In response to the COVID-19 pandemic, health systems around the world are looking to digital technologies to support health delivery but where exactly can these technologies have the most impact? At the Medtech Forum in Barcelona, European leaders gathered to discuss practical examples of how digital tools can help make health systems more efficient.
When it comes to innovation, Europe has a thing or two it can learn from the U.S. according to European leaders. Speaking at the Medtech Forum meeting in Barcelona, Medtech Europe CEO Serge Bernasconi said Europe’s focus on safety issues is stifling innovation across the continent.
As the implementation date of In Vitro Diagnostic Regulation (IVDR) looms on May 26, 2022, significant uncertainty remains around the new regulatory system. Under Directive 98/79/EC around 10% of all IVDs placed on the market need notified body involvement, whereas under the IVDR this will rise to 80%-90%. Notified body shortages continue to be a major challenge for industry, with many manufacturers yet to receive certification. The situation is expected to be particularly problematic for SME manufacturers who will see most of their products blocked on the market if they don’t receive validation in time.
Mirvie Inc. has secured U.S. FDA breakthrough device designation for its pre-eclampsia risk test. The blood test combines machine learning and liquid biopsy technology to provide an RNA profile that predicts pregnancy risks before symptoms occur. It is the first test to be recognized by the FDA for the early identification of pre-eclampsia.
Xeltis BV plans to expedite an international pivotal trial investigating its restorative hemodialysis access graft Axess following encouraging preliminary data. The company released results from a clinical trial investigating the graft at CX 2022, the Charing Cross International Symposium on Vascular and Endovascular Challenges, in London. Data showed the graft had 100% functional patency and safety in a patient cohort of 11, with a median follow-up of 6.5 months.
The U.S. FDA has granted premarket approval for Transmedics Group Inc.’s OCS heart system for use with organs from donors after circulatory death (DCD). The approval expands on a prior FDA approval of the device for use with organs from donors after brain death in September 2021. Andover, Mass.-based Transmedics said its system can now be used for ex vivo reanimation, functional monitoring, and beating-heart preservation of donation-after-circulatory-death hearts.
Acutus Medical Inc. is selling its left-heart access portfolio to Medtronic plc in a deal worth upwards of $50 million. The portfolio of devices includes a line of sheath-compatible septal crossing devices and steerable sheaths. Under the terms of the agreement, Medtronic will make an upfront cash payment to Acutus of $50 million and additional undisclosed payments based on milestones and future sales.
Be’er Sheva, Israel-based Dia Imaging Analysis Ltd. has partnered with technology conglomerate Intel Corp. to accelerate the analyzing time of its artificial intelligence (AI)-based cardiac ultrasound software. Dia said Intel’s Open Vino toolkit will optimize the processing time of its Lvivo Seamless solution by over 40%.
The rehabilitation robot market will soon have a new entrant as Able Human Motion SL prepares to launch a next-generation robotic exoskeleton. The Universitat Politècnica de Catalunya spin-off is on a mission to shake up the exoskeleton technology market with a low-cost, lightweight model that can be accessed by anyone with mobility impairments.
A technology developed at the University of Birmingham, U.K., has been spun off as a potential treatment for ocular surface diseases. The platform technology from startup Healome Therapeutics Ltd. was developed by a team of material scientists at the University’s Healthcare Technologies Institute (HTI) that translates health technology concepts to products for clinical trials.
