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.”
Class III medical devices represent the highest risk class of medical devices according to the MDR. Therefore, these devices are required to meet extensive clinical safety and performance requirements and undergo the highest level of device approval. Obtaining the first MDR certificate for a Class III medical device is just the first in a series of vital steps towards MDR certification of BIOTRONIK’s entire product portfolio. Mr. Borkowski commented: “With our first MDR milestone, we are pleased to have set a precedent for the future.”
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.
17 million Euros: inveox acquires further investment
Munich startup inveox continues to grow. With its largest investment so far of 17 million euros, the company will begin the series-level production of their AI-supported automation system in order to make cancer diagnoses faster and more reliable. To Managing Partner Dominik Sievert, the most recent investment means more than financial support: “the investors believe in us because inveox has displayed unprecedented strong growth in just a short time. They believe in our product, our leadership and our vision, and more importantly they provide us with an invaluable asset beyond the investment: mentoring.” Currently, the IoT/SaaS integral system – consisting of a lab automation machine, an intelligent sample container, and AI-enhanced software – is being implemented with several customers in the D/A/CH region including well-known university clinics in Germany. The entry into further markets within and outside of Europe is planned for the later this year. Details on the inveox website.