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. Read More
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. Read More
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. Read More
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. Read More
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. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Anaconda Biomed, Catalyst Orthoscience, Genmark Diagnostics, Vocalis Health. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Delta International Services & Logistics, Everlywell, Horiba Medical, Thermo Fisher Scientific, Vax-Immune Diagnostics. Read More
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: HHS commits more funds for testing, materials to fight pandemic; Medtronic announces recall of Valiant Navion; Florida man pleads guilty in DME fraud. Read More
Keeping you up to date on recent developments in orthopedics, including: Radioactive bone cement may be safer in treating spinal tumors; Unlocking the mystery behind skeletal aging; Sweet coating for sour bones. Read More
