PARIS – Researchers at the Biomechanics and Bioengineering laboratory (BMBI), a joint venture between the Compiègne University of Technology in Oise, France, and the National Center for Scientific Research (CNRS), have designed a new implant intended for minimally invasive surgery for mitral valve repair. One of the BMBI teams has been working closely two cardiovascular surgeons from the University Hospital of Henri-Mondor to develop this new minimally invasive approach in the treatment of mitral valve regurgitation.
Livanova plc has inked an agreement with Gyrus Capital SA to divest its heart valve business. The sale has an enterprise value of €60 million (US$73 million) and is expected to wrap up in the first half of next year. The Livanova board has already given its unanimous assent for the deal. Livanova now expects to strengthen its focus on its neuromodulation and cardiovascular platforms.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: New notified body for IVDs brings total to five; U.S. securities compliance not optional for foreign companies; USPTO touts early results of amendment pilot.
PARIS – Corwave SA has obtained $600,000 as part of the Ile-de-France region's stimulus plan, to boost development of its Neptune cardiac support pump. This subsidy is part of the manufacturing recovery plan for the Ile-de-France region, aimed at very small enterprises (VSEs), small and medium-sized enterprises (SMEs) and mid-cap companies. In the midst of the COVID-19 pandemic, the Ile-de-France Region is supporting re-industrialization in a region that brings together 12.1 million inhabitants, or nearly 19% of the French population.
Salient Bio launched a robotics-driven PCR test for COVID-19 with 99% for use in mass testing for the virus. The company says the "fastest ever" test notifies users of test results in less than a day and is priced to be cost effective for businesses. Salient plans to expand the number of tests utilizing the modular diagnostics platform in 2021 to include a range of pathogens. Even with vaccines on the horizon in the coming months, the London-based company expects brisk demand for its product.
LONDON – Long-awaited guidance on the EU regulation for in vitro diagnostics (IVD) that comes into force in May 2022 arrived as the industry increased its calls for implementation to be postponed, citing the extent to which the COVID-19 pandemic has derailed work on bringing products into compliance with the new rules.
Medtronic plc reported second quarter worldwide revenue of $7.647 billion, a decrease of 0.8% as reported and 1.5% on an organic basis. Analysts noted, however, that the figure beat the consensus of $7.08 billion. It also exceeded Wells Fargo’s $7.12 billion estimate. With the continued uncertainty related to the ongoing COVID-19 pandemic, the Dublin-based company did not provide formal annual or quarterly financial guidance. Still, the need for ventilators pushed the company ahead.
PARIS – Carmat SA has closed an $11.8 million loan in the form of a government-backed loan from a French banking syndicate. In an environment made uncertain by the COVID-19 crisis, Carmat will be able to continue its clinical development program on its total artificial heart, undisturbed. “This financing facility contributes to securing our cash position and extends our financial visibility through to the third quarter of 2021,” Stéphane Piat, CEO of Carmat, told BioWorld.
PARIS – Ganymed Robotics SAS reported the successful completion of functional prototype testing for its surgical robotic assistant used in total knee arthroplasty. According to a systematic review of the literature, published in the Journal of Arthroplasty, more than 2 million patients undergo knee arthroplasty each year after suffering arthritis of the knee.
The European Commission has awarded the CE mark to Hologic Inc. for its Genius Digital Diagnostics system for cervical cancer screening. According to the company, it is the first digital cytology platform to combine a new artificial intelligence (AI) algorithm with advanced digital imaging to assist cytotechnologists and pathologists in detecting precancerous lesions and malignant cells in women.