Limaca Medical Ltd. received U.S. FDA 510(k) clearance for its Precision for gastrointestinal (GI) endoscopic ultrasound (EUS) biopsy device which the company said allows for faster, more efficient and safer collection of tumor tissue samples. The approval follows the receipt of breakthrough device designation, and the deployment of the device into the U.S. market should lead to more efficient and effective diagnosis of GI cancers. Read More
The U.S. FDA is keen on developing policies to guide testing regimes for future pandemics based on the experience with COVID-19, and the FDA’s Tim Stenzel said on a Sept. 8 advisory hearing that automated reporting of at-home tests would clarify questions such as the spread of the pathogen and how well the tests are performing. Stenzel, who is the director of the Office of In Vitro Diagnostics and Radiological Health at the FDA, said the U.S. government agencies have made a number of grants for development of automated reporting mechanisms for at-home tests, signaling an interest on the FDA’s part that automated reporting capabilities will be a priority when the next pandemic strikes.
The heavenly sounds of success lifted Lyra Therapeutics Inc. this week as the company released results from the phase II trial of Lyr-220, a steroid-infused implant designed to provide long-term relief for patients with chronic rhinosinusitis (CRS). Read More
Springboarding off the success of its AI-based imaging software for cancer detection, the deep learning-based artificial intelligence (AI) company Lunit Inc. has another AI software, called the Lunit Scope, up its sleeve for which it hopes to gain U.S. FDA approval by 2025. Read More
Regenerative tissue developer Humacyte Inc. has posted positive top-line phase II/III results for its Human Acellular Vessel, a tissue-engineered graft consisting entirely of decellularized extracellular matrix, for vascular trauma repair. The data showed higher rates of patency, a measure of the lack of vascular obstruction, when compared to synthetic graft benchmarks. Read More
The Medical Imaging & Technology Alliance (MITA) has filed its comments for two draft Medicare rules, citing ongoing concerns over how Medicare pays for a variety of aspects of medical imaging procedures. MITA’s executive director, Patrick Hope, said the Medicare hospital outpatient program is overdue for an overhaul of its packaging policy for payments for radiopharmaceuticals and that the Medicare physician fee schedule should be insulated from further cuts for the professional component of imaging procedures, changes Hope said are necessary to ensure continued patient access to these services. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Agilent, Dexcom, Evolution Optiks, Exact, Medical Components, Neuralace, RBC Medical Innovations, Resolution Bioscience, Signum Surgical, Spectral AI, Sterling Medical, Vantage Medtech. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Insightec, Limflow, Stryker Surgical, Zeta Surgical. Read More
