Olympus takes over Versapoint Electrosurgery tech
Olympus Corporation announced today that it entered an agreement with Ethicon, Inc., in which Olympus will take over all new commercial activities related to the Versapoint™ Electrosurgery system from Ethicon. With this agreement, Olympus will acquire new channels in its Gynecology Business toward its goal of bringing patients and customers more minimally invasive technology and product options. The system is used for the treatment of various intrauterine pathologies such as myomas, polyps, intrauterine adhesions and uterine septa. Details on the agreement on the Olympus Europe website.
Biotronik obtains the MDR Certification for a Class III medical device
Biotronik announced that it is the world’s first manufacturer to receive European Medical Device Regulation (MDR) certification for a Class III (highest risk) medical device. “The MDR brings a complete change to the regulatory framework for medical devices in Europe that emphasizes quality and safety,” said Roman Borkowski, Senior Vice President Quality Management and Regulatory Affairs, Cardiac Rhythm Management at Biotronik. “As a global leader in cardio- and endovascular medical technology, Biotronik has a long history of commitment to quality and safety. That’s why we are very proud to be the first company to demonstrate conformity to the highest MDR risk classification.”
FDA approval for Barostim Neo
The U.S. Food and Drug Administration (FDA) approved the Barostim Neo System for the improvement of symptoms in patients with advanced heart failure who are not suited for treatment with other heart failure devices, such as cardiac resynchronization therapy. The FDA gave the device a Breakthrough Device designation because it treats a life-threatening disease, heart failure, and addresses an unmet medical need in patients who fail to get adequate benefits from standard treatments and have no alternative treatment options. “This approval provides patients with a new treatment option for the symptoms associated with advanced heart failure,” said Bram Zuckerman, M.D., director of the Office of Cardiovascular Devices in the FDA’s Center for Devices and Radiological Health. More information on the approval on the FDA website.
Siemens Healthineers to acquire Corindus
Siemens Healthineers AG has entered into a merger agreement with U.S.-based Corindus Vascular Robotics, Inc., a global technology leader for robotic-assisted vascular interventions. "With this acquisition, we are opening up a new field for our image-guided therapies business. Together with our strong portfolio in imaging, digitalization and artificial intelligence, we are creating significant synergies to advance therapy outcomes", said Bernd Montag, CEO of Siemens Healthineers AG. Details on the agreement can be found on the Siemens Healthineers website.