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.

PARIS – Esight Corp. is starting distribution of its newest low-vision assistive technology in France, Germany and the U.K. The latest version of the technology, the Esight 4, was designed to be more versatile and mobile than before, has double the display brightness and has improved the auto-focus function, according to the company.

Novocure Ltd. has scored another win, this time gaining the CE mark for the NovoTTF-100L system. As a result, Novocure plans to commercialize the device as a first-line treatment in combination with pemetrexed and platinum-based chemotherapy for unresectable, locally advanced or metastatic, malignant pleural mesothelioma (MPM).

LONDON – Clinical genomics specialist Congenica Ltd. has raised $50 million in a series C round that will enable it to extend beyond its roots in rare disease diagnosis to personalized medicine in cancer, and health and wellness, while expanding its geographical reach.

PARIS – Med-El Elektromedizinische Geräte GmbH has reported the first successful procedure in Europe for a totally implantable cochlear implant (TICI). The surgery was performed at Liège University Hospital in Belgium. “This TICI is a major step in cochlear implant technology. It has been the aim since the beginning of cochlear implants to be able to integrate all the components into a single internal device,” Philippe Lefebvre, head of the otorhinolaryngology department at Liège University Hospital, told BioWorld.

PARIS – Oncomfort SA has entered a partnership with Vygon SA for distribution of its Sedakit in six countries in Europe. The synergy between Vygon’s specialization and Oncomfort’s fields of application aims to enable greater acceleration of the adoption of Digital Sedation by health care professionals and patients. “Thanks to this strategic partnership, our new technology for relieving patient pain and anxiety without medication is going to be widely available in Europe,” Mario Huyghe, CEO of Oncomfort, told BioWorld.

LONDON – The U.K.’s influential health technology assessment body, the National Institute of Health and Care Excellence (NICE), is consulting stakeholders on proposed changes to how it selects medical devices, diagnostics and drugs for evaluation.

Royal Philips NV is reporting the launch of Philips Ventilator Bipap A40 EFL, a noninvasive ventilator that aims to help patients with chronic obstructive pulmonary disease (COPD) breathe easier. With its CE mark in hand, the company has tagged initial target markets as France, Italy and the U.K. Additional European markets are expected to come next year.

PARIS – Fineheart SA has announced the success of a 30-day preclinical trial to evaluate its implantable cardiac output management system (ICOMS) for patients suffering from severe heart failure. The device was well-tolerated with no related adverse events seen during the 30 days.