Regulatory Update

Washington, D.C. – – September 19, 2026 -- Advocates for limb-girdle muscular dystrophy (LGMD) held more than 60 meetings with congressional offices this week, representing patients from over 20 states, as part of The Speak Foundation's LGMD Day on the Hill.

No FDA-approved treatment exists for LGMD despite scientific progress

LGMD is a group of rare genetic diseases causing progressive muscle weakness, and no FDA-approved treatment currently targets the condition. Advocates urged lawmakers to increase federal investment in LGMD research, expand access to Department of Defense research funding, and push for clearer, more consistent regulatory pathways for rare-disease treatments.

Stony Brook – September 19, 2026 -- ZBeats Inc. has secured U.S. Food and Drug Administration 510(k) clearance (K261580) for its ZBPro Diagnostic v2.0 software, extending its independent ECG analysis platform to cover recordings ranging from one minute to 14 days.

FDA clearance broadens device compatibility to Holter monitors and wearable patches

The updated clearance allows ZBPro to process data from a wider range of recording technologies, including Holter configurations and wearable patch devices, positioning the software as a device-agnostic layer for cardiac diagnostics providers.

Washington – September 19, 2026 -- The U.S. Department of the Treasury has moved forward with fiscal year 2025 and 2026 awards across multiple Community Development Financial Institutions Fund programs, ending more than a year of advocacy by the CDFI industry for the release of the funds.

Opportunity Finance Network credits bipartisan pressure for the award release

Opportunity Finance Network (OFN), which represents nearly 500 CDFI members, said the announcement followed sustained lobbying by OFN, the broader CDFI sector, industry partners, and congressional champions from both parties. Harold Pettigrew, President and CEO of OFN, said CDFIs form part of America's economic and financial infrastructure, financing small businesses, affordable housing, and community facilities nationwide. "The CDFI Fund has earned broad bipartisan support because it produces measurable economic results in rural, urban, and Native communities alike," Pettigrew said.

Seoul – September 19, 2026 -- Hanwha Power has secured Approval in Principle (AiP) from the American Bureau of Shipping for a 22,000-cubic-meter LNG bunkering vessel concept design, the company announced on September 15 at GASTECH 2026 in Bangkok, Thailand.

Approval completes Hanwha Power's bunkering vessel lineup from 7,500 to 22,000 CBM

The certification rounds out a full range of medium- and large-scale LNG bunkering vessels for Hanwha Power, positioning the company across multiple vessel size classes for shipowners transitioning to alternative marine fuels.

Washington – September 19, 2026 -- The Association for Diagnostics & Laboratory Medicine (ADLM) has formally recommended that artificial intelligence tools used in clinical laboratories remain subject to the same validation, quality-system, and monitoring requirements that govern traditional laboratory testing under the Clinical Laboratory Improvement Amendments (CLIA). The recommendation was submitted in a comment letter responding to a federal request for information on potential updates to CLIA, the regulatory framework that has governed U.S. clinical laboratory testing since 1992.

Amsterdam – September 19, 2026 -- OCI N.V. (Euronext: OCI) has published its formal Position Statement in response to a cash takeover offer from NNS Holding (Cyprus) Limited for all issued and outstanding shares in the company, as required under Section 18 of the Dutch Decree on public takeover bids.

NNS formally launched its cash offer on September 19, 2026

NNS announced the launch of the Offer via publication of its offer memorandum, prompting OCI to issue its required Position Statement the following day, September 19, 2026, under Section 18 paragraph 3 of the Besluit openbare biedingen Wft.

Chattanooga, Tenn. – September 19, 2026 -- Tennessee American Water will begin service line material verification work in parts of its Citico Service District the week of September 28, targeting lines currently listed as unknown in company records across Chattanooga, East Ridge, Lookout Mountain, Red Bank and Rossville, GA.

EPA rule requires full lead line replacement by 2037

The verification project supports updated U.S. Environmental Protection Agency rules on lead and copper. Both the U.S. EPA and the Tennessee Department of Environment and Conservation require all water utilities to confirm service line materials, including visual inspection, to build a baseline inventory ahead of the federal mandate to replace all lead service lines by 2037.

Atlanta – September 19, 2026 -- E-cigarette directory laws in Alabama, Oklahoma and Louisiana produced no sustained reduction in flavored e-cigarette sales, according to a study published in JAMA Network Open by researchers from the CDC Foundation. The research, using retail scanner data from January 2021 through April 2025, marks the first rigorous evaluation of how these state registries affect nicotine sales and product availability.

Alabama and Oklahoma directories showed no measurable effect on sales

Researchers found no significant change in per-capita nicotine sales or product availability in Alabama or Oklahoma after directory implementation, using comparison states without such laws as controls.

Albuquerque, N.M. – – September 19, 2026 -- TXNM Energy and Blackstone Infrastructure have filed a motion with the New Mexico Public Regulation Commission (NMPRC) seeking to submit a revised merger application that raises total customer and community benefits to $300 million, more than doubling direct rate credits from the original proposal.

Direct customer rate credits jump to $220 million

The draft revised application increases direct customer rate credits to $220 million, over double the commitment in the initial filing. It also allocates $40 million for workforce and economic development, including job training, scholarships and apprenticeships coordinated with state and local stakeholders.

Hackensack, N.J. -- September 18, 2026 -- Hindsait, Inc. has been approved for the Electronic Prior Authorization category within the CMS Health Tech Ecosystem, placing the clinical AI firm among organizations working with the Centers for Medicare and Medicaid Services to modernize prior authorization ahead of the CMS Interoperability and Prior Authorization Final Rule (CMS-0057-F), which takes effect in 2027.

CMS ecosystem brings payers and providers together on interoperable workflows

The Electronic Prior Authorization initiative unites payers, providers, EHR vendors, and digital health developers to shift prior authorization toward end-to-end interoperable processes before the 2027 deadline.