The deadline for the new European Medical Device Regulation (EU MDR) is just around the corner. Are you ready? By now, your organization has probably conducted a portfolio review and assessment. You might have even progressed to your Clinical Evaluation Report. But during the assessment process, you may have discovered significant data gaps. You might […]
Medidata Solutions
Connecting the Next Generation of Medical Data and Devices to Improve Patient Outcomes
Every day, hospitals and doctors collect infinite amounts of data on individual patients, diseases and medical procedures. The rise of a new generation of robotic, precision, and surgical devices has created vast stores of video, imaging, and other electronic surgical notes, while the proliferation of digital patient technologies, such as electronic medical records, wearable sensors […]
Dassault Systemes to acquire Medidata for $5.8B
French tech company Dassault Systèmes said today it will purchase health tech firm Medidata Solutions (NSDQ:MDSO) in an all-cash transaction for $5.8 billion on an enterprise value basis or $92.25 per share, slightly lower than yesterday’s closing price of $94.75. The transaction was unanimously approved by the boards of directors of both companies. Dassault Systèmes said the […]
Devices Roar Into The Next Decade
Medical device investments skyrocketed in 2018, and these trends are continuing into 2019. The activity now will influence healthcare for the next decade. This year, the medical device and diagnostic industry saw record-breaking increases in the investment scene. As noted by Silicon Valley Bank’s (SVB) analysis, Trends in Healthcare Investments and Exits 2019, investing in […]
Insulet taps former Medtronic finance exec McMillan as CFO | Personnel Moves – January 8, 2019
Insulet (NSDQ:PODD) said yesterday that it tapped former Medtronic minimally invasive therapies CFO and finance VP Wayde McMillan as its new chief financial officer, replacing Michael Levitz. The Acton, Mass.-based diabetes-focused medtech company said that McMillan will join the company in February and that Levitz will continue as an advisor for a period following the […]
The Promises (and Problems) of Real World Data
By David Kronfeld, Head of Real World Data Innovation, Medidata Solutions Medtech is just starting to access the rich well of real-world data (RWD), which offers some incredible opportunities to build more successful and useful devices. RWD technology can be employed to improve patient recruitment, efficiently deploy a sales team, identify unmet needs in regions, […]
Putting patients first – e-consent in clinical trials
Medical device developers do not always consider the process of informed consent for clinical trials, since it is often handled at the trial site. But the industry is changing, and digitizing processes such as informed consent can streamline studies to rapidly collect quality data, while reducing costs. Patient-centric healthcare means patient-centric clinical trials As the […]
Efficiency, Transparency and Standardization: The Roadmap for Improved Data Collection in Medical Device Clinical Trials
Implementing a unified data platform for medical device trials can yield significant improvements in efficiency, transparency, and standardization, providing resource- and budget-strapped trial teams with accessible, more accurate data for faster, more informed decisions. The era of big data has led to an influx of vast amounts of information coming from disparate sources, causing challenges […]
How an integrated data platform can reshape the medical device industry
As big data grows and competition rises, stricter regulatory guidance looms Today’s medical device industry is being transformed by the generation and analysis of vast amounts of data. However, the traditional approaches to data collection and analyses in clinical trials don’t necessarily apply. Along with this massive volume of siloed, disparate data comes unique challenges […]
Median Technologies inks dev deal with Medidata for cloud-based imaging tech
Median Technologies (EPA:ALMDT) and Medidata said today they inked a collaborative deal looking to leverage their capabilities to streamline the growth and use of medical imaging in cancer clinical trials. Through the deal, Median Technologies will use Medidata’s Clinical Cloud to accelerate oncology medicine development, the companies said. Median will also use Medidata’s Medical Imaging system […]
HeartWare closes enrollment in destination therapy trial for heart pump | Wall Street Beat
HeartWare International (NSDQ:HTWR) completed enrollment in a 450-patient pivotal trial considering its ventricular assist system as a destination therapy for patients with advanced heart failure.
