Recent Developments:
New Product Launches & Approval:
In March 2023, LivaNova PLC, a medical technology and innovation company, announced that it has received the U.S. Food and Drug Administration (FDA) 510(k) clearance for its Essenz Heart-Lung Machine (HLM). LivaNova PLC initiated the commercial launch of Essenz in the U.S.
In January 2022, XVIVO, a medical technology company, received ‘510(k) clearance’ from the U.S. FDA for its portable organ perfusion system, a Kidney Assist Transport. It facilitates donor kidneys’ continuous hypothermic pulsatile perfusion using an oxygenated preservation solution throughout the transportation process from the donor to the recipient in transplant procedures.
In November 2021, Dongguan Kewei Medical Instrument Co., Ltd., a subsidiary of MicroPort Scientific Corporation, a medical device company, received approval of National Medical Products Administration (NMPA) of China for the Vitasprings Spiral Diversion Integrated Membrane Oxygenator. Vitasprings is a product developed in China that imitates the function of the lungs in cardiopulmonary bypass and adopts an innovative hemodynamic structure featuring a spiral flow guide and secondary diversion combined with a vortex exhaust design, which can reduce damage to blood cells.
Acquisition, Collaboration, and Partnerships:
In September 2022, CHS USA Inc., a privately-held medical device manufacturer, announced the acquisition of SandBox Medical LLC, the manufacturer and source for JollyPop Pacifiers and other products designed for premature babies and full-term newborns. This acquisition will increase CHS USA Inc.'s presence in the Neonatal Intensive Care Unit (NICU) and pediatric market, while providing innovative products for premature babies and full-term newborns.
In September 2020, XVIVO, a medical technology company, announced acquisition of Organ Assist B.V., a company that focuses primarily on developing machines and consumables for liver and kidney perfusion. Through the acquisition, XVIVO became the first organ preservation and evaluation company to be actively involved in all major organs, which accelerates the company’s strategy of becoming a global all organ provider.
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