Device advice was in abundance at today's Food and Drug Law Institute panel discussion on the industry's compliance with promotion and advertising regs, featuring prominent industry lawyers from Medtronic, Covidien, Abbott and law firms.
Treasury Secretary Jacob Lew yesterday unveiled a plethora reforms to make tax inversion more difficult and less attractive, potentially killing a plethora of pending mergers with foreign companies, including Medtronic's $43 billion tie-up with Ireland's Covidien.
Abbott released one-year data of the first randomized controlled trial of 501 patients, comparing its clinical-stage Absorb Bioresorbable Vascular Scaffold to the company's counterpart, the Xience drug-eluting stent, yesterday at the Transcatheter Cardiovascular Therapeutics conference in Washington, DC.
A new study suggests that a diagnostic from Abbott Laboratories offers a more accurate and faster diagnosis of the cause of blood-related infections. The in vitro diagnostic is expected to receive a CE mark in the coming months.
Getting rid of the finger stick for diabetics while maintaining sufficient accuracy without calibration is a long-held industry goal and could prove a boon to patients.
Venture Capital firm Rock Health announced today that it is adding 8 digital health companies to its portfolio and partnering with three industry bigwigs, including Abbott.
Abbott secured Medicare coverage for its MitraClip System to reduce the backward flow of blood through the heart's mitral valve (mitral regurgitation), the company announced Aug. 12. Earlier this month the federal Centers for Medicare and Medicaid services also approved the device for additional reimbursement in the form of new technology add-on payments due to its innovative nature.
Most devices are launched in Europe before arriving in the U.S., and cardiology devices are certainly no exception to the rule. Tough FDA premarket review standards, and the novelty of the technology, have turned the race to sell the first bioresorbable stent in the U.S. into a marathon.
Data from a European postmarket registry show that Abbott's Absorb BVS bioresorbable stent performs at a level similar to today's conventional drug-eluting stents on several measures, but not stent thrombosis. The risk of the stent being blocked by a blood clot was 3.4% after one year, a level of performance similar to prior generation drug-eluting stents, according to a recent EuroIntervention study.
Abbott's medical device revenue was $1.37 billion in the second quarter, an increase of 1.2% year over year. Meanwhile, the diagnostics division reported quarter sales of $1.19 billion, a 4.8% increase, the company revealed July 16.