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 – After a number of equivocal small studies, the U.K. Recovery trial has applied its heft to turn in statistically significant evidence that the rheumatoid arthritis treatment Roactemra (tocilizumab) reduces mortality in hospitalized COVID-19 patients.
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.
In its first decision on excessive drug pricing, the European Commission (EC) accepted a commitment Feb. 10 from Aspen Pharmacare Holdings Ltd. to immediately drop the price of six essential cancer drugs in Europe by an average of 73% and to continue to supply the drugs for at least the next five years.
Under threat of emerging variants, the EU is taking to heart lessons learned so far in the global COVID-19 pandemic to accelerate the review of vaccines, improve data sharing from clinical trials and address the difficulties inherent in the mass production of vaccines that may contain up to 400 components.
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.
LONDON – A follow-up study of participants in the phase II/III U.K. trial of Astrazeneca plc’s COVID-19 vaccine has shown it remains effective against the new B.1.1.7 variant of SARS-CoV-2.
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