Orchestra Biomed Inc. struck a deal with Medtronic plc to develop a cardiac neuromodulation therapy as a potential integrated hypertension treatment for cardiac pacemaker patients. Medtronic also joined a $110 million series D round, led by RTW Investments, to invest in the biomedical company as it announced plans to list on the Nasdaq.
Enovis Corp. reported that it has completed its acquisition of Insight Medical Systems Inc., the developer of a wearable surgical navigation system to enhance surgeon performance during orthopedic procedures. Financial terms of the deal were not disclosed.
The U.S. FDA has applied a class I designation to the recall of Flow-c and Flow-e anesthesia systems manufactured by Getinge AB of Gothenburg, Sweden, due to reports of faulty on-off switches, which could lead to a failure to provide the needed suction. While no injuries or fatalities have been reported in connection with the problem, the FDA said one possible consequence of device failure is pulmonary obstruction that could ultimately lead to death.
The U.S. Securities and Exchange Commission (SEC) filed insider trading charges against Doron Tavlin, formerly the vice president of business development for Mazor Robotics Ltd., of Caesarea, Israel, over a transaction that took place four years ago. The SEC is charging Tavlin with disclosing the then-impending acquisition of Mazor by Dublin-based Medtronic plc. to a personal friend, but these types of activities are becoming easier to detect thanks to analytics used by the SEC.
SD Biosensor Inc. and SJL Partners LLC plan to take Meridian Biosciences Inc. private in a $1.53 billion cash deal reached after four months of negotiation. Meridian shareholders will receive $34 per share, which represents a premium of 32% on the share price at market close on March 17, the day before SDB and SJL first presented an offer to buy the company. On July 7, the proposed price was a 16% premium based on the one-month average price per share of Meridian’s common stock.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Arcoma, Renovia, Zsquare.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Ancora Medical, Bio-Gate, Biora, Biotronik, Caris, Milestone Scientific, Nico, Scilex, Scworx, Sorrento.
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