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Home » Newsletters » BioWorld MedTech

BioWorld MedTech

Aug. 23, 2023

View Archived Issues
Recor Medicaal Paradise renal denervation catheter

Recor snares supportive vote from FDA advisory panel for Paradise renal denervation device

The age of renal denervation as a treatment for hypertension may have finally arrived in the U.S. with the affirmative U.S. FDA advisory vote for the Paradise system for renal denervation by Recor Medical Inc., of Palo Alto, Calif. The 12-member advisory committee vote unanimously that the data suggested the ultrasound-based device was safe and voted 8-3 in support of the Paradise’s efficacy, an outcome that the agency may find difficult to refute, given the large public health impact of hypertension in the U.S. Read More
Levita Magnetics’ MARS system

FDA gives Levita a lift to MARS with surgery system clearance

Levita Magnetics International Corp. received uplifting news this week as the U.S. FDA cleared its magnetic-Assisted Robotic Surgery (MARS) minimally invasive surgical platform. MARS builds on the company’s first product, the Levita magnetic surgical system, by providing greater control of surgical instruments to surgeons. The platform is cleared for use in bariatric, colorectal, gallbladder and prostate surgeries. Read More
Mindrhythm's headset

Headset could improve safety of return-to-play decisions after concussion

For many sports injuries, return-to-play decisions are pretty straightforward: pain and swelling have dissipated, or an X-ray confirms that a bone has healed. For concussion, it’s not so clear. Though symptoms may resolve after a few days, the brain could still be vulnerable. Now, Cupertino, Calif.-based based startup Mindrhythm Inc. has developed a headset to assess concussion recovery using biometric measures and help doctors safely return concussed individuals to play. Read More
Sycamore device from Safe Orthopaedics

Safe Orthopaedics unveils promising device for vertebral compression fractures

Safe Orthopaedics SAS reported results from a biomechanical study comparing its new surgical technique Sycamore – a pedicle-anchored implant – with standalone balloon kyphoplasty. The results published in summer 2023 in the Journal of Experimental Orthopaedics showed a “significant increase” in compression strength with patients using Sycamore. Read More
stem-cells

Stem cell study functionally links Alzheimer’s risk genes

Investigators have functionally linked the Alzheimer’s disease (AD) risk gene SORL1 to apolipoprotein E (ApoE) and clusterin, another apolipoprotein. The work, Tracy Young-Pearse told BioWorld, is part of an attempt to “try to understand different subtypes of Alzheimer’s disease.” It maps some of what Young-Pearse termed the “many molecular roads that lead to Alzheimer’s” – which, in turn, is the first step to setting up roadblocks. Young-Pearse is an associate professor in the Ann Romney Center for Neurologic Diseases at Brigham and Women’s Hospital and Harvard Medical School and co-leader of the Harvard Stem Cell Institute’s Nervous System Diseases Program. She is also the senior author of the paper describing the findings, which appeared online in Cell Reports on Aug. 22, 2023. Read More

US FTC taps Covington’s Liu for director of Bureau of Competition

The U.S. Federal Trade Commission has picked Henry Liu of the law firm of Covington & Burling to run the agency’s Bureau of Competition, a seat that was vacated earlier this year when Holly Vedova retired. Read More

Appointments and advancements for Aug. 23, 2023

New hires and promotions in the med-tech industry, including: Clarimed, Vitrolife. Read More

Financings for Aug. 23, 2023

Med-tech firms raising money in public or private financings, including: Shoulder Innovations. Read More

Other news to note for Aug. 23, 2023

Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aquedeon Medical, Cydar, Electrocore, Johnson & Johnson, Kenvue, Medtronic, Myriad Genetics, Nanovibronix, Recor, Theken, Tivic, Trisol, Visionair Solutions. Read More

Regulatory actions for Aug. 23, 2023

Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Fresenius, Geneseeq, Pixcell, Sparrow Bioacoustics, Telesair. Read More

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