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

GLS 2025 Year in Review

December 22, 2025
Dear Georgia Life Sciences Community, As we reflect on the past year, I want to extend my sincere thanks to our Georgia Life Sciences members for making it such an impactful one. Your engagement and leadership continue to move our industry forward and advance our shared strategic priorities— driving strong policy, expanding the talent pipeline, and creating intentional spaces for collaboration across Georgia’s life sciences ecosystem. Our Year in Review captures the progress we’ve made together across these priorities and highlights the collective impact our members are having statewide—from strengthening the workforce and supporting manufacturing growth to elevating Georgia’s position as a national life sciences leader. This progress is only possible because of the collaboration, commitment, and insight of our member community. 

Investing in America’s Biopharmaceutical Infrastructure Strengthens the Economy and Supports Union Workers

By Maria Thacker Goethe • December 20, 2025
The biopharmaceutical industry is growing America’s manufacturing and R&D capabilities to develop the next generation of treatments. A recent study from PILMA quantified the impact of the industry’s investment in American infrastructure on the economy and union workforce across 18 states from 2019-2024. The study found that across the 18 states included, the biopharmaceutical industry: Supported the American economy by investing $86.5B in R&D and manufacturing infrastructure and developing 1000+ construction projects at over 700 distinct facilities. Strengthened the American workforce by generating $2.6B in skilled union wages and providing $19M in support for union apprenticeships. The impact of the biopharmaceutical industry’s investment in American manufacturing and union jobs extends beyond direct benefits, spurring additional economic activity in the communities where workers live. This is known as the multiplier effect . On average, every $1 of new investment in a U.S. biopharmaceutical manufacturing facilities generates an additional $1.59 in further economic activity (2.59x times the initial investment value). The industry’s $86.5B investment in R&D and manufacturing infrastructure has a total economic impact of $224B. Check out this resource to learn more about how biopharmaceutical investment in American infrastructure supports America’s workers and communities. For more on how biopharmaceutical companies are investing in America’s future, visit innovation.org/america-investment .

Georgia Life Sciences Joins National Coalition Urging Congressional Action on Key Innovation Policies

December 10, 2025
Georgia Life Sciences has joined 43 state and regional life sciences organizations in signing a national Council of State Bioscience Associations (CSBA) letter calling on Congress to take immediate action on three bipartisan policy priorities that are essential to sustaining U.S. leadership in biomedical innovation and supporting patients nationwide. With Congress back in session and several critical programs at risk of expiring, the letter urges congressional leaders to advance the following provisions without delay: 1. Reauthorize the Rare Pediatric Disease Priority Review Voucher (PPRV) Program The PPRV program has been instrumental in incentivizing the development of therapies for children with rare and life-threatening conditions. Its lapse threatens to slow or halt research that families across the country are counting on. 2. Extend the SBIR/STTR Programs The Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs provide crucial early-stage capital for emerging biotech and medtech companies—many of them in Georgia. Without reauthorization, hundreds of innovative small businesses face uncertainty, jeopardizing new therapies, diagnostics, and technologies in the pipeline, 3. Advance PBM Transparency Reforms Greater transparency and accountability within pharmacy benefit manager (PBM) practices are needed to ensure that savings reach patients and employers. Reforming PBM operations is essential to strengthening access and affordability across the healthcare system. A Unified Message from the Life Sciences Community The sign-on letter reflects broad, bipartisan alignment across the national life sciences ecosystem: researchers, entrepreneurs, investors, patient advocates, and state associations all share a common message— these programs underpin America’s global competitiveness and are vital to patients who rely on continued scientific progress. Georgia Life Sciences has shared the letter with members of Georgia’s congressional delegation and will continue engaging with policymakers to emphasize the importance of swift action.
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