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Medical Devices

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Bioclinica: more stakeholders pushes need for collaboration

22-Feb-2017 - Bioclinica has expanded its eHealth App xChange to make a greater range of technologies available to the increasing number of industry stakeholders – many with differing priorities. 

iCardiac eCOA platform a 'major step forward,' says CEO

22-Feb-2017 - iCardiac’s new eCOA platform, QPoint, can measure clinical outcome assessments from patients at home or during site visits and will soon integrate with emerging wearables.

SGS expands E&L testing services at New Jersey facility

26-Jan-2017 - SGS SA has expanded its Extractables and Leachables testing services with new equipment and specialist analysts at its facility in New Jersey, US.

Belgian CDMO to launch generic of vaginal contraceptive device NuvaRing

24-Jan-2017 - Mithra Pharmaceuticals SA will seek US and EU approval for a rival to the NuvaRing contraceptive device in Q2, manufacturing the ring through its independent CDMO platform.

CRF Health receives FDA clearance for next-gen wireless glucometer

19-Jan-2017 - The next-generation wireless glucometer provides rapid testing results on the company’s eCOA platform for clinical trials.

Feature

The rise of 'technology-enabled' clinical research companies

17-Jan-2017 - Technology is catapulting clinical trials into a 'new era' as scientific breakthroughs bring new opportunities to an industry that has traditionally lacked innovation.

CROs not ready for wearable tech? Report examines use in clinical trials

30-Nov-2016 - Wearable technology has been making inroads in the clinical trial industry, however several challenges and concerns surrounding lack of experience still stand in the way of increased adoption.

Product recall after mechanism failure complaints

Teleflex recalls faulty nasal delivery devices used to administer opioid overdose meds

10-Nov-2016 - Teleflex Medical Corp. has recalled devices used to deliver rescue therapies to people who have overdosed on opioids, following complaints of mechanism failure leading to a "public health crisis".

CiToxLAB acquires preclinical medical device CRO

08-Nov-2016 - CiToxLAB has acquired AccelLAB, a preclinical medical device contract research organization (CRO) as the industry works to align the development of new drugs and medical devices.

CSSi LifeSciences launches fully integrated medical device CRO

07-Nov-2016 - CSSi LifeSciences has launched its fully integrated medical device contract research organization (CRO) as an alternative to “traditional ‘big-box’ CROs.”

Early stage clinical trials get boost from modern EDC platform

02-Nov-2016 - Litmus Health imagines a future where all the world is “one big clinical trial,” and as the first step, it has launched its clinical data science platform into public beta.

Q2 Solutions: CDx strategy to improve sponsor success

01-Nov-2016 - The global clinical trials laboratory services organization, Q2 Solutions , is expanding its genomic companion diagnostics (CDx) capabilities through a new collaboration.

Virtual clinical research company seeks to bring clinical trials in-home, secures $31m

20-Oct-2016 - Science 37 has raised $31m in Series B financing to support its end-to-end decentralized clinical trial services and technology platform.

How can patient-generated health data be best delivered?

20-Oct-2016 - Validic and Sutter Health are collaborating on a federal pilot project that seeks to determine how patient-generated health data can be best delivered to researchers.

Medical device CRO expands footprint to meet growing demand

11-Oct-2016 - IMARC Research, an Ohio-based contract research organization (CRO), has expanded its footprint in the medical device market with a new office in Minneapolis, MN.

Smart injector allows for in-home injections

10-Oct-2016 - QuiO has raised $1.05m to develop its real-time adherence monitoring solution for injectable therapies – a device which could allow CROs to monitor injection events remotely. 

Survey: 97% plan to use digital health tech in trials over next five years

21-Sep-2016 - Digital health devices are increasingly being used by the industry to collect patient-generated data in clinical trials and improve medication adherence – and adoption is expected to increase.

Needle-free tech company partners with WHO as part of polio eradication effort

01-Sep-2016 - PharmaJet has inked a multi-year deal with the World Health Organization for its needle-free technology, which uses 80% less vaccine than traditional methods.  

MassBio: drug development pipeline, candidates in clinical trials on the rise

30-Aug-2016 - As more Massachusetts companies reach clinical trials, demand for biomanufacturing services in the state is increasing, says report.

Adaptive designs: patient value and commercial benefits

17-Aug-2016 - As regulators push the industry to adopt adaptive studies to reduce risk to both patients and manufacturers, the FDA has finalized a guidance outlining key issues and recommendations.

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