Preliminary results from a trial demonstrated that Science Corp.’s Prima retina implant restored ‘form vision,’ including the ability to read in patients with vision loss. Originally developed at Stanford University and then advanced by Pixium Vision SA, Prima received U.S. FDA breakthrough device designation in April 2023.
The U.K.'s Medicines and Health Care Products Regulatory Agency posted a series of draft new regulations that will increase the requirements for device makers doing business in the U.K.
New hires and promotions in the med-tech industry, including: Accuray, Axxess, Catalyst Orthoscience, Gradient Denervation Technologies, Grail, Know Labs.
The U.S. FDA declared that Michelle Tarver is the permanent replacement for Jeff Shuren as the director of the agency’s device center. The news is hardly a surprise as Shuren confirmed the appointment in an October 2024 public meeting.
Baxter International Inc., whose North Cove manufacturing site in Marion, North Carolina, was significantly impacted by the rain and storm surge from Hurricane Helene – including flooding of the facility – in September, reported that restoring the physical facilities has exceeded its expectations, with meaningful advances in site cleanup and remediation.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: 3X4 Genetics, Access Genetics, Autonomix, Bioinformatics Solutions, Capsulomics, Danaher, Digital Health Navigation, Echolight, Envoy, Gradient Denervation Technologies, Healthlynked, Lin Health, LISA, Mayo Clinic, Mpath Health, Neuraxis, Novastep, Osteotec, Oraldna Labs, Previse Dx, Sciex, Sensible Diagnostics, Twist.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Eptiel, Irhythm, Peytant.
The U.K. National Institute for Health and Care Excellence endorsed the Qb Test by Qbtech AB of Stockholm to aid in diagnosis of attention deficit/hyperactivity disorder in those aged 6 to 17.
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