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Clinical Trials

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Augmenix Looks To Apply Hydrogel Technology Beyond Prostate Cancer

The company's SpaceOAR injected hydrogel spacer continues to prove effective at reducing the collateral damage from radiation treatment for prostate cancer. Now the Boston company hopes to apply the same bioabsorbable hydrogel technology to improve outcomes with radiation therapy for other cancers, including pancreatic and gynecological cancer.

Clinical Trials Innovation Research & Development
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Device Week, October 19, 2017 – IVD Updates, And Watchman Scrutiny

On this week's podcast, we highlighted progress by several startups in the molecular diagnostics space, and discussed growing scrutiny in the cardiology community of Boston Scientific's Watchman stroke device.

Clinical Trials Innovation

NIH/Industry Oncology Partnership Aims For Immunotherapy Biomarkers

The US National Institutes of Health will team up with 11 different drug-makers to explore new biomarkers with a vision of precision oncology medicine.

Research & Development Personalized Medicine

Patients Want Industry To Minimize Burdens, Augment Comforts Of Device Trial Participation

Patients and patient advocacy groups at the US FDA's inaugural Patient Engagement Advisory Committee meeting said they need sponsors to minimize the burdens and augment the comforts of trial participation, and get reports on outcomes along the way. Meanwhile, industry groups worried about revealing too much confidential business information, and biasing trial outcomes.

Advisory Committees Clinical Trials

Canada Prepares To Publish Draft Rules On Release Of Clinical Data

Following a public consultation earlier this year, Health Canada has asked for expert advice on its plans to allow the release of clinical data that is currently considered confidential. It expects to publish draft regulations this autumn.

Clinical Trials Canada

OBD's Epigenetic Biomarker Tech Shows Ethnicity Issue-Free Dx Potential

Recent studies completed by epigenetic biomarker company Oxford BioDynamics have shown the company's platform technology EpiSwitch can diagnose and stage breast cancer and Amyotrophic Lateral Sclerosis (ALS). The Oxford spinout is the developer of a blood-based platform test for detecting chromosome confirmation signatures (CCSs), which overcome any ethinicity issues.

Clinical Trials Companies

Starts & Stops: Abbott, Medtronic Announce Major Trial Activities

Starts & Stops is a regular feature highlighting Medtech Insight editors' picks of noteworthy medtech clinical trial announcements, initiations, completions, and suspensions each month. This edition includes entries from a variety of companies and technologies, including many post-market studies following regulatory approvals.

Starts & Stops Clinical Trials

US FDA Approves Medtronic's HVAD For Destination Therapy

The expanded labeling gives Medtronic's HVAD, acquired when it bought HeartWare last summer, the same indication as Abbott's HeartMate II ventricular assist device.

Approvals Clinical Trials

Using Surrogate Samples For IVD Trials: MDIC Issues A Framework

The group that helped developed a framework to incorporate patient preference data into regulatory device submissions has released a new document to help in vitro diagnostics sponsors tackle the problem of limited sampling by using surrogate samples. The plan has been reviewed by top FDA officials.

In Vitro Diagnostics Regulation

Positive Long-Term Data Plug Doubts Over PFO-Closure Stroke Benefits

Data from the REDUCE, CLOSE, and RESPECT trials, published in the New England Journal of Medicine, showed that closing a patent foramen ovale with a percutaneous closure device can reduce the risk of ischemic stroke in patients who have already had a cryptogenic stroke. Observers believe these trials showed a benefit of PFO closure in this population after previous trials failed to show a benefit largely because they did a better job of only selecting patients most likely to benefit.

Cardiovascular Cardiology
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