Latest from Elizabeth Orr
Attorneys with law firm Gibson Dunn believe that fewer investors will be investigated for False Claims Act violations under the incoming Trump administration but expect other policy to go full steam ahead.
This week, renal denervation systems from Medtronic and Recor won Medicare coverage; Boston Scientific bought cardiac-mapping firm Cortex; Veravas and Phanes Biotech teamed up on an Alzheimer’s diagnostic; and more.
New guidelines from the Medical Device Coordination Group explain the policies used by the EU in regulating ethylene oxide for device sterilization.
Patients treated with Abbott’s Esprit BTK system had better results and fewer repeat procedures after two years than a control group, the company announced this week. Abbott vascular leader Jennifer Jones-McMeans spoke with Medtech Insight about what the results could mean for patient care.
This week, HistoSonics announced it will bring its ultrasound system for destroying liver tumors into VA hospitals, Edwards Lifesciences reports encouraging TRISCEND II trial results at TCT, study finds blood test for CRC screening are less cost-effective than alternatives, and more.
Clinical labs and diagnostics firms alike are still grappling with the likely impact of the FDA’s final rule on LDTs, speakers said in a recent webinar. Key areas of concern: The potential for lab consolidation, lack of clarity on when clearance is necessary, research-use tests, and the hesitation imposed by an ongoing lawsuit and upcoming election.