Tm Bioscience Hopes To Snare Large Laboratories With Automated Tag-It Test
This article was originally published in The Gray Sheet
Executive Summary
Genetic test developer Tm Bioscience is banking on the improved throughput of an automated version of its genetic Tag-It cystic fibrosis kit to attract interest from the largest U.S. commercial clinical laboratoriesYou may also be interested in...
FDA Clears Tm Bioscience Cystic Fibrosis Gene Test Via De Novo
Impella Safety Update: Data Supports Pump For Qualified Patients
Updated data from a postmarket study of Abiomed’s Impella RP right-heart pump further supports the device’s safety for a specific patient population.
Quality, Safety, MDSAP A Focus For Medtech In New USMCA Trade Agreement
The new US-Mexico-Canada (USMCA) trade agreement includes language on enhancing regulatory compatibility between the three countries by recognizing quality systems audits performed under the Medical Device Single Audit Program (MDSAP). It also stipulates that each trading partner “consider its resources and technical capacity” in ensuring the safety, effectiveness and quality of devices – and more. Medtech industry advocacy group AdvaMed is praising the deal, reached by the three countries on 10 December.
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: