Interim results from the PRIMAVERA study published in the New England Journal of Medicine demonstrated that Science Corp.'s Prima retinal implant restored vision, enabling 80% of patients to read at 12 months. Participants had age-related macular degeneration-related geographic atrophy resulting in total loss of central vision.
The European Commission has proposed legislation that would ease some of the EU’s barriers to innovation, but MedTech Europe said that while the European Innovation Act would be helpful, it is no substitute for fixing what’s already ailing the EU med-tech industry.
Vertebral compression fractures are one of the more obvious signs of osteoporosis but can be difficult to diagnose, one of several reasons the U.K. National Institute for Health and Care Excellence has given the nod to five AI products that can improve rapid detection of these fractures.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Ainnova, Becton Dickinson, Femasys, Histosonics, Innerscope, Nyra, Ventric.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bone Solutions, Mode Sensors.
In the largest med-tech M&A deal in nearly three years, Hologic Inc. agreed to be acquired by funds led by Blackstone and TPG in a transaction valued at $18.3 billion. After five months of rumored negotiations, the outlined deal provides Hologic shareholders with $76 per share in cash plus up to $3 per share in contingent value rights (CVR) to be paid on achievement of revenue goals for the breast health business over the next two years.
San Diego-based Dexcom Inc., is the target of a class action lawsuit in U.S. district court over the company’s G7 continuous glucose monitors, an action which follows a U.S. FDA warning letter by a mere seven months and a recall announced in July, suggesting that litigation often follows other sources of bad news for firms in the med-tech business.
Edap TMS SA signed a €36 million (US$42 million) multi-tranche credit facility with the European Investment Bank, with the first tranche of €11 million expected to be disbursed in early November. The funds will be used to strengthen the company’s balance sheet to support the continued expansion of its Focal One high-intensity focused ultrasound technology in focal therapy and accelerate the development of new clinical indications.
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