Medical Device Lawsuit Alerts
- Petition for Inter Partes Review by Ivantis, Inc. et al of Sight Sciences, Inc.’s U.S. Patent No. 9,486,361
- Well Cell Global LLC v. Calvit et al. (New Lawsuit Alert)
- Carrum Health, Inc. v. MDsave, Inc. et al. (New Lawsuit Alert)
- Medical Inflatable Exhibits, Inc. v. Atlantic Health Systems, Inc. (New Lawsuit Alert)
- Healthness LLC v. Garmin International, Inc. (New Lawsuit Alert)
Recent Medical Device News
- Siemens to acquire Varian for $16.4 Billion
- Presidio Medical Announces $30 Million Financing Round Led by Invus Opportunities
- Polares Medical Closes a $40M Financing to Complete Pilot Clinical Studies
- CVRx Raises $50 Million in New Equity Financing
- Medtronic Makes Offer for Medical Device Maker Intersect
FDA Publishes Draft Ethical Consideration Guidance to Protect Children Participants in Clinical Trials of Medical Products
By Nima ZargariOn September 23, 2022, the Food and Drug Administration (FDA) published a draft guidance aimed to protect children who participate in clinical trials, titled Ethical Considerations for Clinical Investigations of Medical Products Involving Children. The draft guidance describes the FDA’s current position regarding ethical considerations for clinical investigations of drugs, biological products, and medical devices involving children. The guidance explains the fundamental concepts for the ethical framework that institutional review boards (IRBs), sponsors, and the industry should cons...
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