and diameter.