UPDATED March 16 with comments from panel members. An FDA advisory panel recommended approval for the Absorb bioresorbable stent made by Abbott (NYSE:ABT). The Circulatory Devices panel voted 9-1 on safety, 10-0 on efficacy and 9-0, with one abstention, on the risk-benefit profile for the Absorb device, a coronary scaffold that’s designed to elute the drug everolimus […]
Abbott
Alere slides on Justice Dept. subpoena, late filing
Alere (NYSE:ALR) shares took a hit today after revealing a U.S. Justice Dept. subpoena for documents on its sales practices in Africa, Asia and Latin America under the Foreign Corrupt Practices Act, as it prepared for its nearly $6 billion acquisition by Abbott (NYSE:ABT). The March 11 subpoena asks for documents on Alere’s dealings with 3rd-party distributors and […]
Abbott cautions on potential issue with MitraClip heart implant
Abbott (NYSE:ABT) warned surgeons earlier this month about a potential issue with its MitraClip after receiving 9 reports of problems that led to surgical interventions. In a Feb. 4 urgent field safety notice, Abbott Vascular said the reports indicated that the delivery system for the MitraClip device, which is designed to repair the heart’s mitral […]
Diabetes: Abbott wins CE Mark for FreeStyle Libre flash for kids
Abbott (NYSE:ABT) said today it won CE Mark approval in the European Union for its FreeStyle Libre flash glucose monitoring system for patients aged 4-17. The FreeStyle Libre flash is designed to monitor glucose through a sensor worn on the back of the upper arm for 2 weeks, without the need for the finger prick calibration […]
An acquisition a day keeps the doctor away: Abbott acquires Kalila Medical
Abbott (NYSE:ABT) said today that it acquired Kalila Medical and its Vado steerable sheath for an undisclosed amount. It’s the 2nd buyout in as many days for the Abbott Park, Ill.-based healthcare giant, which yesterday said it plans to pay $5.8 billion for point-of-care diagnostics maker Alere. Kalila, which is based in Campbell, Calif., won 510(k) clearance from […]
Abbott’s Q4 sales, earnings slide
Abbott (NYSE:ABT) today reported 4th-quarter sales and earnings declines but still managed to beat Wall Street’s consensus earnings forecast by a penny. The Abbott Park, Ill.-based healthcare giant posted profits of $767 million, or 51¢ per share, on sales of $5.19 billion for the 3 months ended Dec. 31, 2015, for a bottom-line slide of […]
Abbott wins FDA panel date for Absorb GT1 bioabsorbable stent
The FDA said today that 1 of its advisory panels is due to convene for a hearing on the Absorb GT1 bioabsorbable stent developed by Abbott (NYSE:ABT). The federal safety watchdog’s Circulatory System Devices Panel is slated to meet March 15 for a vote on Abbott’s pre-market approval for the Absorb GT1 device, a coronary scaffold that’s […]
Report: TMVR at least 4 years from U.S. market
Transcatheter mitral valve replacements are at least 4 years out from hitting the U.S. market, despite the $2 billion recently dropped on companies developing the technology by some of the top names in medtech. Medtronic (NYSE:MDT), Abbott (NYSE:ABT), Edwards Lifesciences (NYSE:EW) and HeartWare International (NSDQ:HTWR) in recent months have spent a total of $2 billion to buy […]
VIVA 2015 Roundup: Medtronic touts Valiant stent graft, PAD stent-treatment data
Medtronic (NYSE:MDT) this week presented data from 2 studies of its stent systems and announced a new study of its In.Pact Admiral drug-coated balloon. The announcements were made at the VIVA physicians annual conference in Las Vegas, Nev. The Fridley, Minn.-based medical giant presented data from a 2-year clinical trial of its Valiant Captivia thoracic stent graft […]
Abbott ticks up on Q3 beat, despite slumping device sales
Abbott (NYSE:ABT) shares ticked up today after the company reported a 3rd-quarter sales beat fueled by stronger demand from emerging markets for its generic drugs business, but sales dropped more than -7% for its medical device business compared with Q3 2015. Abbott posted profits of $580 million, or 38¢ per share, on sales of $5.15 billion […]
Layoffs: Medical device makers cut nearly 1200 jobs in California
Medical device companies have enacted layoffs for nearly 1,200 workers in California since the beginning of July, according to the Golden State’s Employment Development Dept., including some of the biggest names in medtech: Alphatec Spine (NSDQ:ATEC) laid off 99 employees at a facility in Carlsbad in early July. Boston Scientific (NYSE:BSX) cut 284 positions in Fremont and another 171 […]