New hires and promotions in the med-tech industry, including: Dariohealth, Gen Incode, Ibex Medical Analytics, Neuroone, Paragon 28, Si-Bone, T2 Biosystems.
Keeping you up to date on recent developments in diagnostics, including: Retinal imaging may detect Parkinson’s disease; Biomarkers may differentiate psoriatic arthritis, osteoarthritis; ApoE multitasks for regulating brain lipids.
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.
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.
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.
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.
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.”
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.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Northstar Medical Radioisotopes, Spectrum Solutions, Ultromics.
RSS
