Sen. Warner enlists healthcare industry help on cybersecurity


[Image courtesy of Blogtrepreneur on Flickr, per Creative Commons 2.0 license]

U.S. Senator Mark Warner (D-Va.) is wrote a letter to several healthcare organizations yesterday, asking their help in improving cybersecurity in the industry.

A member of the Senate Finance Committee and chair of the Senate cybersecurity caucus, Warner pointed to apparent gaps in oversight, expressed concern about the impact of cyberattacks on the health care sector, and said he wants to help develop strategies that strengthen information security.

Ransomeware and other cyberattacks have stunned the healthcare industry. The 2017 WannaCry attack affected hospitals in the U.S. and U.K., including medical devices made by Bayer, Siemens and others, according to the Health Information Trust Alliance. A 2017 report by internet security software company Trend Micro found that more than 100,000 medical devices and systems were exposed directly to the public internet. The U.S. Department of Homeland Security issued an alert in 2018 indicating that several GE Healthcare imaging devices were vulnerable to cyberattack.

Healthcare hacking incidents accounted for 44% of all tracked data breaches in 2018,  the most of any type of breach, according to a report published in HIPAA Journal.  FDA published an updated draft of its cybersecurity premarket guidance for medical device makers in October 2018.

Warner’s office sent the letters to medtech trade group AdvaMed, the Healthcare Information and Management Systems Society, the American Hospital Association, and several other organizations.

“I would like to work with you and other industry stakeholders to develop a short and long term strategy for reducing cybersecurity vulnerabilities in the health care sector,” Warner said in the letter. “It is my hope that with thoughtful and carefully considered feedback we can develop a national strategy that improves the safety, resilience, and security of our health care industry.”





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Axonics Modulation touts results of sacral neuromodulation study

Axonics Modulation TechnologiesAxonics Modulation Technologies (NSDQ:AXNX) announced positive top-line results from a pivotal study of its novel implantable sacral neuromodulation (SNM) devices for the treatment of urinary and bowel dysfunction.

The clinical study demonstrated that patients implanted with the Axonics r-SNM system experienced clinically meaningful and statistically significant improvements in urinary urgency incontinence (UUI) symptoms and quality of life, according to the Irvine, Calif.-based company. The study also met all secondary endpoints, and no serious device-related adverse events were reported.

Get the full story on our sister site, Medical Design & Outsourcing.

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Phillips-Medisize is offering connected health data services: Here’s how

One of the world’s largest medical device contract manufacturers, Phillips-Medisize is making a business play to provide the technological back end for connected drug delivery devices.

Phillips-Medisize Connected Health Platform

[Image courtesy of Phillips-Medisize]

Phillips-Medisize used to be all about the housings, assembly and packaging that went into finished drug-delivery devices. Electronics was something that other contract manufacturers did.

Within a few years, the situation has dramatically changed.

Phillips-Medisize — a Hudson, Wis.–based contract manufacturer with thousands of workers at dozens of facilities around the world — has become not only focused on connected drug-delivery devices but also on the data systems behind them. Company officials say they already have more than 25 potential customers in the pipeline for their third-generation Connected Health Platform, an FDA-registered medical device data system that rolled out in October 2018.

How Phillips-Medisize got into the data systems business is but one example of how medtech contract manufacturers are adapting to an age in which every product seems to have some kind of digital or connected feature.

Get the full story on our sister site Medical Design & Outsourcing. 

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Apollo Endosurgery touts results of stomach-stapling study


Apollo Endosurgery’s OverStitch device

Apollo Endosurgery (NSDQ:APEN) has reported key data from 1,000 patients who underwent endoscopic gastroplasty using the company’s OverStitch device.

Published in the journal Gastrointestinal Endoscopy, the data include a mean total weight loss of 14.8%±8.5% at 18 months. Three months following surgery, the impact on obesity-related comorbidities included the complete remission of:

    • 13 of 17 cases of type 2 diabetes.
    • All 28 cases of hypertension.
    • 18 of 32 cases of dyslipidemia.

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Here’s how a new Abbott device is making a difference among neonatal infants

Abbott Piccolo premie

[Image courtesy of Abbott]

A recent CBS News report provided a real-life example of how Abbott’s Piccolo occluder is making a difference among neonatal infants with a congenital heart defect called patent ductus arteriosus (PDA).

Irie and Judah Felkner are now healthy, growing 18-month-olds. But when Irie was born early at just 1 pound 13 ounces, she had a life-threatening PDA that left her mom Crissa Felkner scared that they weren’t going to bring her home.

“We saw that Irie’s heart was enlarging in size and more and more fluid was collecting in her lungs,” Dr. Aimee Armstrong, director of Cardiac Catheterization and Interventional Therapies at Nationwide Children’s Hospital, said in an Abbott news release.

Armstrong, who was Irie’s cardiologist, suggested her as a candidate for a clinical trial with the minimally invasive Piccolo device.

Dr. Evan Zahn of Cedars Sinai Smidt Heart Institute explained to CBS how the Piccolo device works: “The Piccolo device is advanced into the PDA just by gently pushing it out. That goes right into the PDA and plugs it almost immediately. We can reposition it by just drawing it back in the catheter and doing the whole thing over again until we think it’s perfect.”

Three days after the procedure, Irie Felkner was breathing on her own. She was one of the first babies treated with the device while Abbott was testing it out. FDA approved the device in January.

Abbott has more details about Felkner’s story on its website. 

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Conformis: Yale study shows customized knee implants save money

ConformisConformis (NSDQ:CFMS) is touting results of a study that found that the average overall cost of care was nearly $1,700 less among Medicare patients treated with the company’s customized individually made knee implants.

Researchers at the Yale School of Medicine and Baker Tilly Virchow Krause conducted the study, which reviewed episode expenditures for all of 2015 among 4,434 Medicare beneficiaries, 739 receiving Conformis customized implants and 3,695 receiving standard off-the-shelf implants.

Results, presented at a recent Knee Society Meeting, found the average overall episode of care was $18,585 for patients with Conformis implants, versus $20,280 for patients with off-the-shelf implants.

Dr. Mary O’Connor, director of the Center for Musculoskeletal Care at Yale School of Medicine and the study’s lead researcher, described the study as the first long-term analysis of the economic impact of Conformis implants among Medicare-funded patients.

“The largest reductions in episode spending were associated with Conformis CIM patients who had overall fewer costs associated with the procedure and hospital stay as well as their post-acute care needs,” O’Connor said in a news release. (Note: O’Connor’s research institute receives support from Conformis, but O’Connor receives no personal compensation from the company.)


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Intuitive Surgical wins FDA clearance for robotic-assisted lung biopsy system

Intuitive Surgical robotic assisted surgery Ion system lung cancer biopsy

Intuitive Surgical’s Ion system includes an articulating robotic catheter able to navigate through small and tortuous airways during lung biopsy procedures. [Image courtesy of Intuitive Surgical]

Intuitive Surgical (NSDQ:ISRG) said today that FDA has cleared its Ion system — a robotic-assisted, catheter-based platform meant to enable minimally invasive biopsy deep within the lung.

Sunnyvale, Calif.–based Intuitive plans to start selling the Ion system in the U.S. in a measured fashion; it’ll start shipping to customers in coming months.

The Ion system includes an articulating robotic catheter with an outer diameter of only 3.5 mm that is able to move 180 degrees in all directions, allowing a physician to navigate the catheter through small and tortuous airways to reach nodules. The system’s Flexision Biopsy Needle is also able to pass through tight bends as it travels through the Ion’s catheter to collect peripheral lung tissue. Other biopsy tools are also able to fit inside the catheter’s 2 mm working channel, including biopsy forceps or cytology brushes.

Fiber optic shape sensor technology in the Ion system provides the catheter’s precise location and shape information throughout the procedure. Intuitive officials say they designed the Ion system to easily integrate into existing lung nodule biopsy workflows.

“The Ion system represents Intuitive’s continued commitment to innovating for minimally invasive care, and extends our focus beyond surgery,” said Intuitive Surgical CEO Gary Guthart. “At Intuitive, we innovate for need, and lung cancer is clearly a global health challenge that requires new modalities of care.”

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Medtronic risk prediction tool could help prevent opioid deaths: Here’s how

Medtronic logo updatedMedtronic officials continue to hone their arguments for how the company’s capnography and oximetry systems could reduce potentially deadly opioid-induced respiratory compromise.

The medical device giant on Feb. 17 announced preliminary results of its Prodigy study, in which the company’s Microstream and Nellcor monitoring technology provided continuous capnography and oximetry for 1,496 patients across 16 sites in the U.S., Europe and Asia.

The study resulted in what Medtronic says is an easy-to-use risk prediction tool. Called the Prodigy score, it helps identify patients on the hospital general care floor who are taking opioid medications and are at high risk of developing a respiratory compromise.

The score takes into account variables including age, gender, sleep disorders, chronic heart failure and opioid naïvety. During the Prodigy study, it identified more than three-fourths of patients with confirmed respiratory depression.

Overall, opioid-induced respiratory depression occurred in nearly half of the patients in the study.

“Clinical evidence shows that acute and unexpected respiratory compromise on the general care floor is increasingly common. Until now, we have not been successful in predicting which patients are at high risk when recovering on the general care floor,” said Dr. Ashish Khanna, the primary study investigator and an associate professor of anesthesiology and intensivist at the Wake Forest School of Medicine.

“These data validate an easy-to-use [opioid-induced respiratory depression] risk prediction tool to identify patients at the highest risk and guide early intervention using continuous capnography-based monitoring. Early identification and intervention in these high-risk patients has the potential to improve patient safety and decrease the economic and clinical burden of unplanned ICU admissions,” Khanna said in a news release.

Opioid-induced respiratory depression is a “common, costly and deadly but preventable condition,” and Medtronic through the Prodigy study is committed to help, said Vafa Jamali, SVP and president of the Medtronic’s respiratory, gastrointestinal and informatics business.

“We are encouraged by the data demonstrating the use of the Prodigy OIRD risk prediction tool,” Jamali said. “It can help clinicians prioritize resources by identifying those patients at highest risk on the general care floor who should be continuously monitored with capnography and pulse oximetry.”



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Phillips-Medisize is expanding in Wisconsin

Phillips-Medisize Hudson Wisconsin

Work is underway on Phiillips-Medisize’s new 230,000-square-foot manufacturing facility in Hudson, Wis. [Image courtesy of Phillips-Medisize]

Phillips-Medisize, a Molex company, has broken ground on a new manufacturing facility in Hudson, Wis., on the eastern end of the Minneapolis-St. Paul metro area.

The 34-acre location at the St. Croix Meadows development will support at least 230,000 square feet of manufacturing space for FDA-regulated medical device products, Phillips-Medisize announced yesterday. After construction is complete in mid-2020, the plant will employ more than 250 employees in fields ranging from advanced manufacturing to engineering.

Get the full story on our sister site Medical Design & Outsourcing.

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ReWalk Robotics files for exoskeleton suit clearance


ReWalk Robotics’ exo-suit designed for stroke rehabilitation.

ReWalk Robotics (NSDQ:RWLK) said it has applied to FDA for 510(k) clearance of its ReStore exoskeleton suit for gait training during stroke rehabilitation.

The Yokneam, Israel-based company designed its exo-suit to provide coordinated plantarflexion and dorsiflexion assistance to a patient’s foot and ankle. It recently won insurer reimbursement from Cigna and completed a clinical trial involving 44 patients at five rehabilitation centers in the U.S.

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