Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: GE Healthcare, Inogen, Lunit, Motif Neurotech, Myriad, Physio-Assist.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: B.Braun, Cerevasc, Vonco, Ossdsign.
Chronic rhinitis is drawing more attention from medical device makers in recent years, with solutions including cryotherapy and temperature-controlled radiofrequency disruption of posterior nasal nerves to halt the condition.
Insightec Ltd. broadened its CE mark approval for the Exablate Neuro, a focused ultrasound platform which treats essential tremors, to allow patients to have their second side treated. With some 60 million people estimated to be affected by essential tremor globally, Insightec hopes that with both sides treated, patients will have full body relief from tremor and therefore be able to resume everyday activities.
Choosing blastocysts for transfer based on size could give prospective parents a much better chance of success in welcoming a new member to the family, a study published in the Nature portfolio journal Scientific Reports demonstrates.
The U.S. FDA has broken out of the summer guidance doldrums in fine form, inking a series of nine draft and final guidances in the first half of September alone. The latest bolus includes a revised version of a guidance for the breakthrough devices program and two draft guidances for devices for weight loss, giving industry plenty to mull over as the final days of fiscal year 2023 trickle away.
Med-tech deal values continued their upward swing, increasing nearly 90% from last year. Med-tech M&A volume and value remained in a slump compared to the previous two years, though values are higher than 2020.