Abbott

Abbott launches smartphone compatible insertable cardiac monitor

Tuesday, October 24, 2017

Abbott has secured FDA clearance for the Confirm Rx Insertable Cardiac Monitor (ICM), the world’s first and only smartphone compatible ICM designed to help physicians remotely identify cardiac arrhythmias. With FDA clearance Abbott can now provide U.S. patients a new way to monitor for abnormal heart rhythms while staying connected to their physician remotely and being able to engage in their healthcare.

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Changes needed for EDC to show true efficiency

Monday, October 2, 2017

Three quarters of clinical trial managers report challenges loading data into their EDC systems, which in turn increases the time it takes to build study databases and then delays trials.
Eighty-three percent of life sciences organizations release a clinical database after the first patient, first visit. It takes an average of 68 days to build and release a clinical study database, which contributes to an increase of nearly a month downstream in the completion of a trial.

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Report: Global medtech sales forecast to reach $522B by 2022

Tuesday, September 26, 2017

The “EvaluateMedTech World Preview 2017, Outlook to 2022” report from life science commercial intelligence firm Evaluate, reveals Medtronic was the leading medtech company in 2016 with sales of almost $30 billion and will retain the crown in 2022, with sales forecast to reach $37.7 billion. Abbott to jump to 3rd place as its acquisition of St. Jude creates the world’s second largest cardiology company.

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Abbott addresses pacemaker hacking fears

Tuesday, September 5, 2017

On August 23, 2017, the FDA approved a firmware update that is now available and is intended as a recall, specifically a corrective action, to reduce the risk of patient harm due to potential exploitation of cybersecurity vulnerabilities for certain Abbott (formerly St. Jude Medical) pacemakers. “Firmware” is a specific type of software embedded in the hardware of a medical device (e.g. a component in the pacemaker).

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FDA approves Idhifa for relapsed or refractory acute myeloid leukemia

Wednesday, August 2, 2017

The FDA approved Idhifa (enasidenib) for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) who have a specific genetic mutation. The drug is approved for use with a companion diagnostic, the RealTime IDH2 Assay, which is used to detect specific mutations in the IDH2 gene in patients with AML.

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An exciting year for the medical technology industry

Monday, December 19, 2016

The Pulse on Global Trials by Matthew Howes

In the medical technology industry, 2016 has been an exciting year for R&D. From the development of naturally moving prosthetic limbs that are controlled by the brain to the use of a needle-free vaccine delivery device in Zika trials, medical devices are becoming a major focus in the advancement of human health.

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Syngene International commissions dedicated R&D center for Amgen

Thursday, September 8, 2016

Syngene International, one of Asia’s largest R&D-focused CROs, has announced the establishment in Bangalore, India, of an integrated, multi-disciplinary drug discovery and development center for Amgen. This center, named Syngene Amgen R&D Center (SARC), will be Syngene’s fourth such exclusive R&D center. Syngene already operates dedicated R&D centers for Bristol-Myers Squibb, Abbott Nutrition and Baxter.

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