If the SARS-CoV-2 virus has achieved anything useful in the world of in vitro diagnostics, it’s that the associated pandemic has shone a bright and unsparing light on the respective merits of diagnostic and surveillance testing. Harvard University’s Michael Mina, an assistant professor of epidemiology, was one of several academic researchers who took up the gauntlet yet again in opposition to what they characterized as a gross misunderstanding of the respective roles of these types of tests, a misunderstanding they said must be addressed if the pandemic is to be corralled.
Cardiacsense Ltd.’s medical watch received CE mark for the detection of atrial fibrillation and heart rate variability monitoring. The watch provides continuous, long-term monitoring of heart arrhythmias without cumbersome external devices or invasive implants. The European clearance does not require a prescription for use and will enable the Caesarea, Israel-based company to begin distribution under a number of agreements the company signed in 2020.
Blue Ocean Spine GmbH has won a major investment from SHS GmbH, also from Tuttlingen in Germany, to develop its next-generation functional spinal implant. The two companies are declining to disclose the size of the series A investment.
LONDON – The EMA has requested all COVID-19 vaccine developers to investigate if their products offer protection against new variants of SARS-CoV-2 and to submit the relevant data.
PARIS – Ecential Robotics SAS has just secured $120 million series C funding in equity and debt financing, to support the manufacturing and commercial development of its robotic platform for spinal surgery. This is the largest financial transaction undertaken by any med-tech company in France.
LONDON – It began life as a legal tidy-up of post-Brexit regulatory issues, but the Medicines and Medical Devices bill that emerged from its final reading last week is in a significantly different form. Most notably, the bill legislates for the creation of a national register of all implantable medical devices and the appointment of a patient safety commissioner to act a single port of call and advocate for patients when devices fail.
PARIS – Four years after being set up in Marseilles, France, Volta Medical SAS reported raising $28 million in a series A round for the VX1 software mapping system, an artificial intelligence (AI) algorithm that is compatible with most readily available multipolar catheters and technology used in operating rooms and cath labs to treat cardiac arrhythmia.
In a task made more challenging by COVID-19, the EU and the World Health Organization are rolling out separate plans to take down cancer in Europe. The European Commission Feb. 3 announced its Europe’s Beating Cancer Plan, the first comprehensive European cancer initiative in nearly 30 years. A day later, WHO/Europe launched its United Action Against Cancer, billing it as a “pan-European cancer movement” to galvanize support and cooperation from grassroots to governments with the long-term goal of eliminating cancer as a life-threatening disease in the region.
BERLIN – The German government has just made $3.6 billion available to the Future of Hospitals Act (Krankenhauszukunftsgesetz, KHZG), through the liquidity reserve of the health fund in order to support public hospitals with digital transformation. Besides this government cash injection, an additional $1.6 billion will be made available through co-funding by the German federal states, the 16 Länder. In total, German hospitals will get a $5.2 billion funding to boost digitization.
LONDON – The U.K. National Institute for Health and Care Excellence (NICE) has published new advice on how and when artificial intelligence (AI) could be applied to the interpretation of mammograms and chest computer tomography images, in a move that is intended to set the ground rules for the uptake of these technologies. In population breast screening, NICE looked at how five AI systems could be used to pick out mammography images that need further assessment, supporting qualified radiologists in their interpretation.