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Articles from 2019 In March


Magnetic System Aims to Make Bariatric Surgery Less Invasive

Magnetic System Aims to Make Bariatric Surgery Less Invasive
Image courtesy of Levita Magnetics

A recent study concluded that a "first-of-its-kind" magnetic surgical system allows a safe, reproducible, incision-less technique for port-less intraabdominal mobilization. The Magnetic Surgical System, developed by Levita Magnetics, is so unlike current technologies that FDA had to create a whole new category for it when approving it for use, according to Alberto Rodriguez-Navarro, MD, CEO and founder of Levita Magnetics, in an interview with MD+DI.

The system consists of an external magnet placed on the skin that controls a shaftless detachable grasper. It enables surgeons to move instruments without the constraints of a fixed-position pivot point, while facilitating access and visualization of the surgical site.

In conventional laparoscopic procedures, shafted surgical instruments are introduced by fixed-position trocars inserted through incisions in the abdomen. Because they have a fixed pivot point, using these instruments can affect the surgeon’s vision by cluttering the operative field—they can also cause instrument collisions and restrict movement. Further, the use of trocars is also associated with risks relating to major bowel and vessel injury, incisional pain, bleeding, scarring, hernias, and infection.

With magnetic surgery, there are no limitations in moving the instruments. “That’s the beauty of magnetic surgery—that you are not restricted by the entry point,” Rodriguez-Navarro said. “That is a big advantage for the surgeon in terms of creating the right angle that you need for moving the tissues that you’re seeing while you are doing the surgery,” he continued.

“Using magnetic tools has enabled surgeons to reduce the number of incisions, and it enables surgeons to do movements that you cannot do with conventional instruments,” he said. This means the surgeon will be able to see better, which leads to a more efficient surgery, with less accidental damage to surrounding tissue, organs, or nerves.

“Multiple procedures are [currently] done with five incisions,” said Rodriguez-Navarro. Using magnetic surgery, he said “we are able to lower the number of incisions to four, three, or even just one incision,” adding that, in the end, that translates to less damage to organs and tissue during procedures. “We believe that also should impact in the overall recovery of the patients and their recovery should be faster.”

This is borne out in the study, which also evaluated the length of stay after bariatric surgery. It showed that when magnetic surgery was used, people spent less time recovering in the hospital. The data is preliminary but Rodriguez-Navarro sees a rationale behind it. “Because if you reduce pain, and also reduce damage to the organs, you have less inflammation, and that translates to feeling better after surgery,” he said.

To date, patients have undergone magnetic surgery at clinical centers including the Cleveland Clinic, UT Southwestern Medical Center, Stanford University, and Duke University, among others. Although the company is just beginning its rollout of the system, Rodriguez-Navarro says the feedback from clinicians has been outstanding.

“The system is now indicated for gall bladder and obesity procedures, and we are working actively on a prostate indication.” Other uses will likely follow, he said.

FDA Classifies Anthrax Tests as Class II with Controls

FDA Classifies Anthrax Tests as Class II with Controls
Bacillus bacteria detection devices were previously unclassified, known as “preamendment devices,” since they were in commercial distribution prior to May 28, 1976, when the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act were signed into law. FDA has now issued a final rule to clarify the regulatory pathway for this type of device.

FDA issued a final rule classifying in vitro diagnostic devices for the detection of Bacillus anthracis (the bacteria that causes anthrax) into class II (moderate-risk) with special controls, which means the agency will continue to require a 510(k) premarket notification for these devices.

“Anthrax is a bioterrorism threat because the spores are resistant to destruction and can be spread by release in the air. Exposure to anthrax can and has caused serious injury or death," said FDA Commissioner Scott Gottlieb, MD, who is expected to resign soon.

Gottlieb said that access to safe and effective devices that can detect Bacillus anthracis in the body is an important part of the public health response to an anthrax-related attack. He said the rule issued on Friday finalizes the agency's effort to provide a clear and predictable pathway for these specific test developers.

"This final rule helps manufacturers who market these products understand the requirements, including testing criteria and how to address potential safety risks for lab workers using the devices, to ensure availability of safe and effective diagnostic tests in the face of bioterrorism threats," Gottlieb said.

Because of the risk of exposure to anthrax, especially the risks that the quality control organisms and specimens associated with these devices could pose to lab workers, FDA said it also is restricting distribution of these products to laboratories that follow public health guidelines to address appropriate biosafety conditions, interpretation of test results, and coordination of findings with public health authorities, to reduce the risks associated with handling these specimens.

Bacillus bacteria detection devices were previously unclassified, known as “preamendment devices,” since they were in commercial distribution prior to May 28, 1976, when the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act were signed into law. Because of this, prior to this final rule, there had not been a final agency determination about the testing criteria required, or the regulatory pathway to use for this type of device.

The final rule will become effective 30 days after its publication in the Federal Register.

AI Program Can Predict Premature Death

AI Program Can Predict Premature Death
Could AI predict premature death? A recent study suggests it's possible.

As MD+DI has previously reported, artificial intelligence is playing an increasingly significant role in medical devices. Now, a new study from the United Kingdom suggests that AI could be used to predict premature death. The findings could have major implications for preventative healthcare, according to researchers at the University of Nottingham.

The team of healthcare data scientists and doctors have developed and tested a system of computer-based machine learning algorithms to predict the risk of early death due to chronic disease in a large middle-aged population, the university reported.

The researchers said the AI system was very accurate in its predictions and performed better than the current standard approach to prediction developed by human experts. The study is published on March 27, 2019, by PLOS ONE. 

The researchers used health data from more than half a million people between the ages of 40 and 69 recruited to the UK Biobank between 2006 and 2010 and followed until 2016.

"Preventative healthcare is a growing priority in the fight against serious diseases, so we have been working for a number of years to improve the accuracy of computerized health risk assessment in the general population," said Stephen Weng, PhD, an assistant professor of epidemiology and data science at the University of Nottingham. "Most applications focus on a single disease area but predicting death due to several different disease outcomes is highly complex, especially given environmental and individual factors that may affect them."

Weng, the lead author of the study, explained that he and his colleagues have taken a major step forward in this field by developing a unique and holistic approach to predicting a person's risk of premature death. The method uses computers to build new risk prediction models that take into account a wide range of demographic, biometric, clinical, and lifestyle factors for each individual. Even the person's daily consumption of fruit, vegetables, and meat is assessed, he said.

“We mapped the resulting predictions to mortality data from the cohort, using Office of National Statistics death records, the UK cancer registry and ‘hospital episodes’ statistics," Weng said. "We found machine-learned algorithms were significantly more accurate in predicting death than the standard prediction models developed by a human expert.”

The team used AI machine learning models known as "random forest" and "deep learning," which were pitched against the traditionally-used "Cox regression" prediction model based on age and gender (found to be the least accurate at predicting mortality), and also a multivariate Cox model, which worked better but tended to over-predict risk.

“We believe that by clearly reporting these methods in a transparent way, this could help with scientific verification and future development of this exciting field for healthcare,” said Joe Kai, a clinical professor at the university and another author on the study.

The recent study builds on previous work by the same team which showed that four different AI algorithms were significantly better at predicting cardiovascular disease than an established algorithm used in current cardiology guidelines. That study was published in PLUS ONE on April 4, 2017.

Illumina and BGI Clash over Patent in German Court

Pixabay Illumina and BGI Clash over Patent in German Court

Illumina and BGI are due for a showdown in a German Court in the near future. San Diego-based Illumina said it has filed a patent infringement suit against one of BGI Group’s subsidiaries Latvia MGI Tech SIA.

The lawsuit alleges that Shenzhen, China-based BGI’s sequencing products, including the BGISeq-500, MGISeq-2000, and related chemistry reagents, infringe EP 1 530 578 B1. This patent covers Illumina’s sequencing-by-synthesis chemistry.

“Illumina will not tolerate the unauthorized, infringing use of its patented technology. Illumina filed this suit to defend the substantial investments we have made in our industry leading sequencing technology, as validated in our global intellectual property portfolio,” Charles Dadswell, Senior vice president and general counsel for Illumina, said in a release. “We will continue to monitor the field and file patent suits where appropriate when our patents are infringed.

The ‘578 patent is one of numerous patents that protect Illumina’s sequencing technology. Its validity has been affirmed by the European Patent Office in opposition proceedings.

Similarly, the U.S. counterpart to the ‘578 patent was upheld by the U.S. Patent Trial and Appeal Board over challenges filed by BGI and its subsidiary, Complete Genomics, Inc., in Inter PartesReview Nos. IPR2017-02172 and IPR2017-02174.

The lawsuit comes on the heels of Illumina making a proposal to acquire PacificBio for $1.2 billion. PacBio fills an important gap in Illumina’s offerings.

For years Illumina has prided itself on using short-read technology to sequence DNA. This means it takes lots of small fragments of DNA and puts them together. However, PacBio is the opposite and has long-read sequencing capabilities, which means it can decode longer pieces of DNA with high accuracy. The deal is set to close in mid-2019.

Outgoing FDA Commissioner Plans to Make All Device Incidents Public

Pixabay Outgoing FDA Commissioner Plans to Make All Device Incidents Public

There’s a new chapter in the ongoing saga of the medical device adverse event reports. In the latest entry, outgoing FDA Commissioner Scott Gottlieb tweeted on Wednesday that all of the adverse event reports would be made open to the public.

Here's Gottlieb's tweet:

To recap, the agency came under fire earlier this month when Kaiser Health News reported that at least 1.1 million incidents had been reported through the alternative summary reporting (ASR) repository instead of being disclosed through the public database known as MAUDE.

In an interview with MD+DI earlier this month, an FDA spokesperson said the agency issued a guidance document about the program in October 2000 that is still publicly available and solicited public comments on the document required by law.

FDA modified the conditions of ASR exemptions in 2017 to include the submission of Form 3500A, which summarizes the reports submitted for that quarter and is available in the MAUDE database.

The agency noted that each MDR summary report is posted on MAUDE and clearly identifies the number of adverse events associated with the summary report, so patients or others in the public will have increased visibility regarding the number of reported adverse events that may be related to the same issue or device.

The agency said the majority of the exemptions were revoked following a review of the program, and that generally only low-risk products are eligible for voluntary malfunction summary reporting.

Gottlieb’s pledge to make the adverse events public comes shortly before his exit from FDA next month. He is stepping down nearly two years after he was appointed to the top position of the regulatory agency.

MD+DI reported that Norman Sharpless, director of the National Cancer Institute, will become “acting” commissioner until a permanent replacement is found.

Could Biolinq’s Patch Change the Game for CGMs?

Pixabay Could Biolinq’s Patch Change the Game for CGMs?

Biolinq has a plan to redefine continuous glucose monitoring (CGM) and investors are supporting it. The San Diego-based just announced it raised an additional $4.75 million in a series A round to help it get its CGM patch through clinical trials. The latest tranche was led by the JDRF T1D Fund, Aphelion Capital and LifeSci Venture Partners.

Previously, Biolinq had closed on $10 million in the round – bringing the total financing amount to nearly $15 million. The funding round was no easy task, said Jared Tangney, Biolinq’s CEO.

“There have been a lot of investors that have been burned with diabetes technology that hasn’t panned out,” Tangney told MD+DI. “It was a bit of a challenge overcoming that. But once we got to the point where we had some data showing that the sensors worked; our approach was very viable; and that we had started to build a Rockstar team around this - it started to give investors comfort.”

The company's first product is designed to allow patients with diabetes to monitor their blood glucose levels without the pain and hassle of traditional CGM systems, which often involve frequent needle pricks.

“Our approach to CGM is definitely very different [from] the existing sensors on the market, like Dexcom, Medtronic, or Abbott, Tangney said. “They’re all good technologies, but they’re all quite invasive. They have a fairly large needle that introduces a sensor under the skin. We’re using a microarray and the microarray has very small protrusions on it. When applied to the skin they only go a fraction of a millimeter deep.”

He added, “what that allows us to do is measure interstitial fluid. We actually sense [glucose levels] in that fluid. Because we’re not going deep enough to strike any blood vessels or nerves to the user, there is really no perception of pain at all.”

The success of Dexcom and Abbott Laboratories receiving FDA approval of the Freestyle Libre Flash opened the doors for Biolinq’s support.

“I think what (the Freestyle Libre Flash’s approval) in combination with Dexcom’s growth over the last five years showed, is that this is a hot space and growing market,” Tangney said. “There’s a real need for it.”

CGM On The Move

The CGM segment of the diabetes market has been moving at a fast pace because of several product approvals.

Senseonics dominated headlines last year when its Eversense CGM received FDA approval. A few months after winning a nod for a 90-day-version of Eversense, the Germantown, MD-based company obtained approval for the device to be inserted by qualified nurse practitioners and physician assistants.

In July of last year, FDA signed off on a 14-day-version of Abbott’s Freestyle Libre Flash. The previous version was for 10 days.

Dexcom managed to shake up the diabetes space after FDA granted it the right to market the Dexcom G6 CGM System, a device that is interoperable with other automated insulin dosing systems. FDA said this is the first device that has been given approval to work with other compatible technologies. The agency also said its decision classifies Dexcom’s CGM as a less stringent medical device and enables a speedier review for similar future systems.

But it wasn’t all good news in the world of glucose sensing technologies. In November of 2018, Novartis and Verily (Google’s former life sciences division) announced putting the brakes on a plan for its smart lens to detect glucose levels. The two firms said they would continue to focus on the smart accommodating contact lens and smart intraocular lens projects.

Voice-Enabled Cellular Blood Pressure–Monitoring System Encourages Patients to Make Healthy Decisions

Voice-Enabled Cellular Blood Pressure–Monitoring System Encourages Patients to Make Healthy Decisions
Image courtesy of Livongo

“Despite all the advances in digital health and how technology is applied in healthcare, the daily life for a person with a chronic condition hasn’t improved much at all in the past few decades,” said Livongo Chief Product Officer Amar Kendale in an interview with MD+DI. “That is because the U.S. healthcare system has responded to the chronic-condition epidemic by giving health consumers more in terms of data, devices, and medications, but none of that is really connected and applied in how a person actually lives.” He said that more is not always better, and may just create “noise” for the patients.

To silence this noise, Livongo has recently launched what it calls Applied Health Signals, which is a new category of technologies and capabilities that include data science, behavior change, and clinical impact that work together to benefit the company’s members. Membership is obtained through a patient’s employer or healthcare plan.

One of the company’s newest technologies is its voice-enabled blood pressure–monitoring system, which Livongo is working on getting into the hands of its members, said Kendale.

“When a member sits down to check their blood pressure, they hit the power button to begin checking. After that process is complete, their reading is automatically transferred from the device to the Livongo database. We call that process Cuff to Cloud,” said Kendale.

Once the reading reaches the cloud, it is processed through Livongo’s AI+AI, (which stands for aggregate, interpret, apply, and iterate) engine, where the company uses advanced data science to offer the member a personalized “health nudge.” “Then, we use voice technology, delivered through our partnership with Amazon Lex, to deliver [to] the member their blood pressure reading and a personalized health nudge in real time,” Kendale continued, adding that health nudges are short, encouraging, actionable messages that help members take their next healthy action. “They give members positive reinforcement on their checking patterns, provide insights about patterns we observe, and refer members to product features, among other use cases.”

“By enabling them with voice technology, we can allow them to sit in a comfortable place, check their blood pressure, and automatically hear their blood pressure reading with health tips, without having to do anything else,” said Kendale.

Recent research points to encouraging results for users of the technology. In the study, people with both diabetes and uncontrolled high blood pressure who used the Livongo for hypertension solution saw significant declines in their blood pressure within six weeks.

All study participants received a blood pressure monitor and cuff that connected wirelessly with Livongo’s smartphone app. When participants measured their blood pressure with their smartphones nearby (which they did an average of four times a week), the readings were automatically transmitted to Livongo’s computer servers.

After each reading, participants could open the app to review the results and get tips on managing their blood pressure. The app also enabled them to compare their blood pressure readings over time, schedule a call with a health coach, and share their results with family members, friends, or healthcare providers.

At six weeks, study participants’ systolic blood pressure number declined by an average of 5.4 mm Hg, and diastolic pressure readings declined by 3.5 mm Hg on average compared with their levels at study entry.

The study did not include a control group that received usual care for high blood pressure, however the company has plans to conduct a trial in which patients are randomly assigned to either use the app or receive usual care.

Supplier Stories for the Week of March 24

Bally Ribbon Mills (BRM) offers a line of biomedical tapes and webbing suitable for use in cardiovascular, orthopedic, and dental prosthetic applications. BRM’s woven seamless tubular materials for stent and bifurcated graft designs offer solutions for aortic repair and endo-luminal devices, the company reported in a news release. Other BRM cardiovascular textiles could be suitable for trans aortic valve replacement and aseptal defect repair. The biomedical line features woven tapes and webbing in flat fabrics or straight or bifurcated tubular structures. Monofilament materials used in blood filtration, aspirating devices, and bone marrow transplants are also available. Braided composite substrates are available for materials used in the manufacture of prosthetic devices.BRM manufactures medical items in a certified cleanroom to ensure cleanliness and quality. It maintains ISO 13485:2016 certification for the design and manufacture of medical devices. BRM medical textiles engineers, prototype weavers, and braiders work on a confidential basis to protect the intellectual property of customers, the company reported.[Image courtesy of BALLY RIBBON MILLS]Editor's Note: If you have news you’d like to submit for potential inclusion in future weekly roundups, please send a press release and any related images to daphne.allen@ubm.com with the subject line “Supplier Stories.”

MTD Micro Molding Honors Late President

MTD Micro Molding Honors Late President
Dennis Tully with the MTD Micro Molding team at the Pawtucket Red Sox game in 2018, on the field. Tully can be seen wearing a Red Sox hat at middle right. Image courtesy of MTD Micro Molding.

The staff of MTD Micro Molding, a specialist in ultra-precision medical micro molding, is mourning the loss of President Dennis Tully, who passed away unexpectedly in February.

Tully had grown Miniature Tool & Die from his father’s electronics components mold making business into MTD Micro Molding, a globally recognized and respected producer of ultra-miniature medical components. Along the way, Tully doubled the company’s workforce, invested 10% of its annual revenue in innovation, and built an award-winning medical plastics processing business.

Tully will long be remembered for empowering and inspiring employees, encouraging teamwork, and building friendships. Several MTD Micro Molding employees shared their words of remembrance with MD+DI, demonstrating that one of Tully’s greatest accomplishments was bringing people together to address the medtech industry’s challenges.

“Dennis had a gift of creating a work place that felt like home,” Patrick Haney, R&D engineer, recalled. “His ability to bring people together to work as a team is a characteristic that is all too often forgotten and not at all mastered by most people. He was truly an influential force and an exceptional role model, and I was honored to have known and worked for him.”

“Dennis was a lover of life and truly believed in the good of people,” Lindsay Mann, MTD’s sales and marketing director, told MD+DI. “He was a fearless leader—willing to make mistakes, try new things, take risks—all for the betterment of his company and his employees. Dennis taught me that there is a solution to every problem. In fact, he built an extremely successful business around that concept. I am so proud of the business that Dennis has created and to be a member of the MTD team, which thanks to him, has become family. He will be missed forever.”

Tully was “intelligent, compassionate, generous, and considerate of his employees,” said Kim Goodwin, director of quality. “Nurturing and analytic at the same time.”

Tully was continually driving MTD forward. “For years he had a vision for the future of MTD that only he could fully understand and bring to fruition,” recounted Sandy Livermore, office coordinator. “As a key team player he worked side by side with us methodically building, growing, and strengthening the bonds of what has become the MTD of today.”

Above: Dennis Tully (shown curling at right) at MTD Micro Molding’s annual curling tournament in Petersham, MA. Image courtesy of MTD Micro Molding.

Added Carl Lemieux, mold maker: “I heard him on multiple occasions thank us for allowing him to be able to live the lifestyle he lived. He was grateful for us, yet he provided the environment for us to succeed.”

The MTD team is committed to continuing Tully’s approach. Said PJ Blando, mold maker: “We need to carry on his vision and legacy here at MTD moving forward and within ourselves as individuals.”

MTD remains privately owned and will continue with Tully’s plans for expansion this year. “Dennis was an amazing husband, father, son, Uncle and friend,” said his wife Darlene Tully. “He was a brilliant business man who had an appreciation for every one of his employees equally. MTD was his family as well and he was proud every day of the direction in where it is going. He truly believed in his saying, ‘Be the first, Be the best, Ever forward.’ He will be forever missed.”

8 Things Manufacturers Should Know about the Fourth Industrial Revolution

A majority of today’s manufacturers have some sort of Industry 4.0 or Fourth Industrial Revolution initiative underway, according to the white paper, Fourth Industrial Revolution: Beacons of Technology and Innovation in Manufacturing from The World Economic Forum in collaboration with McKinsey & Co. The principal drivers of this revolution are connectivity, intelligence, and flexible automation, according to the report.But while “70% of industrial organizations are either piloting Fourth Industrial Revolution technology in manufacturing or deploying these technologies at scale,” according to the paper, many initiatives are stuck in “pilot purgatory.”There are risks to such stagnancy. "Laggards" won’t see the near “economy-wide gains” that pioneers do, and they will face more capital expenditures, according to the report. “The increasing importance of data and interconnectivity in manufacturing changes the dynamics of technology adoption: Waiting for cheaper and better technology does not pay off, since frontrunners are expected to capture largest benefits,” reads the report.And such risks can expand beyond a given company. “The gap between Fourth Industrial Revolution leaders and laggards has the potential to exacerbate inequality in wealth production,” the report warns. “It can, potentially, lead to significant displacement of workers in manufacturing, make critical assets vulnerable to cyberattacks, and create a dominant market position for very few artificial intelligence providers.”So what can you do to avoid being a “laggard”? In the following slides we share some key points from the white paper that could help you move your company out of “pilot purgatory.”[Figure courtesy of MCKINSEY & CO.]