Briefs

ConMed to Acquire SurgiQuest for $265M

Surgical device provider ConMed will acquire SurgiQuest for $265 million. SurgiQuest markets the AirSeal system, an integrated access management technology for use in laparoscopic and robotic procedures that consists of a valve-free trocar. It also provides continuous pressure sensing and an integrated insufflator and smoke evacuator. According to ConMed, clinical data show that AirSeal leads to shorter procedure times and reduced postoperative pain. The transaction is expected to close in the first quarter of 2016.

Alphaeon to Acquire Lensar for $59M

Alphaeon will acquire medical device company Lensar in a transaction valued up to $59 million. Lensar is a manufacturer of the Femtosecond lasers systems for cataract treatment. Its Lensar system is designed for patients seeking an enhanced vision outcome following the removal of their crystalline lens. The transaction is subject to the completion of certain closing conditions on or before December 31.

FDA Clears INOmax DSIR Plus MRI Device

Specialty biopharmaceutical company Mallinckrodt has received FDA clearance for its INOmax DSIR Plus MRI device for the delivery of nitric oxide for inhalation during MRI procedures. The system provides a constant concentration of nitric oxide to the patient and is indicated for use only with magnetic resonance-conditional ventilators validated to be compatible. Clearance is based on the determination of substantial equivalence to the INOmax DSIR. The new device includes hardware modifications to the cart, as well as a software update with an MRI set-up wizard and modified labeling. The company plans to commercialize the device this month.

CDRH Holds Experientiall Learning Training

Medical device industry, academia and healthcare facilities are invited to participate in the 2015 Experiential Learning Program General Training Program, which is intended to provide CDRH staff with an opportunity to understand the policies, laboratory practices and challenges faced in broader disciplines that affect the device development life cycle. Requests to participate must be submitted either electronically or in writing by Dec. 16. Read the notice here: www.fdanews.com/11-15-FDA-ELP.pdf.

ElMindA Raises $28M for BNA System

Neuroscience-based technology company ElMindA has raised $28 million in Series C financing to continue advancing its proprietary Brain Network Activation system, which uses multi-channel EEG-ERP electrophysiology technology to provide a more accurate, objective assessment of brain functionality over time. ElMindA also will use the funds for commercial and clinical adoption following BNA’s 2014 FDA clearance in the U.S., and CE Mark approval in Europe for brain function assessment. The investors include Shanda Group, New England Patriots owner – The Kraft Group, Wexford Capital, WR Hambrecht & Co, Palisade Capital Management, OurCrowd and Healthcrest AG.