EO plant shutdown leads to pediatric breathing tube shortage

Smiths Medical Bivona tracheostomy tubes are in short supply, according to the FDA. (Image from Smiths Medical)

The February shutdown of an ethylene oxide (EO) sterilization plant has produced the first temporary medical device shortage, according to the FDA.

The device in short supply is the Bivona tracheostomy tube manufactured by Smiths Medical and used by many pediatric patients. The FDA anticipates the tube will be made available again the week of April 22, according to a statement from Dr. Jeffrey Shuren, director of the agency’s Center for Devices and Radiological Health (CDRH). The state of Illinois ordered the shutdown of the Sterigenics plant in Willowbrook, Ill. due to emissions of EO, a highly carcinogenic chemical compound.

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AirXpanders touts study results

AirXpanders (ASX:AXP) said that a retrospective clinical study has concluded that the use of its AeroForm tissue expanders may be associated with reduced infection rates, less medical treatment and lower costs for patients and health systems.

The Palo Alto-based company makes the AeroForm tissue expander for post-mastectomy breast reconstruction. The device is designed to expand and stretch the skin and underlying muscle prior to a permanent breast implant using small amounts of CO2 up to three times a day.

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OptiScan raises $20m for bedside glucose monitoring system

OptiScan Biomedical said today that it closed a $20 million Series E round to support the commercialization of its continuous monitoring system, the OptiScanner 5000, in the U.S.

The company’s device is an automated bedside blood glucose monitor designed for use in the intensive care unit. The system can measure glucose values from a micro-sample of blood without the need for calibration, according to OptiScan.

Get the full story at our sister site, Drug Delivery Business News.

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GE Healthcare adds Adventist Health to hospital collaborator list

GE Healthcare has signed an agreement to provide advanced analytics and reduce process variation for the 21-hospital Adventist Health system in California, Oregon and Hawaii, the health system announced.

The five-year collaboration is designed to maximize the capacity of Adventist’s clinical assets and improve patient care delivery.  Adventist said it expects the collaboration to spur growth and reduce costs by more than $100 million over five years.

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Wireless preemie monitoring system allows more parental contact

A tiny participant in the Northwestern University study of a wireless NICU monitoring system. (Image courtesy of Science, per a Creative Commons 4.0 license)

A new, less invasive system for monitoring preterm and critically ill newborns’ vital signs would allow parents skin-to-skin contact with their babies when they otherwise couldn’t have it.

The system, designed by researchers at Northwestern University in Chicago, uses ultrathin, skin-like electronic sensing technology to overcome the limitations of traditional systems that require a large number of wired sensors. The researchers developed a pair of sensors that only require water to adhere to a newborn’s fragile skin and allow for untethered monitoring of key vital signs and can streaming data wirelessly it in real time to external devices.

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Medtronic inks 5-year value-based healthcare deal with S.C. hospital

Medtronic logo updated

Medtronic (NYSE:MDT) said today that it inked a five-year value-based healthcare partnership deal with the Medical University of South Carolina, looking to improve health outcomes, patient care experiences and reduce costs.

Fridley, Minn.-based Medtronic said the partnership will initially focus on addressing chronic disease and acute conditions prevalent in the region.

An initial program involves standardizing a vascular disease care pathway across the continuum of patient care and implementing a model for identifying, diagnosing, treating and follow-up care for patients with vascular disease.

The two groups also plan to implement a standardized care pathway program for joint replacement patients addressing the bundled payment methodology used by the Centers for Medicare and Medicaid Services.

“This strategic partnership with Medtronic is based on our shared vision and drive to lead the transformation of health care delivery. It’s about providing what’s best for our patients. The mutual goal of our organizations is to deliver the best patient outcomes at the lowest cost possible. That’s the true meaning of value-based health care. Through our collaborative partnership, we plan to combat chronic disease and address community health needs in South Carolina and beyond. We look forward to an innovative and productive relationship with Medtronic and will share tangible results of our efforts as our strategic partnership evolves,” MUSC prez Dr. David Cole said in a press release.

“Together with MUSC, we are committed to fundamentally improving the way patient care is delivered. Medtronic has a long history of collaboration with health care providers to invent and develop new markets to solve a variety of clinical problems. The partnership with MUSC is an extension of that collaboration, as we look to systematically work together to develop scalable programs aimed at improving patient outcomes while reducing the cost of care,” CEO Omar Ishrak said in a prepared statement.

Last week, Medtronic said that it won expanded FDA approval for its Pipeline Flex embolization device.

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3M closes $1B M*Modal buy

3m M*Modal

3M (NYSE:MMM) said today that it closed its approximately $1 billion acquisition of health information tech developer M*Modal.

Franklin, Tenn.-based M*Modal develops cloud-based, conversational artificial intelligence-powered software platforms. The company’s products are intended to allow physicians “capture and improve the patient narrative,” to allow them to gain more face time with the patient and improve quality of care, St. Paul, Minn.-based 3M said.

Annual revenue for M*Modal’s tech business is estimated at approximately $200 million, 3M said in a press release. The company added that it plans to integrate the newly acquired tech into its health information systems.

3M said that the financial impact of the buy was included in its recently reported full-year 2019 guidance.

Shares in 3M have dropped 1.3% today, at $196.53 as of 10:55 a.m. EST.

Late last month, 3M reported flat fourth quarter profits for its healthcare business, but saw them rise overall for the year as it posted consensus-topping earnings for its last quarter and full 2018 year.

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Baxter cleared from DoJ antitrust saline probe


Baxter (NYSE:BAX) said yesterday that it has been cleared from a U.S. Dept. of Justice antitrust probe, launched in 2017, investigating companies that market intravenous saline solutions.

The probe came as hospitals endured a shortage of intravenous saline solutions, which are used to hydrate hospital patients. The shortage dates back to late 2013, after drugmakers told hospitals they might experience delays in deliveries of saline.

 Read the whole story on our sister site, Drug Delivery Business News

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Baxter acquires software developer True Process

BaxterBaxter (NYSE:BAX) said last week that it acquired healthcare software developer True Process.

The company’s Vines software platform is designed for bedside data collection and normalization, according to a report from BizTimes.

Founder Todd Dunsirn, who reportedly left the firm after the acquisition closed, told BizTimes that the company’s software aims to connect the various devices that monitor and collect patient-related data in a hospital.

At one time, True Process had roughly 50 employees – half of whom worked remotely for client ICU Medical – and pulled in $10 million in revenue.

Most of the company’s remaining employees were hired at Baxter following the buyout, according to Dunsirn.

“We acquired True Process because we share a passion for innovative technologies that advance smarter and more personalized care,” Baxter said in prepared remarks.

Earlier this month, Baxter launched an FDA-cleared trial of its on-demand peritoneal dialysis solution generation system that’s designed to allow patients to make peritoneal dialysis solutions in small batches at home.

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Philips touts new gantry design for Azurion

Philips Azurion with FlexArmPhilips (NYSE:PHG) today touted the launch of its Azurion with FlexArm, which the company said enables physicians to more easily perform image-guided procedures.

As the clinician moves the system, the image bean maintains alignment with the patient and provides consistent visualization, according to Philips.

Azurion with FlexArm moves on eight axes, controlled by the Axsys controller. In simulation tests, use of the system significantly reduced patient repositioning. This is of particular importance during minimally invasive procedures that require access through the patient’s wrist, Philips said, because it reduces the risk of unintentional pulling of wires and tubes.

Philips launched Azurion in February of 2017 and more than 450,000 people have been treated around the world since then, according to the Amsterdam-based company.

“With FlexArm, Philips’ engineers have overcome near-impossible geometric and mechanical barriers to enable clinicians to achieve clinical excellence in image-guided therapy,” Dr. Barry Katzen, founder & CMO of the Miami Cardiac & Vascular Institute, said in prepared remarks.

“FlexArm enables us to dramatically optimize procedures around the patient: we can get the optimal view of what’s going on inside the patient without encumbering all of the clinicians that are working around the table. The result is an innovation that’s not only clinically important but also very simple and intuitive to use – a critical factor in the heat of a complex procedure,” Katzen added.

“Two years on from its launch, Azurion is now established as our leading platform for interventional procedures, favored by clinicians for its intuitive, seamless approach that enables them to focus on treating the patient, and by hospital administrators for its positive impact on productivity and efficiency,” Ronald Tabaksblat, business leader for Philips’ image guided therapy systems unit, said. “FlexArm is the natural next step in our Azurion innovation journey, combining clinical and operational benefits to improve patient care and reduce costs, while opening up opportunities for new image-guided procedures as the field continues [sic] grow.”

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