A wearable biosensor developed by Scottish startup Pneumowave Ltd. has been tapped for a clinical trial investigating respiratory depression at King’s College London (KCL). Pneumowave’s respiratory monitoring platform will be used to collect breathing data from patients at risk of experiencing slow and shallow breathing as a side effect of opioid medication.

Innovheart srl has landed more than $55 million to continue clinical trials of its transcatheter mitral valve replacement (TMVR) system for the treatment of mitral valve disease. The series C equity round was led by Grand Pharmaceutical Group Ltd. (Grand Pharma), together with existing investors Genextra, Panakes Partners and Indaco Venture Partners.

PARIS – Mikajaki SA reported the commercial launch of Eyelib, a robotic ophthalmic diagnostics platform. One year after obtaining CE marking, the Swiss-based med-tech is rolling out a wide-scale launch of its automatic ophthalmology examination system onto the European market.

LONDON – The EU’s third generation public-private research partnership in health formally got off the ground on Jan. 26, with a promise to invest €2.4 billion (US$2.7 billion) and back 30 large-scale, cross-sector innovation projects by 2030. The Innovative Health Initiative is the successor to the Innovative Medicines Initiatives 1 and 2, which between 2008 – 2020 put €5 billion into precompetitive research to accelerate translation of biomedical research to new drugs.

Smith & Nephew plc added new indications for use of its Pico 7 and Pico 14 single-use negative pressure wound therapy (sNPWT) systems. The FDA cleared the London-based device maker’s systems for reducing the incidence of both deep and superficial incisional surgical sites and dehiscence. Smith & Nephew’s Pico 7Y system, which treats two wounds simultaneously, was also cleared to aid in the reduction of the incidence of superficial incisional SSIs for high-risk patients in class I wounds, post-operative seroma and dehiscence.

The European Council adopted a regulation Jan. 25 giving the EMA a stronger role in crisis preparedness and the management of drugs and medical devices during a crisis.

Supply chain issues overshadowed Royal Phillips NV fourth-quarter 2021 results, as the Dutch conglomerate reported sales of $5.5 billion (€4.9 billion), a 10% organic year-on-year decline. Philips management said sales were impacted by several headwinds, including supply chain challenges and postponement of equipment installations in hospitals related to COVID-19. The recall of the Respironics device also caused a double-digit decline in the sleep & respiratory business.

LONDON – The industry is expressing divergent views of changes to how the U.K. health technology assessment agency, the National Institute for Health and Care Excellence (NICE), will in the future select what products to assess and the methods and processes it will use to carry out its evaluations.

Exoskeleton company Wandercraft SAS has landed $45 million in a series C round led by U.S. fund Quadrant Management. The company’s first commercial exoskeleton, Atalante, received CE marking in 2019 and has sold for around $176,000 a piece to European rehabilitation hospitals offering gait re-learning treatment.

PARIS – Robocath SAS has concluded an initial clinical study in Europe to demonstrate the safety and efficacy of robotic coronary angioplasty performed using its R-One platform. Sixty-two patients from six European hospitals participated in the R-Evolution clinical study. The study was aimed at assessing the safety and efficacy of the R-One robotic assistance platform.