by Medgadget Editors | Jun 18, 2019 | Biopharma, FDA, Medical Device
Infusion pumps have been known to be a vector for a variety of medical mistakes, primarily adverse drug events. This has become such an issue that a few years ago the FDA began its Infusion Pump Improvement Initiative. One of the results of this program was the establishment of new requirements, aimed at reducing errors, for the manufacture of infusion pumps. Ivenix, a company based outside of Boston, just received FDA clearance for its Ivenix Infusion System that was envisioned, designed, and manufactured with the new requirements in mind.
The product is a large-volume infusion pump that features proprietary adaptive flow control technology that measures the fluid moving through the pump and adjusts its action in real time. This helps to eliminate the chance of free flow and nearly guarantees that the proper amount of fluids is administered throughout treatment.
Operating the pump was designed to be reminiscent of how one uses a smartphone, which helps to make things intuitive, reduces setup time, and minimizes errors and alarms. Ivenix believes that the benefits the pump delivers should lead to savings associated with reduced error rates.
Additional features of the Ivenix Infusion System include a wide range of administration sets and a management suite that lets clinicians remotely monitor infusions and be notified of any problems.
“For years, I’ve studied smart infusion pump safety and efficiency,” said Karen Giuliano, PhD, RN, FAAN, Associate Professor and Executive Director of Healthcare Innovation at Northeastern University Bouvé College of Health Sciences, in a press release. “My research has focused on revealing the serious usability challenges, which exist in the most commonly used IV smart pumps. Data suggest that the Ivenix Infusion System can enable clinicians to more quickly administer IV medications with significantly fewer errors compared with today’s leading pumps. Nurses, and the healthcare industry as a whole, have been waiting for an innovative solution like this.”
Flashback: The Ivenix Infusion System for Enhanced Delivery: Interview with Stuart Randle, President and CEO of Ivenix
Product page: Ivenix Infusion System
Via: Ivenix TrendMD v2.4.6
Source: Ivenix Infusion System Designed to Reduce Medication Errors is FDA Cleared
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by Jose Bolanos MD | Sep 5, 2014 | Angel Investors, Medical Device
eNeura nears the close of a $6.6 million equity funding round in supports of its home migraine therapy device.
Maryland-based migraine devices maker eNeura is closing in on a $6.6 million funding round, with $5.8 million raised so far.
The company has sold equity to 67 investors so far in a round launched on Aug. 18, 2014, according to an SEC report filed last week. There’s no minimum investment for outside investors, according to the report.
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eNeura’s device is the 1st of its kind to use transcranial magnetic stimulation to depolarize neurons on the brain, a process that doctors believe may interrupt migraine activity. Designed for home use, patients place the device against the back of the head, where a magnetic pulse targets the occipital lobe.
The device won FDA approval in May with positive results from eNeura’s double-blind, placebo-controlled studies in more than 200 patients, which found that nearly 38% of eTMS patients were pain-free 2 hours after using the device, compared with only 17% of patients in the control group. About 34% of eTMS patients were pain-free after 24 hours, compared with 10% of the control patients. Researchers reported no device-related serious adverse events.
Source: http://www.massdevice.com/news/eneura-raises-58m-home-migraine-device?utm_medium=referral&utm_source=pulsenews
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by Jose Bolanos MD | Sep 5, 2014 | Medical Device, Uncategorized, Venture Capital
Madison, Wisconsin-based Propeller Health, formerly known as Asthmapolis, has raised $14.5 million in a round of funding led by Safeguard Scientifics with participation from return backer The Social+Capital Partnership. Propeller has also hired Practice Fusion’s Chris Hogg as its first COO, and he’ll head up the company’s new San Francisco office.
The smart inhaler company’s devices and companion apps offer geographic mapping of inhaler use and asthma triggers as well as adherence tracking and early warning alerts for COPD patients.
“The funding supports the mission we are already on: to bring sensors to the full variety of the inhaled medications that are used for chronic respiratory disease,†Propeller Health CEO David Van Sickle told MobiHealthNews in an interview. “We are already well down that path… but the respiratory pipeline is fairly active. We are seeing new medications, therapies, and form factors.â€
In May Propeller received FDA clearance for its COPD offering. The new platform aims to help users prevent so-called “asthma attacks†or similar lung inflammation symptoms caused by COPD. The Propeller Metered-Dose Inhaler measures a patient’s use of their rescue inhaler. That data is automatically compared to a patient’s baseline and to general clinical guidelines, and the app can alert care teams if an attack seems likely.
“In addition software development, as we take on more COPD programs, we have a broad spectrum of demographics that we have to cover with our products and services,†Van Sickle said. “So we are building out teams to support the usability and experience of not only kids with respiratory disease but elderly folks with respiratory disease, caregivers, new enterprise teams for care managers which are on their own evolving with the times and new healthcare arrangements.â€
Propeller is also using some of the funds to build out its client services teams and sales staff, which has been relatively small to date, Van Sickle said.
One of the company’s recently announced customers was an accountable care organization partly owned by Propeller partner Dignity Health: Arizona Care Network, an ACO formed by Dignity Health and Tenet’s Abrazo Health, recently announced that it would offer its chronic obstructive pulmonary disease (COPD) patients the FDA-cleared, wireless-enabled inhaler and companion program developed by Propeller. The deal marked the first ACO deal for Propeller and one of the few publicly disclosed mobile health customer wins involving an ACO.
“We are [seeing interest from other ACOs] but it depends a lot on what type of ACO, right?†Van Sickle said. “[It depends on] how far they are along in their own life course and whether they have developed a budget for innovations investment yet. For a while there was just a lot of groundwork that needed to be laid down to make those kinds of investments. Now we are seeing that change a bit.â€
Propeller is seeing a lot of interest in COPD programs, Van Sickle said, partly driven by the market forces in healthcare incentivizing providers to reduce readmissions for COPD patients in particular.
Propeller’s new Chief Operating Officer — the company’s first ever COO — was Practice Fusion’s Associate Vice President of Data Sciences. Hogg joined Practice Fusion in early 2013 after the company acquired his consumer-facing startup 100Plus, which was incubated at Practice Fusion and partially funded by Practice Fusion CEO Ryan Howard, but otherwise a separate business pre-acquisition.
“Chris brings first and foremost a really interesting mix of skills and experience — both the academic experience he’s had and the commercial experience in pharma, data analytics, and fielding a digital health company,†Van Sickle said. “For me [Chris’ hire] echoes and foreshadows a shift in digital health toward the therapeutic approach and how we need to build digital health interventions that — hopefully — have a real focus on delivering improvement and outcome and less on engagement for its own sake. Chris has lived and practiced a lot of what we are trying to do and he has the operating mojo that we want to bring to this company. He’s a great fit and we’re really excited to have him.â€
Source: http://mobihealthnews.com/36285/propeller-health-raises-14-5m-taps-chris-hogg-as-coo/
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by Jose Bolanos MD | Aug 19, 2014 | Medical Device
14 August 2014
US-based TMJ Health has launched TMJ NextGeneration, a FDA-cleared medical device that will be used to reduce temporomandibular joint disorder (TMJD) pain.
The two custom-made, hollow ear canal inserts featured in the device enable the full passage of sound, and are said to be invisible from the outside.
TMJD, which is a group of painful conditions, affects the jaw joint and surrounding muscles and nerves. Even though TMJD is not life threatening, the disorder can be detrimental to quality of life and the symptoms can become chronic and difficult to manage, the company said. “The symptoms of TMJD include jaw pain, stiffness, clicking and locking, chewing difficulty, and migraines.” The symptoms of TMJD include jaw pain, stiffness, clicking and locking, chewing difficulty, and migraines.
According to the National Institute of Health, TMJD could afflict more than 35 million people in the US, the majority of whom are women aged between 20 and 40. TMJD has often been treated with bite splints, which are plastic mouthpieces that fit over the upper or lower teeth to prevent them from coming together and reduce the amount of clenching or grinding.
LSCI president and board-certified toxicologist Roger Wixtrom said: “While bite splints have helped to reduce pain associated with TMJD, there are drawbacks with these devices. “For example, they cannot be worn while eating and they can also affect speech, and as such are typically only worn at night while sleeping.
“The TMJ NextGeneration device offers a safe and effective option that patients should discuss with their dentist or ENT.”
The TMJ NextGeneration hollow ear canal inserts are located very close to the temporomandibular joint, and the volume of the ear canal increases when the jaw is opened through movements such as chewing, smiling and speaking. The device uses this anatomical change to provide a unique near-field treatment for TMJD. In a three-month clinical study, patients wearing the device experienced a significant reduction in the pain and dysfunction associated with TMJD, to an extent at least as much as that experienced by patients wearing a bite splint, the company claimed.
Image: TMJ NextGeneration is a first-of-its-kind, FDA-cleared medical device that is a safe and effective aid in reducing TMJD pain. Photo: courtesy of TMJ Health, LLC.
Source: http://www.medicaldevice-network.com/news/newstmj-health-introduces-tmj-nextgeneration-device-to-treat-temporomandibular-joint-disorder-4343866?utm_medium=referral&utm_source=pulsenews
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by Jose Bolanos MD | Jun 27, 2014 | Medical Device, Regenerative Medicine
A Leap Of Faith Recap: Dr. Macchiarini & Pioneering Regenerative Medicine (6/27/14)
Pioneers in the history of mankind have never been fully recognized until generations that came after them finally reaped the benefits of what they courageously started. Today’s NBC News Special had Meredith Viera tracking the people involved in treading a new frontier in science: regenerative medicine or what is also known as stem-cell tecnology. This new field is indeed a leap of faith, especially for Italian surgeon and scientist Dr. Paolo Macchiarini (photo in this recap) whose quest to save the lives of people prompted him to venture into what is otherwise the unthinkable.
The Man Who Defied Uncertainty
Dr. Macchiarini is considered a pioneer in regenerative medicine and tissue engineering who specializes in tracheal transplantation. Currently a Professor of Regenerative Surgery at the Karolinska Institutet in Stochkholm, Sweden, he has spent at least 26 to 27 years of experimental research in a field where skeptics abound. His work has given him the conviction that artificially grown organs can be transplanted to humans and let their stem cells regenerate. This is the biggest hope anyone could ever give to people who are left without any alternative from a medical perspective.
Described by others as a rogue and rebel, Dr. Macchiarini was willing to gamble his life and career because he believed that treatment is available; he only needed to take that one chance or simply let it pass away. For this surgeon, he couldn’t allow himself to simply give up and see human lives wither away.
Where The Critics Stand
A percentage of the population in the medical field have qualms about regenerative medicine simply because this is a gray zone (as quoted from Dr. Joseph Vacanti of the Massachusetts General Hospital for Children). They say that it his has a long way to go and it would take extensive research and tests before the risks are taken out and lives could actually be saved. They claim that regenerative transplant is impossible for whole organs and that Dr. Macchiarini is jumping the gun.
The Rebel’s Journey
2008 marked the year when Dr. Macchiarini first crossed a new frontier when he took on the case of Spanish mom Claudia Castillo who became a recipient of the first trachea radically grown in a laboratory. Six years after the surgery, Claudia is healthy and living her fresh lease on life. Claudia’s case also proved that Dr. Macchiarini’s medical breakthrough can avert a body’s rejection of an implant.
In 2010, the surgeon handled his first case on a child, then 10-year old Ciaran Finn-Lynch. Ciaran’s case showed that Dr. Macchiarini’s method was more promising for children with their ability to regenerate and heal faster. By 2011, Dr. Macchiarini embarked on the utilization of a man-made trachea entirely created from plastic. His first recipient was 36 year-old Eritrean Andermariam Beyene.
Not all of Dr. Macchiarini’s cases can be said as success stories, but the process he went through encouraged him to review and enhance his methods.
Stumbling Blocks
Christopher Lyles was the first American to undergo Dr. Macchiarini’s method. Since regenerative surgery was still unauthorized in the US, Chris travelled all the way to Stockholm in the hopes of a solution to the threat of his inoperable throat tumor. His doctors in Baltimore may have been doubtful of the operation’s success but Chris and his family had faith in the procedure. For Chris, his venture may or may lead to success but his desire to bring elevated awareness on regenerative medicine in the US was more than enough to take the risks with Dr. Macchiarini. The operation was a success but Chris only lived for another 4 months due to pneumonia.
Hannah Warren became Dr. Macchiarini’s youngest patient who paved way for a major shift in regenerative surgery outlook in the US. Hannah had to go through a difficult time waiting for a hospital that would allow the procedure even if Dr. Macchiarini was ready to work on her case. She found emotional, moral and financial support from the nuns and medical staff (particularly Dr. Mark Holterman and Dr. Rick Pearl) of the Children’s Hospital of Illinois. Hannah’s case became the turning point to gain an FDA approval.
When Dr. Macchiarini finally got to evaluate Hannah’s case, he knew that the procedure would become very risky due to the problems posed by Hannah’s missing windpipe and a complex congenital problem. Hannah’s parents were undaunted; by taking a chance on Dr. Macchiarini, they had hopes that their little girl has a chance of living a life outside the confines of a hospital where she practically lived all her life. Unfortunately, the complications that came with the risks only provided the 2-year old another 3 months to live after her first surgery.
The Road Ahead
Among his patients, Hannah had the biggest impact on Dr. Macchiarini from an emotional, professional and ethical standpoint. His empathy for Hannah fuelled him to do everything he could but her death made him question the decisions he’s made so far. It came to a point that he wanted to stop as losing lives didn’t make sense anymore.
Dr. Macchiarini never saw the support that came pouring in: from the families of Chris Lyles and Hannah as well as people who were critical of his ventures. Dr. Vacanti finally yielded that Dr. Macchiarini may have done experiments that were risky and dangerous but he did the right thing for surgical innovation.
Dr. Macchiarini’s experience with Chris and Hannah energized him to enhance his technology and better his success rate on his patients.
That’s our recap of A leap of Faith: A Meredith Viera Special today, 06/27/14.We’ll be back next week as we recap Dateline NBC. Until then, please check out our Dateline NBC archives HERE.
Image credit:Â NBC News
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by Jose Bolanos MD | Apr 24, 2014 | FDA, Medical Device
FDA released a new expedited access for PMA Medical Devices for life threatening or irreversibly Debilitating Diseases.
Expedited Access for Premarket Approval Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions – Draft Guidance for Industry and Food and Drug Administration Staff
This draft guidance, when finalized, will represent the Food and Drug Administration’s (FDA’s) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance.
Expedited Access for PMA Guidelines
The Food and Drug Administration (FDA or the Agency) is proposing a new, voluntary program for certain medical devices that demonstrate the potential to address unmet medical needs for life threatening or irreversibly debilitating diseases or conditions and are subject to premarket approval (PMA) applications. FDA believes that the “Expedited Access PMA for Unmet Medical Needs for Life Threatening or Irreversibly Debilitating Diseases or Conditions” (“Expedited Access PMA” or “EAP”) program will help patients have more timely access to these medical devices by expediting their development, assessment and review, while preserving the statutory standard of reasonable assurance of safety and effectiveness for premarket approval,1 consistent with the Agency’s statutory mission to protect and promote public health.
As part of this EAP program, FDA intends to provide, as resources permit, more interactive communications during device development and more interactive review of Investigational Device Exemption (IDE) applications and PMA applications.  In addition, FDA intends to work interactively with the sponsor to create a data development plan specific to the device (“Data Development Planâ€).  This Data Development Plan should outline all data the sponsor intends to collect in support of device approval, including what data will be collected premarket and postmarket.
FDA’s proposed EAP program contains features from CDRH’s Innovation Pathway, piloted in 2011 to facilitate the development and expedite the review of breakthrough technologies.2 In addition, the proposed EAP program is based in part on FDA’s experience with the Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation (CBER) programs that are intended to facilitate and expedite development and review of new drugs to address unmet medical needs in the treatment of serious or life-threatening conditions (“FDA drug expedited programsâ€).3 However, while the EAP program incorporates some features of the Drug expedited programs, it is a separate and distinct program tailored to devices and intended to further speed the availability of certain safe and effective medical devices that address unmet public health needs.
FDA’s guidance documents, including this one, do not establish legally enforceable responsibilities. Instead, guidance documents describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance documents means that something is suggested or recommended, but not required.
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