By Yuika Yoshida, Orange County Business Journal 

Could ‘Revolutionize’ Neonatal Care, CEO says

IRVINE – Makani Science is one step closer to commercial launch.

The Irvine medtech company last month received 510(k) clearance from the Food and Drug Administration for its wireless, wearable respiratory monitor in adults.

“It shows that our device not only works as we say it does, but it shows that it’s safe, it’s accurate and at least equal to current devices that are on the market,” Chief Executive Greg Buchert told Makani’s respiratory monitor is a small stretch sensor made of plastic sheets that shrink when heated.

The company has raised more than $3.5 million to date, including a recent $1.1 million grant from the National Institutes of Health.

With approval, commercialization could begin as early as the fourth quarter of this year, according to Buchert.

 15-Month FDA Delay

It took about 15 months to get approval, Buchert said.  The process was delayed due to the FDA changing its standards, forcing the company to repeat its clinical trials and meet new cybersecurity requirements.

“We performed, we executed and we got the clearance,” Buchert said.

Makani was co-founded in 2019 by Michelle Khine, a biomedical engineering professor at the University of California, Irvine, and her post-doctoral student Michael Chu, who is now chief technology officer.

Its respiratory monitor is intended to be worn on the abdomen.  Data is then transmitted to the user’s phone via Bluetooth, eliminating the need for wires and making it possible for people to wear on the go.

“There are continuous respiration monitors, but they don’t work well during motion,” Buchert said.

 $1.1M Grant from the NIH

Makani also received a $1.1 million grant from the NIH the same month it got the FDA approval.

It was awarded by the NIH’s National Heart, Lung and Blood Institute to classify and prevent apnea of prematurity, a condition where newborns suddenly stop breathing for short periods of time.

Babies rarely die from the episodes, but research shows that they’re later associated with delays in intellectual language and motor development depending on the frequency and duration of the apnea.

Nearly half of babies born before 35 weeks will experience apnea of prematurity, according to Buchert.

The grant will help fund the development of a second-generation version of the company’s device that will measure respiratory rate, but very few track volume, he said.

Makani is conducting the study in partnership with Dr. Terrie Inder, a director of neonatal research, at Children’s Hospital of Orange County, which merged with Rady Children’s Hospital San Diego to create a new combined entity called Rady Children’s Health.

The second-generation device will be modified with a stimulator so that after identifying a pause in breathing, it can stop the apneic event.

Eventually, the company’s goal is to apply a machine algorithm to the device to see what’s causing apneic events and, if possible, stop them before they occur, Berchert said.

“This could be revolutionary in neonatal medicine,” he said.

Click here to read full Orange County Business Journal article.

Makani Science Receives FDA Clearance for Groundbreaking Respiratory Monitor

Irvine, Calif. – April 2, 2025 – Makani Science, an innovator in wearable respiratory monitoring technology, today announced that it has achieved 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market and distribute its Makani Respiratory Monitor.

This clearance validates patient safety, as well as the accuracy and reliability of Makani’s innovative device, which is designed to continuously monitor respiratory rate in real time. The Makani Respiratory Monitor underwent comprehensive and rigorous testing and evaluation, successfully demonstrating its performance in a variety of clinical and real-world settings This 510(k) clearance is a significant milestone for the company, providing premarket approval for the Makani Respiratory Monitor.

This small comfortable unique monitor enables monitoring of ambulatory individuals rather than being hampered by wires. The monitor can provide continuous real-time information to iOS devices that can be accessed by patients and their healthcare providers. The immediate availability of respiratory performance provides an advantage over other respiratory monitors that provide delayed information.

“FDA clearance opens the door to commercialization, clinical integration, and strategic partnerships,” said Greg Buchert, MD, MPH, and CEO of Makani Science. “It’s not just a regulatory win—it’s a strong endorsement of the technology we’ve worked tirelessly to develop and refine. As a physician, I am confident we will improve the health and lives of individuals who use the Makani Respiratory Monitor.”

With FDA clearance secured, Makani Science is moving forward with manufacturing, early clinical deployments, and research collaborations. The device is poised to support applications in hospitals, outpatient clinics, athletic performance monitoring, and early disease detection—anywhere continuous, non-invasive respiratory monitoring can make a meaningful difference.

About Makani Science

Makani Science (www.makaniscience.com) is a medical technology company based in Irvine, California specializing in wearable, real-time respiratory monitoring. Its flagship product—the Makani Respiratory Monitoring System—delivers accurate, continuous tracking of respiratory rate in a lightweight, wireless design. The company is focused on transforming how breathing is monitored across clinical, research, and performance settings. Makani Science is on a mission to help millions breathe better through smarter, non-invasive monitoring solutions. Contact Dr. Greg Buchert (greg@makaniscience.com) for more information.

Click here to read full press release.

By Cassandra Nava, UC Irvine Samueli School of Engineering

April 2, 2025 – Drone demos, virtual reality goggles and miniature robots were just a few of the 200 projects on display at the Samueli School of Engineering’s Annual Design Review on Friday, March 14. Around 1,000 engineering students from the school’s six departments filled up the UC Irvine Student Center where they presented their group projects.

The senior design program gives fourth-year engineering students an opportunity to address real-world problems with innovative ideas for creative solutions. After working in teams on their projects for two quarters, students are then able to present their ideas by displaying or demonstrating them to a wider audience at Design Review. The annual event allows students to practice their presentation and networking skills, as they share their projects with alumni, industry professionals, faculty, fellow students and staff.

Engineering Dean Magnus Egerstedt welcomed everyone and encouraged students to enjoy the event. “You’ve been in classrooms, internships, all sorts of things, but this is where the rubber hits the road,” said Egerstedt. “This is where the magic is, where you show off what you’ve learned. This event right here is what the value of an Anteater engineering education is all about.”

Project teams spanned over three rooms in the Student Center. Clever and ingenious solutions were offered for important and practical issues, like a smart pet feeder, elderly care alert bracelet and sign language robot. Students kept attendees engaged with their presentations and demonstrations of interactive devices like a playable computer keyboard connected to a harp or an instant smart water bottle that can test a pH level in seconds.

Around 40 guests attended the event, including Samueli Academy High School engineering instructor AJ Polizzi, who has attended regularly over the years, as it influences how he prepares his students.

“It gives me a chance to interact with current engineering students,” Polizzi said. “And we’re feeding back what you guys are doing here to help motivate our students to pursue that work in high school. We go back to the kids and say, ‘hey, look, this is what they’re doing over in college.’ We are teaching them the same lesson: going from an idea to a design to a product.”

The three-hour event ended with the announcement of the Dean’s Choice Awards. Of the 21 nominations, 12 projects were recognized. The dean and a team of graduate student judges selected the winners based on the following criteria: if the project solves an important problem, if it is practical and if it has the wow factor. Below are this year’s Dean’s Choice Award winners.

BIOMEDICAL ENGINEERING

EMG- FES: Rehabilitation & EMG-Assisted Control for Health (REACH) 

This project uses a patient-specific automated electrical simulation system to treat stroke victims’ hand contractures. Using AI techniques, the students hope to automate and improve stroke rehab and physical therapy.

Team members: Andrew Eck, HyungCheol Kim, Michael Song, Edmund Totah

J & J Medical Simulator: SimuMed Solutions  

The team won for their design of a model to help support catheter testing and improve catheter development safety through a realistic groin puncture model. The team — sponsored by Biosense Webster, a Johnson & Johnson MedTech company — won due to their accurate engineering methods in developing and testing materials.

Team members: Hanh Nguyen, Janelle Ho, Lanie Le, Nadeen Morsi, Raul Quintero, Charissa Taim

CHEMICAL AND BIOMOLECULAR ENGINEERING

Batch Distillation

Students in this team tackled challenges relating to sustainable energy and environmental protection by investigating batch distillation. The use of distillation can be applied to everyday uses and products like to separate components, purify products, or aid in the production of alcohol, fragrances and more.

Team members: Amy Fernandez, Salvador Martinez, Chloe Lee, Gordon Ko

CIVIL AND ENVIRONMENTAL ENGINEERING

Black & Veatch: OASIS Project

This project investigated the possibilities of utilizing secondary effluent, or treated wastewater, from a water reclamation facility to provide drinking water. The group of students found that this will drought-proof the water supply for climate change resilience. They also displayed their findings of water quality requirements, treatment technologies and permits and regulations needed to make this a reality.

Team members: Joshua Faith, Taylor Mangold, Monica Tith, Por Asvaplungprohm, Justino Lopez-Gonzalez

APEX Environmental & Water Resources Remedial Design and Implementation 

Students in this team were able to explore the field of environmental remediation, which is the process of restoring contaminated environments. The students utilized hands-on and real-world experience at a site with significant environmental contamination. The project identified site-specific challenges and evaluated various approaches and technologies.

Team members: Kendrick Pam, Ahtziri Meneses, Henry Rui Zhi Quan, Louwing Perez

ELECTRICAL ENGINEERING AND COMPUTER SCIENCE

Envision – Gesture Interface Device 

This team’s project aimed to solve the problems with enabling real-time AI for gesture recognition on devices with restricted storage and processing capabilities. The goal of the project was to help people not familiar with computers to have easier access to computing. The demonstration showed practical functionalities and input methods for applications.

Team members: Ally Liu, Derek Duy Dao, Gregory Shklovski, Yasper De Jong

Project Prometheus (Wildfire Detection System) 

A wildfire monitoring system using energy-efficient sensor packs was proposed by this team. The dangerous issue of wildfires was addressed by the students, as they considered the challenges that remote areas face with early detection.

Team members: Andy Yang, Cem Babalik, Jaime Rodriguez, Kenny Lai 

Glove Band (Air Violin) 

The students in this team created a glove that allows the wearer to “play” violin with just hand movements. The sensor-embedded glove translates user movements into musical notes, which are processed by a microcontroller and output from a speaker.

Team members: Tangqin Zhu, Canting Zhu, Zhengyang Zhuang, Thomas Yeung, Aarav Awasthy

MECHANICAL AND AEROSPACE ENGINEERING

Fluid Powered Vehicle Competition (FPVC) 

The Zotdraulics team built a vehicle that runs on hydraulic and pneumatic power via human input. The students represented UCI in its first entry into the Fluid Power Vehicle Challenge sponsored by the National Fluid Power Association, whose goal is to further fluid power technology.

Team members: Adrian Jimenez, Ben Trejo, Elaine Kwok, Ian Lin, Karen Gines, Steven Tsui

UCI CanSat 

The annual international engineering challenge, CanSat asks student teams to design and build a space-type system. This year they designed a container deployable from a rocket with controlled descent rates. Last year, the team placed second in the U.S. and fourth worldwide.

Team members: Kaylee Kim, Khushi Gupta, Sarah Ho, Brady Cason, Naethan Fajarito, Timothy Yee, Diane Yoon, Andrei Darujuan, Felix Jing, Zhanhao Ruan

UAV Forge

This team developed an autonomous aerial vehicle to compete in the international RoboNation Student Unmanned Aerial Systems competition. The students hope their aircraft design will outperform their entry in last year’s competition, where they placed in fourth place nationwide.

Team members: Silvia Tinelli, Ozzy Sanchez-Aldana, Eesh Vij, Anthony Tam, Trung Huynh, Isaiah Jacobs, Eric Pedley, Octavio Partida, Philip Jian

MATERIALS SCIENCE AND ENGINEERING

JPL: Designing Crushable Lattices for Terrestrial Hard Impactors 

Team members in this NASA JPL-sponsored group set out to find solutions for a low-cost hard landing of mission architecture. This is relevant for when rocks samples from Mars are brought to Earth. Students developed a lattice structure that will absorb energy from a hard landing.

Team members: Andy Chen, Timothy Dang, Bryan Gong, Joelene Velasco, Martin Zhong

Click here to read full article on the UC Irvine Samueli School of Engineering website.

 

UC Irvine Magazine | Winter 2025

Three to five out of every 1,000 babies are born with a port-wine birthmark, a splash of red or purple on the skin somewhere on the body, mostly commonly the face. Unlike smaller, lighter birthmarks, port-wine marks can darken, thicken and develop complications such as bleeding and infections – and may be associated with other conditions like glaucoma and even seizures.

“They can also impact a person’s social interactions and psychological well-being, particularly when they cover a sizable portion of the face,” says Dr. Kristen Kelly, UC Irvine professor and chair of dermatology.

Using a pulsed dye laser, she zaps the purple-tinted blood vessels, heating them with intermittent bursts of light until the blood flow stops and the vessels break or develop clots and resolve. The targeted therapy sometimes requires as many as 30 treatments to effectively lighten a port-wine birthmark.

UC Irvine scientists have been at the forefront of addressing these signature marks for more than a decade. Dr. J. Stuart Nelson, medical director of the Beckman Laser Institute & Medical Clinic, pioneered the first cooling laser device in 1994, revolutionizing treatment for individuals with port-wine birthmarks. The cooling device protects the surface of the skin, allowing doctors to safely deliver higher doses to event the youngest patients while minimizing the possibility of complications. Depending on the size and depth of the blood vessels, many people experience dramatic benefits.

Unfortunately, the discoloration sometimes reappears. “The risk of vessels returning is lower when we start treatment during the first year of life,” says Kelly, whose patients range from infants to individuals in their 90s. To reduce recurrence, UC Irvine researchers are investigating approaches to combine lasers with medication. New medicines may need to be developed, Kelly adds.

These epidermal anomalies aren’t just a cosmetic concern. They can thicken the skin, produce nodules and, in some cases, affect the organs, including the yes or brain. “Since we don’t know which patients are going to develop progression or complications,” Kelly says, “it’s important for anyone who has a port-wine birthmark to seek car from a qualified expert.”

Author(s): Kristen Marie Kelly, MD, FAAD, Heidi Anne Duerr, MPH
Conference: American Academy of Dermatology

Expect exciting news in the treatment of port-wine birthmarks, Kristen Marie Kelly, MD, told AAD Annual Meeting attendees.

Kristen Marie Kelly, MD, FAAD, highlighted promising advancements in the treatment of vascular malformations, particularly port-wine birthmarks at the American Academy of Dermatology (AAD) Annual Meeting.¹ Although lasers have significantly improved patient outcomes, she said, some lesions remain resistant, and recurrence continues to be a challenge. However, Kelly said new research offers hope for more effective therapies.

According to Kelly, chair and professor of dermatology at the School of Medicine, University of California, Irvine, energy-based devices remain a cornerstone of treatment, but there are emerging strategies that involve combining them with targeted medications. In her talk, “What’s Next: Future Directions for the Treatment of Port Wine Birthmarks,” she explained a deeper understanding of the genetic mutations underlying vascular malformations is paving the way for innovative approaches. “Our treatments have improved, but for resistant lesions, there is hope for the future,” she said.

Recent studies have explored the potential of adjuvant therapies, including rapamycin and imiquimod, but these have produced only modest benefits, Kelly told Dermatology Times. However, ongoing aim to identify medications that more precisely target the affected pathways. Kelly said, “New drugs are being screened, and my hope is that when we find one that really targets that pathway, the combination will be very powerful.”

Kelly emphasized the importance of continued research and professional education. For those who want to be sure to stay up to date, she suggested attending conferences such as AAD Annual Meeting. The American Society for Lasers in Medicine and Surgery (ASLMS) is also a useful resource, she said, as they provide key platforms for dermatologists to stay updated on the latest advancements. “There’s a lot of research going on in terms of new potential treatments, and people should continue to watch for more exciting options,” she told Dermatology Times.

With the integration of genetic insights, novel therapeutics, and advanced laser technologies, the future of port-wine birthmark treatment is evolving and is promising, Kelly indicated. For dermatologists, she added, staying informed about these developments will be crucial in optimizing patient care and improving long-term outcomes.

For continued conference coverage, expert insights, and breaking news, subscribe to Dermatology Times eNewsletter.

Reference

1. Kelly KM. What’s Next: Future Directions for the Treatment of Port Wine Birthmarks. Presented at: the American Academy of Dermatology Annual Meeting; March 7-11; Orlando, Florida.

Click here to watch video and read full article in Dermatology Times.