By Michelle Tarver MD PhD – For five decades, the 1976 Amendments have served as the foundation of a regulatory framework designed to protect patients while advancing innovation. It has ultimately helped to ensure that medical devices are safe, effective, and high-quality for the people who rely on them.
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In this monthly report you will find news and highlights in the Applied Life Sciences from CMS, OFD Life Sciences, Perceptive eClinical, iPerf, Relaxera, BIOTRONIK, Verana Health, Matricelf, Touchlight, neuroClues, BSM Biotech, Neurizon Therapeutics Limited, Biotium, Quintessence Biotech, Kupando, and more.
By Daniel Caños PhD MPH & Michelle Tarver MD PhD – Today’s health care ecosystem is generating richer and more diverse data streams, providing new opportunities to modernize how Real-World Data generates relevant and reliable Real-World Evidence. The FDA is working to provide clearer recommendations and more consistent acceptance of RWE as valid scientific evidence.
In this monthly report you will find news and highlights in the Applied Life Sciences from BioMed X, ConcertAI, UCSF, Michigan Integrative Health Stem Cells, Kandu, Biotium, PhaseV, Freudenberg Medical, Vetter, MetP Pharma AG, Hemex Health, ONWARD Medical and more.
By Arthur Allen – While the FDA is streamlining regulation of copycat versions of the expensive drugs that millions take for arthritis, cancer, and other diseases, the U.S. patent office is making it harder for the cheaper medicines to get on the market, industry officials say.
The U.S. Food and Drug Administration is announcing a public meeting to discuss proposed recommendations for the reauthorization of the Medical Device User Fee Amendments (MDUFA) for fiscal years 2028 through 2032. The current legislative authority for MDUFA expires on Sept. 30, 2027.
Health IT product news from Motive, Auxira Health, Wolters Kluwer Health, Verato, Cantata Health Solutions, 1upHealth, Wisp, ConneXor Community, Curative, Experity, HerMD, FDA, Huma Therapeutics, Amplity, Ambience Healthcare, TalkDesk, Intelerad Medical Systems, SurgiQuality, Testsigma, Tempus AI, Andor Health, Relatient and more.
This month’s AI report includes news and updates from Sword Health, TeleTracking, Palantir, Pacific AI, Coalition of Health, H1, Veda, ArcheHealth, Lumeris, Biostate Ai, SurgiQuality, Huma, FDA, Amplity, Ambience Healthcare, Experity, Talkdesk, Cognizant, & more.
The “Make Our Children Healthy Again Assessment” report exposes a range of contributing factors—including poor diet, accumulation of environmental toxins, insufficient physical activity, chronic stress, and overmedicalization.