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Thermography Is Not an Alternative for Mammography, FDA Warns

FDA is alerting women, healthcare providers, and others getting breast cancer screening that thermography is not an effective alternative to mammography and should not be used in place of mammography for breast cancer screening or diagnosis.

The agency said there is no valid scientific data to demonstrate that thermography devices, when used on their own or with another diagnostic test, are an effective screening tool for any medical condition, including the early detection of breast cancer or other diseases and health conditions. Mammography, which involves taking X-rays of the breasts, is the most effective breast cancer screening method and the only one proven to increase the chance of survival through early detection, FDA said.

But that has not stopped some health spas, homeopathic clinics, mobile health units, and other facilities from using thermography inappropriately as a standalone tool for breast cancer screening or diagnosis. FDA said it has received reports that these types of facilities provide false information that can mislead patients into believing that thermography is an alternative or better option than mammography. Some facilities make unsupported and misleading claims such as thermography can find breast cancer years before it would be detected through other methods, or that thermography improves detection of cancer in dense breasts.

FDA said it is concerned that people will believe these misleading claims about thermography and not get mammograms to screen for breast cancer. People who choose thermography instead of mammograms may miss the chance to detect cancer at its earliest and most treatable stages, the agency noted.

Over the past eight years, FDA has issued warning letters to several facilities that have been caught making inappropriate claims about thermography. Most recently, the agency sent a warning letter to Total Thermal Imaging in La Mesa, CA on Feb. 22 for marketing and promoting thermography devices for unapproved uses.

On its website, Total Thermal Imaging advertises that clinical thermography is a simple test of physiology that relies on the sympathetic nerve control of skin blood flow and the ability of the sympathetic nervous system to respond to pain, pathology, injury, or dysfunction anywhere in the body. The clinic claims that while other diagnostics, such as ultrasound, radiography, and mammography show the body's structure or anatomy, digital infrared thermal imaging shows physiological and metabolic processes.

The agency issued similar warning letters to five other facilities between January 2011 and April 2017.

SyncThink Scores FDA Breakthrough Device Designation for Concussion Tech

FDA has granted a breakthrough device designation to SyncThink's Eye-Sync technology. The objective eye-tracking platform is currently used to assist clinicians in evaluating visual impairments, monitor recovery and support the rehabilitation of ocular-motor and ocular-vestibular deficits, and in the optimization of brain performance.

The breakthrough device designation recognizes the technology's potential to provide objective measurements to aid in the assessment of concussion.

FDA's breakthrough devices program is intended for products that provide more effective treatment or diagnosis of conditions and the program was created as an effort to provide patients and healthcare providers with timely access to medical devices. The program works to shorten the timeframe within which medical devices are approved.

“With millions of concussions occurring each year the need for a rapid, mobile and, most importantly, objective metric for impairment and recovery is clear and we are thrilled that the FDA is recognizing the importance of this work,” said Laura Yecies, CEO of SyncThink

FDA initially cleared the Eye-Sync platform in March 2016 for recording, viewing, and analyzing eye movements to help clinicians identify visual tracking impairment. The platform is a modified virtual reality headset with infrared cameras that connect wirelessly to a tablet where results are viewable to the clinician within 60 seconds. The platform includes Eye-Sync Smooth Pursuit, Eye-Sync VOR, and Eye-Synch Saccade based assessments.

A Look at the Competitive Landscape of Diabetes Devices

Diabetes represents a huge market opportunity for medical device companies, but that also makes for a tough competitive landscape. Here we have reviewed the key players and what 2019 could have in store for them, based on recent news and earnings calls.

Abbott Is on a Tear 

Abbott's latest milestone in the diabetes space is a non-exclusive partnership that will integrate insulin dose data from Novo Nordisk's pre-filled and durable connected pens directly into the digital health tools compatible with the FreeStyle Libre system.

The companies said that integrating the two products will enable diabetes patients, caregivers, and clinicians to view glucose and insulin data together to help them make more informed treatment decisions and to have a more meaningful and productive conversation about health outcomes.

Abbott CEO Miles White says the company is adding 300,000 new Freestyle Libre patients per quarter and growing. More than 1.3 million diabetes patients are currently using the device for continuous glucose monitoring, he said during the company's earnings call in late January.

Abbott recently launched the Libre 2 system in Europe and White said the new iteration of the device should make it to the U.S. market shortly.

"And I’d say, a significant quantum of capacity will come online in the second half of this year. And from my perspective, that allows us to open the floodgate much wider," White said. "At this point, we’re having a tremendous amount of success with Libre without putting much push behind it. And at that point, we’re going to have an ability to turn on a lot of push."

He noted that there is a steady cadence of capacity additions to the platform after that.

"I think this is a very big, long-term, sustainable growth product for the company," White said. "I don’t have any other way to say it. This is a hell of a good product."

DexCom Will Double Its G6 Production Capacity This Year

The key word in Abbott's news about the Novo Nordisk agreement is "non-exclusive" meaning that companies like DexCom, which also has a relationship with Norvo, shouldn't have to worry.

"We announced our relationship with Norvo back in October, and I can tell you we've been working with Novo for far longer than that," DexCom CFO Quentin Blackford said in response to an analyst's question during the company's earnings call last week." "We continue to push forward to develop software tools, robust software tools to integrate our CGM together with their intelligent insulin pen technologies that will be coming to market. So, I don't think that announcement earlier this week has any impact."

CEO Kevin Sayer also talked about the competitive landscape of the space during the call, as transcribed by Seeking Alpha.

"With respect to competition, we take competition seriously all the time," he said. "While it hasn't slowed on our growth trajectory, I would say if anything our vision and our focus on the competitive environment is much greater than it has been before and as we design our products and our future pipeline, we want to take advantage of those things that we do well to continue to forward competition."

Blackford also pointed out that it's still very early in the continuous glucose monitoring (CGM) game. 

"We're so early in the opportunity of converting folks from traditional finger sticks to CGM that the opportunity in the way of volume growth from the adoption of CGM technology is so significant that while there is going to be revenue per patient headwinds over time, I think the volume opportunities significantly outweighs any of those headwinds."

Sayer said DexCom has big ambitions for 2019.

"In light of our meaningful uptick and demand, we have set the aggressive internal goal to double our G6 production capacity by year-end," he said. "We need to expand our footprint dedicated to manufacturing within the Arizona facility, both to meet our G6 goals and in anticipation of a late 2020 launch of G7."

In addition to scaling its manufacturing capacity, Sayer said DexCom has had to rethink how it builds its customer-facing infrastructure to better serve its rapidly growing patient base in order to build a sustainable infrastructure for the future.

We have therefore expanded and reorganized our customer support efforts, which includes an increase of resources on our new Philippines location, as well as outsourcing other functions through third parties," he said. "This move will provide the ability to serve our customers with the same high level of quality that they have become accustomed to and grow in a much more efficient manner."

Sayer said the expansion will result in organizational changes, including a workforce reduction its San Diego and Arizona facilities, despite an expected overall increase in employee numbers in these locations this year.

Medtronic's Is Taking Diabetes Personally

Medtronic continues to roll out its 670G insulin pump system throughout the world and in the coming fiscal year, the company expects to launch its hybrid closed-loop system with Bluetooth, which Medtronic has dubbed the MiniMed 780G.

The 780G will feature next-generation algorithms, designed to improve time in range to over 80% by automating insulin delivery following a snack or a meal. In addition, the system will reduce the burden of carb counting and enable remote monitoring and remote software downloads.

The company also plans to submit an application for a non-injunctive designation for the Guardian Sensor 3 CGM in the next few months.

FDA recently granted breakthrough device designation to Medtronic's personalized closed-loop system that will feature real-time personalized algorithms designed to automate insulin delivery on a personalized basis that continuously adapts to the user. The system will also provide insights and predictive diagnostics, unique to the individual, all of which will dramatically simplify diabetes management for the patient, Medtronic noted.

The company also said it is advancing its CGM sensor pipeline by reducing the need for calibration and making the sensors smaller and longer lasting, all while using cognitive computing to enhance personalized insights.

Tandem Is Blazing New Trails

FDA recently approved San Diego, CA-based Tandem Diabtes Care's t:slim X2 insulin pump. The approval created a new device category called alternate controller enabled infusion pumps (ACE Pumps). Along with this authorization, the FDA is establishing criteria, called special controls, which outline requirements for assuring the accuracy, reliability, cybersecurity and clinical relevance of ACE pumps, as well as describe the type of studies and data required to demonstrate acceptable pump performance.

The approved indication for the t:slim X2 pump states that the pump is able to reliably and securely communicate with compatible, digitally connected devices, including automated insulin dosing software, to receive, execute, and confirm commands from these devices.

U.S. Firm Shale Support Exports Frac Sand to Argentina

American proppant solutions firm Shale Support recently joined forces with transportation company Fracht Group in a strategic partnership to export frac sand from the U.S. to the Vaca Muerta shale play in Argentina, the firms announced in a press release Thursday. 

The partnership will supply Delta Pearl frac sand produced in the U.S. Gulf Coast to the South American operation. A shipment of sand left the port of New Orleans on February 18 and is slated to arrive at the port of Bahia Blanca on March 10. 

SMART Biomass Storage and Feeding System

SMART containers are a robust and cost-effective biomass storage and feeding system built from repurposed sea containers. The push-pull wedge-floor system in these bins meters material output evenly and consistently. The bins provide a fast, flexible, convenient, and economical solution for storage with a consistent feed.

Scoular Names New Director of Occupational Safety

American agribusiness The Scoular Company recently named Derek Farmer, formerly the health, safety and security manager at engineering company Arconic, as its new Director of Occupational Safety, the firm announced in a recent press release.

Slated to join Scoular on March 4, Farmer will be based out of the company’s Overland Park, KS office and report to Vice President Glen Hofbauer. 

Beauty Products Maker Avon Sells Plant in China for $47M

Beauty products manufacturer and marketer Avon Products Inc. announced last Friday that the company closed the sale of its production plant in Guangzhou, China to a subsidiary of South Korean firm LG Household & Health Care Ltd.

TheFaceShop Ltd. acquired Avon’s shares in the facility for $47 million. The new owner of the plant will continue to produce Avon products for sale in China and other markets under a manufacturing and supply agreement. Workers employed by Avon at the Guangzhou site will join TheFaceShop. 

Richardson Buys Cooking Oil Brand Wesson, Production Site

Canadian agribusiness and food processor Richardson International closed its acquisition of the American cooking oil brand Wesson after completing regulatory approvals and other closing requirements, the company announced Monday. 

Abbott Labs Investing $62M in Upgrades at Ohio Plant

Health care products maker Abbott Laboratories is planning to invest $62 million in its Columbus, OH infant formula and adult nutrition products manufacturing plant to build a new structure and acquire new machinery and equipment, according to documents filed this month with the City of Columbus. 

Solvay to Add Capacity for Soda Ash, Sodium Bicarbonate

Specialty chemicals and advanced materials producer Solvay is launching a series of “efficiency programs” to increase production at its soda ash and sodium bicarbonate production facilities, the firm announced in a press release Monday.

Over the next two years, the Belgian company will expand capacities for soda ash by some 500 kt and sodium bicarbonate by 100 kt. The move is in response to “a tight market” and a rise in demand.