Regulatory Compliance

Aubonne – September 17, 2026 -- Intuitive has secured CE mark approval for its da Vinci SP surgical system to perform transvaginal gynecologic procedures, marking the first such indication for the Single Port platform anywhere in the world.

Approval widens da Vinci SP's European surgical scope beyond five existing categories

The new indication adds to da Vinci SP's current CE-marked applications in Europe, which cover endoscopic abdominopelvic, thoracoscopic, transoral otolaryngology, transanal colorectal, and breast procedures. The system now supports natural orifice surgery across transoral, transanal, and transvaginal routes.

San Francisco – September 17, 2026 -- The Agentic AI Foundation (AAIF) has launched the Model Context Protocol Associate (MCPA), the first official certification validating engineers' understanding of the Model Context Protocol (MCP), as monthly downloads of MCP's Tier 1 SDKs approach half a billion.

MCP usage has surged to nearly half a billion monthly downloads

Both the TypeScript and Python SDKs for MCP have each surpassed 1 billion total downloads. MCP tool calls from ChatGPT users reached 98 times their January level by August 2026, while email API provider Resend passed one million MCP calls in a single month.

Suzhou – – September 17, 2026 -- Accro Bioscience said AC-101 tablets have been included in the National Medical Products Administration's Center for Drug Evaluation (CDE) "Caring Plan-Extension" pilot program, targeting Blau syndrome as the proposed indication, with the public notice period closing September 17, 2026.

NMPA pilot program aims to accelerate rare disease drug development in China

The Caring Plan-Extension pilot, run by China's CDE, is designed to encourage innovative drug development for rare diseases. Accro Bioscience confirmed the inclusion took effect September 17, 2026, China Standard Time (UTC+8).

FDA granted AC-101 Rare Pediatric Disease designation three months earlier

The U.S. Food and Drug Administration awarded AC-101 Rare Pediatric Disease (RPD) designation for Blau syndrome in June 2026, ahead of the Chinese regulatory step.

Hong Kong – September 17, 2026 -- Akeso, Inc. (9926.HK) reported that its bispecific antibody ivonescimab reduced the risk of death by 27% compared with Merck's pembrolizumab in a Phase III trial of PD-L1-positive non-small cell lung cancer (NSCLC), with results presented as a Late-Breaking Abstract at the 2026 World Conference on Lung Cancer (WCLC).

Ivonescimab extends median survival to 30.8 months in head-to-head trial

In the intention-to-treat population of the HARMONi-2 study (AK112-303), patients treated with ivonescimab monotherapy achieved a median overall survival (OS) of 30.8 months versus 22.6 months for pembrolizumab (HR=0.73; 95% CI: 0.57–0.95; P=0.009). The data cutoff was September 17, 2026, with a median follow-up of 36 months and 234 OS events recorded. Professor Caicun Zhou, principal investigator and IASLC President, is scheduled to deliver the full oral presentation on September 15.

Yiwu, China – September 17, 2026 -- CrossBoundary Energy's (CBE) 233 MW Kamoa solar project in the Democratic Republic of the Congo has reached full-capacity grid connection and commercial operation, just 16 months after the power purchase agreement was signed.

Kamoa becomes Africa's first solar-plus-storage project to deliver round-the-clock baseload power

The project sits adjacent to the Kamoa-Kakula Copper Complex, one of the world's largest copper mining operations, replacing the diesel generation that remote African mines have historically relied on for continuous production.

Seoul – September 17, 2026 -- SystImmune, Inc. announced that new global Phase 1 data support 2.5 mg/kg D1D8 Q3W as the recommended Phase 3 dose for iza-bren (izalontamab brengitecan), a bispecific EGFRxHER3 antibody drug conjugate, in previously treated EGFR-mutated metastatic non-small cell lung cancer (NSCLC).

Randomized Phase 1 cohort confirms higher efficacy at the 2.5 mg/kg dose level

The abstract, presented in an oral session at the IASLC 2026 World Conference on Lung Cancer (WCLC) in Seoul, South Korea, evaluated iza-bren across three dose levels in a randomized dose-expansion cohort. Patients enrolled had EGFR-mutated metastatic NSCLC and had previously received a third-generation EGFR inhibitor. Results showed promising antitumor activity with a manageable safety profile, with the highest efficacy observed at the 2.5 mg/kg dose.

Boston – September 17, 2026 -- PerZeption Inc. has secured a Phase I Small Business Innovation Research (SBIR) grant from the National Eye Institute to fund development of a new photostress recovery test for age-related macular degeneration (AMD), a condition affecting an estimated 20 million people in the United States.

NEI Funds Photostress Recovery Test for Earlier AMD Detection

The award backs the project "Efficient Achromatic and Chromatic Photostress Recovery Assessment for Age-related Macular Degeneration," which will be carried out in collaboration with researchers at the Brunson Center for Translational Vision Research at the University of California, Irvine. The work targets how quickly vision recovers after bright-light exposure, a marker of macular health that can reveal functional deficits before they show up on standard acuity tests.

Wilmington, Del. – September 17, 2026 -- The U.S. Bankruptcy Court has disqualified law firm HSF Kramer from representing Pleasants Power Station in its Chapter 11 proceedings, sustaining conflict-of-interest objections raised by Omnis Fuel Technologies and the Office of the United States Trustee.

Los Angeles – September 17, 2026 -- Adventist Health White Memorial and Adventist Health White Memorial Montebello generate more than $1.2 billion in annual economic activity and support approximately 5,500 jobs across Los Angeles County, according to a new study.

Study quantifies hospitals' role as economic anchors serving 2.4 million residents

The analysis, conducted by the Los Angeles County Economic Development Corporation (LAEDC), examined the two hospitals' functions as healthcare providers, employers, and community anchors. Combined, they serve more than 2.4 million residents across their primary and secondary service areas.

Quebec – September 17, 2026 -- Devonian Health Group Inc. (TSXV: GSD) (OTCQB: DVHGF) expects its common shares and warrants to begin trading on NYSE American LLC as early as September 17, 2026, under the ticker symbols "DHGR" and "DHGR WS."

Devonian pursues dual listing tied to underwritten public offering

The proposed NYSE American listing is connected to an underwritten public offering of Devonian's common shares and warrants. The company will retain its existing listing on the TSX Venture Exchange and has reserved the symbol "DHGR" there, with plans to later change its TSXV ticker from "GSD" to "DHGR."

Listing remains contingent on NYSE American's final authorization

Trading commencement on NYSE American depends on market conditions and final approval of Devonian's listing application, as well as the company's continued compliance with exchange rules.