Medtronic's Melody, Harmony transcatheter pulmonary valves show gains in congenital heart disease (Fierce)
Zebra Medical Vision wins FDA clearance for AI to predict osteoporosis (MassDevice)
Class 1 Device Recall StealthStation DBS Software Nexframe AutoRegistration (FDA)
Government & Regulatory
Essential work to combat the COVID-19 pandemic to continue during EMA's closure from 21 to 22 May 2020 (EMA)
COVID-19: It’s a Threat. And It’s Material (FDA Law Blog)
German Lab Accused Of Illegally Selling Tick Test Kits In US (Law360)
USPTO Announces COVID-19 Prioritized Examination Pilot Program (Patent Docs)
Dr. Reddy's $9M Deal Gets Nod In Quality Control Suit (Law360)
Regulation of stem cell treatments: information for practitioners (TGA)
Regulatory Recon is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe.
A story's inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.
We have completed our migration to a new platform and are pleased to introduce the updated site.
What to expect: If you have an existing login, please RESET YOUR PASSWORD before signing in. After you log in for the first time, you will be prompted to confirm your profile preferences, which will be used to personalize content.
We encourage you to explore the new website and visit your updated My RAPS page. If you need assistance, please review our FAQ page.