Pulse Biosciences Inc. received U.S. FDA breakthrough device designation for its Cellfx cardiac surgery system with surgical clamp for ablation of atrial fibrillation. The Cellfx system uses nanosecond pulsed field ablation technology to deliver durable, continuous transmural ablation.
Embattled Masimo Corp. disclosed it received a non-binding term sheet offering $850 million to $950 million for a potential joint venture that would include its consumer health products and the Sound United business. In an 8-K filing with the U.S. Securities and Exchange Commission, Masimo said it intends to negotiate for a higher price.
The years’ long effort by activist investor Politan Capital Management LP to take control of the Masimo Corp. board of directors and oust Masimo CEO and founder Joe Kiani took a turn for the weird this week as news emerged that Masimo Chief Operating Officer Bilal Muhsin notified the board that he would step down if Kiani were pushed out.
Quest Diagnostics Inc. agreed to purchase Canadian laboratory testing giant Lifelabs Inc. from the Ontario Municipal Employees Retirement System for US$985 million (CA$1.35 billion), including debt, in a deal expected to close by the end of the year. Quest projects that Lifelabs, which will retain its brand, headquarters and management, will contribute US$710 million in the first 12 months after closing.
Merit Medical Systems Inc. acquired the Esophyx Z+ device from Endogastric Solutions Inc. for $105 million in cash, adding a durable, non-pharmacological treatment for gastroesophageal reflux disease to its line-up of gastrointestinal products.
Clarius Mobile Health Corp. received U.S. FDA clearance for the Clarius OB artificial intelligence biometric measurement tool, which is designed to improve access to accurate prenatal monitoring in low-resource regions. The system automatically estimates fetal age, weight and growth intervals critical to assessing fetal health and early identification of potential issues and multiple pregnancies.
Agilemd Inc. received U.S. FDA clearance for its Ecart clinical deterioration suite, an artificial intelligence-powered software as a medical device that uses a machine learning algorithm to continuously evaluate the risk of a hospitalized patient’s death or transfer to intensive care based on 97 real-time variables.
Continuous glucose monitors continue to post positive results for managing diabetes in an ever-expanding population. Long a mainstay of disease management for those with type 1 diabetes, the devices have also proved themselves in treating type 2 diabetes that requires multiple daily injections of insulin.
All eyes were on Tandem Diabetes Care Inc.’s presentation of the tiny Mobi pump at a standing-room-only event during the American Diabetes Association’s 84th Scientific Sessions in Orlando. In addition to showcasing the 18 ways the device can be worn, Tandem highlighted results from its user survey which found that 86% of respondents reported that the device improved their quality of life.
Endogenex Inc. closed an oversubscribed $88 million series C financing round to support completion of its investigational device exemption trial for the Recet system. The Recet system uses non-thermal pulsed electric fields to remodel the duodenal tissue to treat adults with type 2 diabetes.
