The latest global regulatory news, changes and updates affecting medical devices and technologies, including: CDC reports on cases, sequencing; NICE says savings seen with Cytosorb; IP at issue as WTO pushes for global pandemic effort; Researcher gets prison time for trade secret theft; USPTO responds to COVID-19 challenge.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA grants EUA to Quanterix for Simoa test; EC investing in startups; Alternatives to animal testing a challenge; USPTO seeks more uniformity between PTAB, courts; NICE nods to Olympus Plasma for BPH.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: USPTO finalizes SAS rule, U.S. senators press case for permanent telehealth, CMS no fan of national coverage policy for Allomap, TGA posts guidance for class I tests, Marburg MCMs protected under PREP.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: New notified body for IVDs brings total to five; U.S. securities compliance not optional for foreign companies; USPTO touts early results of amendment pilot.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: WHO targets cervical cancer; More time to comment on instituting PTAB trials.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: NICE reviews Dexcom’s G6; Ortho claims EUA for antigen test with 100% sensitivity.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Advisory hearing gives Neovasc Reducer poor marks for efficacy; CMS eyes expanded DME coverage of CGMs; APEC launches Vision 2025 for business ethics; Innovation Alliance voices support for Iancu, PTAB changes.
The U.S. Patent and Trademark Office (PTO) has posted a notice of proposed rulemaking in response to a case decided by the Supreme Court in 2018, SAS v. Iancu, and the first item on the PTO agenda is to formally require that an inter partes review (IPR) consist of an exhaustive review of all the claims contested by the petitioner.
The U.S. Patent and Trademark Office (PTO) has posted a notice of proposed rulemaking in response to a case decided by the Supreme Court in 2018, SAS v. Iancu, and the first item on the PTO agenda is to formally require that an inter partes review (IPR) consist of an exhaustive review of all the claims contested by the petitioner.
