Essilorluxottica SA received U.S. FDA clearance for its over-the-counter Nuance Audio Glasses, which combines sight and sound technologies, to help people improve their vision and hearing. The device also received a CE mark certification under the Medical Devices Regulation from the EU authorities.

The EU’s Medical Device Coordination Group issued a guidance on the types of products that qualify as in vitro diagnostics (IVDs), including some important distinctions even in instances in which a given analyte is the subject of two tests.

Tensive S.r.l. raised €14 million (US$14.5 million) in a series A financing round for its bio-absorbable breast implant Regenera, for patients undergoing reconstructive surgery after lumpectomy. The funds will be used to complete a pivotal clinical trial to evaluate the safety and performance of the technology.

A new guidance by the International Medical Device Regulators Forum for good machine learning practices draws heavily on a 2021 playbook provided by Canada, the U.K. and the U.S., an outcome that also supports the notion that there is no point in reinventing a highly functional regulatory wheel.

Continuing a cascade of positive news for Stereotaxis Inc., the company reported the first order for its petite Genesisx robot in Europe. The system received CE mark in August, but management held off its launch until its Magic radiofrequency ablation catheter also received CE mark, which happened on Jan. 27. The two devices are used together to treat cardiac arrhythmias.

Neu Health Ltd. received $2 million in funding from Cedars-Sinai Intellectual Property Company and Oxford Science Enterprises (OSE) to bring its platform, designed for Parkinson’s disease and dementia care, into the U.S.

The EU has moved aggressively on legislation in recent years, with the AI Liability Directive serving as the latest example of legislation that sparked widespread opposition.

Nobi BV secured €35 million (US$37 million) in an oversubscribed series B financing round to develop its artificial intelligence (AI)-powered smartlights which can detect falls in the elderly.

A new bioprinting platform to create tissues that can change shape as a result of forces generated by the cells, similar to what happens naturally during organ development, was developed by researchers from the University of Galway, Ireland.

The U.K.’s new postmarket monitoring requirements do not represent a sea change in device makers’ responsibilities in this area, but the expansions of responsibility are nonetheless significant.