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Medical Device Lawsuit Alerts
- Acantha LLC v. DePuy Orthopaedics, Inc. et al (JMOL)
- Petition for Inter Partes Review by Auris Health, Inc. et al. of Intuitive Surgical Operations, Inc.’s U.S. Patent No. 6,246,200
- Petition for Inter Partes Review by Nevro Corp. of Boston Scientific Neuromodulation Corp.’s U.S. Patent No. 8,682,447
- Petition for Inter Partes Review by Nevro Corp. of Boston Scientific Neuromodulation Corp.’s U.S. Patent No. 6,381,496
- Petition for Inter Partes Review by Nevro Corp. of Boston Scientific Neuromodulation Corp.’s U.S. Patent No. 7,127,298
Recent Medical Device News
- UCLA launches federally funded innovation hub for medical tech, digital health
- Baxter Announces Acquisition of Cheetah Medical for up to $230M
- Stryker bolsters robotics play with $500m offer for Mobius Imaging
- The 20 largest medical device companies in the world (from MD&O)
- Medical device industry M&A topped $5 billion in July
FDA Issues Guidance on “Abbreviated” and “Special” 510(k) Pathways
By Tom CowanThe U.S. Food and Drug Administration (FDA) has issued two new guidance documents related respectively to an "abbreviated" and a "special" approach to the typical 510(K) process for medical devices. The FDA describes the usual 510(K) process as "a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device...that is not subject to premarket approval." According to the FDA, "Each person who wants to market in the U.S., a Class I, II, and III device intended for human use, f...
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