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.

ADDITIONAL LINKS

SOCIAL TAGS

#BugsNotDrugs
#PowerOverPain
#OptionsNotOpioids
#WhatWorksForComfort

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

By Maria Thacker Goethe May 8, 2025
Disclaimer: This statement was published on May 9, 2025, at 12:11 PM and is subject to change as the administration moves forward with policy decisions. -- In a rapidly developing situation, the White House is poised to take executive action on prescription drug pricing that could significantly impact the biopharmaceutical industry. Early next week, the president is expected to sign an executive order directing administration officials to pursue a "Most Favored Nation" initiative, which would tie U.S. government drug payments to lower prices paid abroad, according to sources familiar with the matter who were granted anonymity to discuss internal deliberations. This executive order would bypass the legislative discussions previously reported in Congress, where Republicans on the House Energy and Commerce Committee had been considering similar measures as potential spending cuts. While the plan hasn't been finalized and could still change as officials work through specifics, the move signals the administration's intent to act quickly on drug pricing. If enacted, the MFN policy could be paired with other proposed changes, such as increasing the 23.1% Medicaid base rebate. Reports suggest that manufacturers might be required to pay either the MFN price or the higher rebate—whichever yields the lowest cost for the government. This policy would create severe financial pressure on drug developers, particularly small and mid-size companies that are essential to Georgia’s thriving life sciences ecosystem. Georgia is home to a growing network of biotech, pharmaceutical, and medical technology firms—many of which are advancing groundbreaking treatments for rare diseases, pediatric conditions, and underserved populations. These companies often operate with little commercial revenue and rely on a balanced, predictable pricing framework to continue investing in innovation. In 2023, pharmaceutical companies provided $54 billion in Medicaid rebates nationally, helping keep drug spending to just 5.9% of total Medicaid expenditures . The current system works by ensuring broad patient access to medicine while enabling companies to reinvest in research and development. Drastic changes such as MFN pricing would upend this balance and threaten job creation and investment in states like Georgia. Moreover, because Medicaid rebate amounts are tied to 340B discount calculations, the impact would extend far beyond Medicaid—further increasing costs in the already-burdened 340B program. In response, Georgia Life Sciences has joined a coalition of more than 40 state bioscience associations, signing onto a letter from the Council of State Bioscience Associations (CSBA) opposing any MFN or foreign reference pricing schemes. The letter highlights the harm such policies would inflict on rare disease patients, pediatric populations, and emerging biotechnology companies. “Rather than penalizing innovative companies that develop treatments for vulnerable patients, we should work together to ensure the U.S. maintains its strategic leadership in biopharmaceutical innovation and that American patients have access to the best treatments available.” — CSBA Letter, May 2025 Georgia Life Sciences is actively monitoring the situation and preparing to advocate on behalf of Georgia’s life sciences community.
By Sheran Brown May 1, 2025
Opinion: Georgia's Congressional delegation can lead the way on correcting 'pill penalty'  Maria Thacker Goethe President and CEO, Georgia Life Sciences: May 1, 2025 EPIC Act offers commonsense fix to 'pill penalty' problem
By Maria Thacker Goethe April 18, 2025
The Science & Community Impacts Mapping Project (SCIMaP) shows how proposed federal funding cuts lead to reduced economic activity and job losses nationwide.
MORE POSTS