Control Dialysis Cannulation Pain – New Buzzy Pro Receives FDA 510K Indication

Dialysis cannulation pain impacts half a million patients. Proven Buzzy device is now FDA indicated to control dialysis, blood donation & lab draw needle pain.

ATLANTA, GEORGIA, U.S., July 12, 2023/ EINPresswire.com / — Dialysis patients can now get more pain relief during treatment thanks to Buzzy’s recently expanded FDA indications. Pain Care Labs has received augmented Section 510(k) clearance from the United States Food and Drug Administration (FDA) for the Company’s patented, noninvasive Buzzy devices to  control pain from dialysis.

“We already used the Buzzy bee for children, but not for adults. We did a little experiment to learn whether Buzzy would work on dialysis shunts,” explains Liesbeth de Boer, Nursing Improvement Advisor in Maastricht, Netherlands. “Several patients experienced less pain and were happy, so we introduced it in our dialysis department. Patients like the control of holding Buzzy in exactly the right spot for the best pain relief when the nurse places the needle.”

Based on feedback from healthcare professionals, the Company adapted the original Buzzy to work optimally for dialysis. Patented  Buzzy Pro  maximizes the mechanical stimulation and ice surface area to match an arteriovenous fistula or blood draw site.

Dialysis centers and home dialysis rarely provide topical anesthetic creams. “Creams take too long,” observes Amy Baxter, MD, “while reusable Buzzy works on contact.” Buzzy’s expanded indications include needle pain control for blood donation, lab draws, and dialysis.

Pain Care Labs has a pending application for coverage by Medicaid for dialysis patients to afford the Buzzy Pro pain relief device. Public comment for support or need with End-Stage Renal Disease (ESRD) is open through August 25, 2023. The ESRD rule is published, with the Pain Care Labs application summarized  on page 149. Interested parties, whether dialysis patients, their family members, or healthcare providers, are invited to comment here:  https://www.regulations.gov/docket/CMS-2023-0110/document

ABOUT PAIN CARE LABS

Pain Care Labs is the industry leader in non-invasive pain relief solutions. Established in 2006 by emergency physician and pain researcher Amy Baxter MD, the Company is dedicated to effective, reusable, drug-free pain solutions. Dr. Baxter speaks on public health topics including vaccine refusal (TEDMED) and the impact of needle fear on COVID vaccination (HHS). Most recently, she spoke at TED2023 about options instead of opioids after surgery. FDA-cleared Buzzy ® , the flagship product, has been used to block the pain from over 45 million needle procedures. FDA-cleared VibraCool ®  relieves musculoskeletal pain from injury and overuse. The Company’s award-winning solutions are supported by over 80 independent clinical trials. The patented M-Stim ®  neuromodulation platform gives power over pain.

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Raven Wilson
Pain Care Labs
+1 912-483-9490
email us here

Source: Dr. Amy Baxter and https://www.einnews.com/pr_news/643582048/control-dialysis-cannulation-pain-new-buzzy-pro-receives-fda-510k-indication

May 22, 2026
ALPHARETTA, Ga., May 21, 2026 (GLOBE NEWSWIRE) -- Micron Biomedical today announced the grand opening of its world-class manufacturing facility spanning more than 26,000 square feet in Alpharetta, Georgia. The opening marks the most advanced commercial-scale manufacturing site for Micron’s dissolvable vaccine and therapeutic technology in the world and positions the company for pivotal clinical trials that will accelerate the availability of needle-free vaccines and therapeutics that can be self-administered at home. “A significant body of evidence has shown that our dissolvable microarray technology is as effective as — or more effective than — conventionally injected medicines. Parents, patients, government officials, drug developers, public health leaders, and payers also prefer needle-free vaccines and therapeutics that are simpler and more cost-effective to transport and store,” said Steven Damon, CEO of Micron Biomedical . “Our novel technology requires equally innovative manufacturing equipment capable of scaling production, and this facility brings us one step closer to making that vision a reality.” Micron’s technology uses a dissolvable microarray “button” that is applied directly to the skin and, when pressed, painlessly delivers medications that dissolve in the uppermost layers of skin. The facility houses all of the equipment and manufacturing capabilities to design and produce Micron’s technology at scale including R&D facilities, wet labs, dry labs, storage and professional office spaces. Micron Biomedical’s grand opening ceremony was attended by business leaders, elected officials, investors, members of academia and other stakeholders. Representatives from the CDC were also in attendance as recently the CDC launched its first-ever clinical trial of a needle-free vaccine, evaluating a novel rotavirus vaccine, CC24, delivered via Micron Biomedical’s dissolvable microarray technology. The trial, at Emory University, builds on research, published in The Lancet, about self-administered seasonal influenza vaccine via Micron Biomedical’s dissolvable microarray technology, as well as studies across other disease indications, including measles and rubella . “Georgia is emerging as one of the country’s most important biotech manufacturing hubs, attracting talented scientists, engineers, business leaders and creating exciting economic and professional opportunities for our residents,” said Todd Jones, Georgia House Representative . “With its award winning first-in-the industry technology, Micron Biomedical is among the state’s leaders in simultaneously transforming the health of people around the world with never-before-possible access to medicine and vaccines - and in investing in the workforce of tomorrow with high paying jobs and growth opportunities." This year, published research reinforced consumer preference for microarray technology and Micron Biomedical was recognized as the number two most innovative company in its class by Fast Company for addressing global demand for simplified administration and distribution of vaccines and drugs. The scientific community support includes recent commentary in The Lancet which called Micron’s technology “game-changing in humanitarian settings.” Micron’s technology class has also been identified as the highest global priority innovation for overcoming immunization barriers in low- and middle-income countries by the Vaccine Innovation Prioritisation Strategy (VIPS) Alliance. “This milestone reflects the type of coordinated ecosystem growth outlined in Georgia Life Sciences’ recently released Roadmap for Georgia’s Life Sciences Sector — bringing together industry, startups, manufacturers, educators, investors, and policymakers to strengthen the state’s innovation and manufacturing capabilities,” said Maria Thacker Goethe, President and CEO of Georgia Life Sciences , who attended the ribbon cutting ceremony. “With this cutting-edge facility, Micron is helping advance Georgia’s position as a national leader in biotechnology, medical technology, and life sciences innovation while reinforcing the state’s role as a scale-up manufacturing hub for the Southeast.” “Ribbon cuttings are always special and momentous events, but this one is especially satisfying because it points to an infrastructure for pivotal clinical trials of technologies being studied at Emory that have the potential to save lives and reduce disease burden by expanding coverage and access to critical medications,” said Christina Rostad MD, pediatric infectious disease associate professor at Emory University and lead investigator of the CD244 trial who provided commentary remotely. “Our team at Emory University is excited to be a part of the celebration and look forward to continuing to explore the potential of Micron Biomedical’s dissolvable microarray vaccine technology.“ About Micron Biomedical Micron Biomedical is the leader in dissolvable microarray-based, drug and vaccine administration technology with a growing pipeline of needle-free versions of previously injectable-only medicines. Micron Biomedical is a clinical-stage life science company on a rapid path to commercializing its proprietary dissolvable, microarray technology. Micron’s technology is designed to improve access and achieve better health outcomes globally through injection-free, painless, and simple and/or self-administration of drugs and vaccines, and by eliminating or reducing the need for cold chain transport and storage, enhancing safety and efficacy, and improving patient compliance. Micron partners with and/or receives funding from private and public entities including pharmaceutical and biotech companies, the Gates Foundation, the Centers for Disease Control and Prevention (CDC), PATH and the Georgia Research Alliance. For more information visit www.micronbiomedical.com . Press Contact Shira Derasmo M: +1-917-280-2497 E: pr@micronbiomedical.com A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/31153de2-caed-4aa2-b291-ebeed2652b70 A video accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/d855a883-fb26-47ce-9831-8ef1e0b93f43 
May 13, 2026
Georgia Life Sciences thanks Dr. Marty Makary for his service as Commissioner of the U.S. Food and Drug Administration during a period of significant change across the nation’s health and regulatory agencies.
May 12, 2026
Georgia Life Sciences is pleased to announce Tim Opler as a featured keynote speaker at the 2026 Georgia Life Sciences Summit, taking place August 25-26 at the Sandy Springs Performing Arts Center in Atlanta. A leading voice in biotech investment banking, Tim Opler serves as Managing Director in Stifel’s Global Healthcare Group, where he advises innovative life sciences companies on financing, growth strategy, and market positioning across the healthcare landscape. Tim brings deep insight into the evolving biotech investment environment, emerging industry trends, and the factors shaping the future of life sciences innovation and commercialization. Join us for this timely discussion with one of the industry’s most respected financial leaders as we explore the opportunities and challenges defining the next era of life sciences growth . 
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