Biotech titan Roche secured a landmark FDA win with clearance for its Accu-Chek Aviva Expert blood glucose meter, the 1st of its kind with a built-in insulin calculator to help guide patient therapy.
Biotech titan Roche acquired Boston, Mass.-based medical device company Constitutional Medical Investors for a reported $220 million plus possible milestones.
MASSDEVICE ON CALL — The FDA this week officially approved Swiss healthcare giant Roche‘s COBAS INTEGRA 800 Tina-quant HbA1cDx assay as a test for diabetes.
The test has been in use as a diagnostic tool off-label, but has been officially marketed only as a means of monitoring blood glucose control.
The meter and pump can seamlessly transmit data back and forth via Bluetooth, allowing for remote insulin delivery and providing guidance on dosage levels.
MASSDEVICE ON CALL — Med-tech industry lobby AdvaMed had some words of inspiration for lawmakers looking to mark up the latest iteration of the Medical Device User Fee Act this week.
"Mark up is an important milestone in the reauthorization process, and we are encouraged by the bipartisan support this legislation has received," AdvaMed chairman & CEO Stephen Ubl said in a prepared statement. "We are hopeful it will remain on track to pass in a timely fashion."