Pixium Vision SA and Second Sight Medical Products Inc. have inked a definitive agreement through which the former will become the controlling shareholder of the newly combined company. The transaction also will result in the creation of a new entity that will focus on cortical stimulation through Orion. Second Sight is developing that product, which bypasses the diseased eye and could provide a new form of vision. Read More

Nextgen Biomed Ltd. has begun a clinical trial of a breath test to monitor antibody levels in individuals vaccinated against COVID-19. Be'er Ya'akov, Israel-based Shamir Medical Center authorized the trial for test developer Scent Medical Technologies Ltd. (Scentech Medical), which is in the midst of merging with Nextgen. The merged company will be called Scentech Medical. Read More

The U.S. FDA is actively working on guidance for conversion of emergency use authorizations (EUAs) to conventional premarket review programs, but the FDA’s Tim Stenzel said he does “not perceive a need to rush to convert EUAs” because of the volume of EUA applications, and because he does not expect the public health emergency “to end anytime soon.” Read More

PERTH, Australia – Perth-based regenerative medicine company Orthocell Ltd. received marketing clearance from Australia’s Therapeutic Goods Administration (TGA) for its Celgro collagen medical device for dental guided bone and soft tissue regeneration applications. The approval validates the Celgro platform technology and clears the way for further approvals in nerve and tendon repair, Orthocell CEO Paul Anderson told BioWorld. Read More

A new imaging technology that uses transmission ultrasound to provide a 3D image of breast tissue outperformed traditional digital mammography in a recent retrospective analysis. The study findings could set the stage for the U.S. FDA to clear the technology for breast cancer screening in young, high-risk women. Read More

New hires and promotions in the med-tech industry, including: Dermtech, Halo Health, Nanomedic Technologies. Read More

Med-tech firms raising money in public or private financings, including: Adapthealth, Corwave, Neogenomics, Titan Medical. Read More

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Mitre Medical, Neurolief, Sensory Cloud. Read More

Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Advanced Oncotherapy, Apex Family Medical, Bioclinica, Biodesix, Bio-Techne, Biotheranostics, Bioventrix, Carmat, Change Healthcare, Cssi Lifesciences, Diamedcare, Fathom Consulting, Fresenius Kabi, Helix Opco, Helius Medical Technologies, Hologic, Illumina, Medacuity, Monteris Medical, Nephros, Novasep, Optimuminsight, Pointclickcare, Rewalk Robotics, Saliency, Sartorius, Scaleready, Seegene, Sequans Communications, Skylight Health, Tonic Bioventures, Withings, Valgenesis. Read More

Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Northstar Medical Radioisotopes, Spectrum Solutions, Ultromics. Read More

The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA grants EUA to Quanterix for Simoa test; EC investing in startups; Alternatives to animal testing a challenge; USPTO seeks more uniformity between PTAB, courts; NICE nods to Olympus Plasma for BPH. Read More

Keeping you up to date on recent developments in orthopedics, including: Discovery of aging mechanism for hematopoietic stem cells; Long-term study finds dozens of new genetic markers associated with lifetime bone growth; Living alone may increase risk of dying after hip fracture; Bone fracture risk may increase when critical enzymatic processes decline. Read More