Royal Philips NV is reporting the launch of Philips Ventilator Bipap A40 EFL, a noninvasive ventilator that aims to help patients with chronic obstructive pulmonary disease (COPD) breathe easier. With its CE mark in hand, the company has tagged initial target markets as France, Italy and the U.K. Additional European markets are expected to come next year. Read More
By analyzing patients’ reactions to treatment, Oncohost Ltd.’s proteomics-based platform enables earlier prediction of paradoxical responses to immunotherapy that promote tumor growth in certain cancers. The artificial intelligence-powered host response profiling platform, called Prophet, could help identify the best combination of therapies and minimize adverse effects from treatments that are unlikely to be beneficial. Read More
The U.S. FDA’s stated policy is that it will not review emergency use authorizations (EUAs) for lab-developed tests (LDTs) for the COVID-19 pandemic, but that doesn’t mean labs are completely shut out. The FDA’s Toby Lowe said that a lab that wants to pair an assay that already has an EUA with a new software installation on lab instrumentation can work with the assay developer to update that EUA. Read More
LONDON – The U.K.’s influential health technology assessment body, the National Institute of Health and Care Excellence (NICE), is consulting stakeholders on proposed changes to how it selects medical devices, diagnostics and drugs for evaluation. Read More
Haemonetics Corp. reported sales of $209.5 million for the second quarter of fiscal year 2021, down 17.1% from the same period the prior year. Plasma sales declined 32.4% year over year to $78.4 million in the face of continuing COVID-19 impacts on blood donor activity. As Jeffries analyst Anthony Petrone observed, “Trough is rear view but plasma headwinds still elevated” through the period ended Sept. 26, “though declines were lower than expected (actual -30%; JEF -28% cc).” Read More
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: HHS plans retrospective regulatory review. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Applied UV, Axsome Therapeutics, Clinical Laserthermia Systems, Digirad, Electromedical Technologies, Energetic Wellness School of Naturopathy, The Feinstein Institutes for Medical Research, Mimedx, Novan, Ontrak, Stryker, Thermo Fisher Scientific, Toyoda Gosei, Wright Medical Group. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Sensetime. Read More
Keeping you up to date on recent developments in orthopedics, including: New opportunities for detecting osteoporosis; Brazilian researchers discover how muscle regenerates after exercise; Different outcomes by race/ethnicity among patients with COVID-19 and rheumatic disease. Read More
