Establishment Labs Holdings Inc. presented remarkably positive results at three years for its Motiva silicone breast implant at The Aesthetic Meeting 2023 in Miami on April 20. In keeping with the two-year results previously presented, the data demonstrated very low rates of device failure or contracture, which have plagued other implants. The strength of the investigational device exemption study makes an approval from the U.S. FDA ever more likely. Read More
Biocartis Group NV recent entered an agreement with Apis Assay Technologies Ltd. to develop Apis’ breast cancer subtyping assay on its Idylla platform, is part of the Belgium company’s mission to bring complex molecular testing to as many patients as possible, outgoing Biocartis CEO Herman Verrelst, told BioWorld. The Idylla platform is a fully automated, real-time PCR based molecular testing system. With the technology failing to penetrate the U.S. market, and the share price tanking in recent years, the Belgium-based company recently appointed Roger Moody to the top job, effective Apr. 24, 2023. Read More
The U.S. Supreme Court has handed down a broadly unanimous decision that allows the targets of Federal Trade Commission (FTC) enforcement action to appeal that action to federal district court prior to the conclusion of the agency’s review or enforcement process. The outcome could prove a boon to life science companies that may now challenge FTC actions against mergers and acquisitions prior to the conclusion of that action, a point at which the company’s options have narrowed drastically. Read More
Reach Neuro Inc. has been granted FDA breakthrough device designation for a rehab platform that delivers small electrical impulses to the spinal cord to help restore shoulder, arm and hand movement to individuals suffering from chronic stroke. The company said Avantis restores a patient's ability to control movement, not only giving the patient immediate relief, but making it possible to return to therapy and continue making even further improvements. Read More
The amount of money raised by med-tech companies in the first quarter (Q1) of 2023 is the lowest amount raised for the industry during any quarter going back to 2018. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Establishment Labs, Know Labs, Mindpeak, Paragonix Technologies. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Active Implants, Aptitude Medical, Aziyo, Beacon Biomedical, Boehringer Ingelheim, Emit Imaging, Lemaitre Vascular, Neracare, Retinai, Skylinedx, Watkins-Conti. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Uromems. Read More
