MDDI Online

Integra Adds Depth to Neurosurgery Unit with Rebound Deal

The Rebound buy helps enhance Integra’s $1.05 billion acquisition of the Codman Neurosurgery business. Integra picked up the company in 2017 from Johnson & Johnson.

FDA Has Calmed Down About Paclitaxel, but Has the Market Recovered?

Paclitaxel-coated balloons and paclitaxel-eluting stents caused quite the stir for the drug-coated balloon manufacturers and physicians this year, but there does seem to be some signs of a rebound in the market. The issue was a hot topic last week at Wells Fargo Securities' annual healthcare...

How to Keep a Big Integration on Track

During a recent earnings call, Stryker management shared some insight into what lessons the company has learned over the years that led to the successful integration of K2M.

Abbott Shines Light on “Forgotten Valve” with New Pivotal Trial

The Abbott Park, IL-based company has launched an IDE of the TriClip, a transcatheter tricuspid valve repair system for the treatment of severe tricuspid regurgitation (TR). Jason Mills, an analyst with Canaccord Genuity points out there are a handful of devices that could help define the TR repair space.

7 Considerations for Choosing a Testing Partner

Expectations for medical device testing are changing, thanks to evolving regulations and standards as well as other factors. Finding the right testing partner is critical for success, so here are a few points to consider.

Weigh In on FDA's Weight-Loss Device Paper

Previously FDA-approved weight-loss devices are all indicated for “weight loss.” However, under the concept being proposed in FDA's discussion paper, future medical devices intended for weight loss may have indications that are more specific to the measured benefit, such as “short-term limited...

Tips for When to Consider Legal Review of Quality System Investigations

An industry expert said that a good manufacturing practice lawyer is the right person needed to review a challenging, sticky manufacturing investigation.

OncoCyte Spells Out the Acquisition Plan for Razor Genomics

The Alameda, CA-based company said the deal could help it boost its lung cancer detection offerings.

Supplier Stories for the Week of September 1

Here’s what was new in the world of medical device suppliers during the week of September 1.

Soft, Stretchable Health Monitor Eyed for Long-Term Use

One of the key challenges researchers aim to overcome with wearable technology to is to make it more comfortable for the user while still being able to perform and transmit data effectively. A team at the Georgia Institute of Technology (Georgia Tech) has made strides in this area with the...

Single-use plastic bottles find second life in prosthetic devices

How do you slash the cost of a prosthetic limb socket from approximately $6,000 to around $12? Simple: You fabricate it from plastic water bottles, and strike a blow against plastic waste in the process. The idea originated with Dr. Karthikeyan Kandan, a senior lecturer in Mechanical Engineering at...

Patent Considerations for Connected Medical Devices

An industry expert discusses why developing new solutions, IoT, and blockchain must be important components of a medtech company’s strategic planning.

Shockwave Gets a Little Pep in Its Step with Breakthrough Device Designation

The Santa Clara, CA-based company, which raised $110 million in an IPO in March, is developing technology that uses sonic pressure waves in order to facilitate stent delivery, deployment, and optimal expansion, thereby improving blood flow to the heart muscle.