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CraniUS Therapeutics Receives FDA 510(k) Clearance for the CraniUS® Plate, a Patient-Specific Cranial Implant

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Clearance establishes the company’s first product for the U.S. market and the foundation of its investigational NeuroPASS™ platform.

BALTIMORE, Sept. 9, 2026 /PRNewswire/ — CraniUS Therapeutics today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the CraniUS Plate, a patient-specific cranioplasty implant intended for the repair of cranial defects. The clearance permits CraniUS Therapeutics to market the CraniUS Plate in the United States — the company’s first commercially available product.

The CraniUS Plate is designated NeuroPASS 1 and is the foundational configuration of the company’s NeuroPASS platform.

“This clearance is an inflection point for the company and a defining milestone for the people who did the work to get here,” said Michael Maglin, Chief Executive Officer of CraniUS Therapeutics. “It moves us from development to a cleared product we can put in surgeons’ hands.”

The FDA issued its substantial equivalence determination on July 29, 2026, under submission number K261058. The CraniUS Plate is regulated as a Class II preformed alterable cranioplasty plate under 21 CFR 882.5320 (product code GWO), and the submission was reviewed by the Division of Neurosurgical, Neurointerventional, and Neurodiagnostic Devices within FDA’s Center for Devices and Radiological Health.

Each CraniUS Plate is designed and manufactured to match the individual patient’s anatomy, giving neurosurgeons and craniofacial surgeons a patient-specific option for reconstructing cranial defects resulting from trauma, tumor resection, decompressive craniectomy, and other causes.

That anatomy, the company believes, holds untapped potential.

“Cranial reconstruction has been treated as a purely structural problem for decades, when the space beneath the plate is some of the most valuable real estate in the body,” said Dr. Chad Gordon, Founder, Executive Chairman and Chief Medical Officer of CraniUS Therapeutics. “A cleared, patient-specific plate is the foundation of our long-term vision for what a cranial implant could one day do for patients.”

NeuroPASS™ 1: The Foundation of a Configurable Cranial Implant Platform

The cleared CraniUS Plate, designated NeuroPASS 1, establishes the structural and manufacturing foundation of the NeuroPASS platform. The platform is built on a patient-specific implant architecture that CraniUS is developing to support additional features for brain access, diagnostics, and drug delivery, subject to applicable regulatory requirements.

Programs in development include durable access to the brain, integrated sensing and diagnostics, and a fully implantable system designed for long-term targeted delivery of therapeutics from within the cranial space, with the goal of bypassing the blood-brain barrier. These programs are investigational and are not part of the cleared device.

“NeuroPASS 1 is the foundation of the platform we set out to build,” said Mark Wladkowski, Chief Operating Officer and Chief Technology Officer of CraniUS Therapeutics. “It gives surgeons a patient-specific implant today, and it gives our team a cleared, manufacturable base that the rest of the platform is designed to build on. The architecture is configurable by intent, so brain access, diagnostics, and drug delivery can be added to the same base as each of those programs matures and is authorized on its own.”

The CraniUS Plate is cleared only for the repair of cranial defects, consistent with its FDA-cleared indications for use.

About CraniUS Therapeutics

CraniUS Therapeutics is a Baltimore-based neurotechnology company founded in 2021. The company’s cleared CraniUS® Plate, designated NeuroPASS 1, provides patient-specific cranial reconstruction and serves as the foundation of the company’s investigational NeuroPASS™ platform.

The NeuroPASS platform is a configurable implant architecture being developed to add durable access to the brain, integrated sensing and diagnostics, and fully implantable systems designed to bypass the blood-brain barrier through long-term, targeted drug delivery from within the cranial space. These investigational programs are being developed with the aim of addressing debilitating neurological conditions across multiple disease types.

CraniUS Therapeutics collaborates with clinical and research partners globally.

Forward-Looking Statements

This press release contains forward-looking statements, including statements regarding the development of the NeuroPASS platform, its planned capabilities for brain access, diagnostics, and drug delivery, and future products. Such statements reflect current plans and expectations, involve risks and uncertainties, and are not guarantees of future performance or regulatory outcomes.

Investigational products and programs described in this release have not been cleared or approved by the FDA, and no claim is made regarding their safety or effectiveness. There is no assurance that any product or program in development will be completed, will perform as intended, or will receive regulatory authorization.

Media Contact

Elizabeth A. Dale | External Relations
edale@craniusmed.com | https://craniustherapeutics.com

 

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SOURCE CraniUS Therapeutics

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LeoLabs Teams with SciTec to Support U.S. Space Force Ground-Based Radar Digitization Program

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MENLO PARK, Calif., Sept. 9, 2026 /PRNewswire/ — LeoLabs, Inc. (LeoLabs), the leading provider of persistent Orbital Intelligence, today announced it is teaming with SciTec, a Firefly Aerospace company, to support its recently awarded $93,704,410 firm-fixed price other transaction agreement for ground-based radar digitization. This contract provides for modernization efforts to create a common architecture and design for the upgrade of ground-based radars. Space Systems Command, Colorado Springs, Colorado, is the contracting activity.

“Today’s threat environment demands more resilient sensing capabilities that can be scaled and fielded at the pace of the mission,” said Tony Frazier, Chief Executive Officer of LeoLabs. “We’re proud to bring our proven radar technology and operational expertise to this modernization initiative, helping deliver the speed, scale, and resilience needed to meet the U.S. Space Force’s evolving mission requirements.”

About LeoLabs

LeoLabs enables military space commands, civil government agencies, and commercial operators to confidently detect, track, characterize, and respond to threats in space. Our proliferated, multi-mission radar network, real-time orbital data catalog, and AI-powered analytics support secure, safe, and dynamic space operations.

View original content to download multimedia:https://www.prnewswire.com/news-releases/leolabs-teams-with-scitec-to-support-us-space-force-ground-based-radar-digitization-program-302872945.html

SOURCE LeoLabs, Inc.

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ZEEKR Shooting Brake Retains Global Sales Crown: August Deliveries Surpass 10,000 Again, Cumulative Total Exceeds 400,000

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HANGZHOU, China, Sept. 9, 2026 /PRNewswire/ — ZEEKR’s shooting brake lineup has delivered another standout performance. Global deliveries in August once again surpassed 10,000 units, marking the third consecutive month of five-figure monthly deliveries. To date, cumulative global sales of ZEEKR shooting brakes have exceeded 400,000 units, capturing approximately 70% of the global shooting brake market and firmly securing the brand’s position as the global sales leader in the segment.

According to the data, in the first half of 2026, the ZEEKR 007GT topped the shooting brake sales chart with 26,738 units delivered. Combined sales of ZEEKR’s shooting brake models exceeded 42,000 units — far surpassing the combined total of all other brands in the segment. Meanwhile, ZEEKR shooting brakes have fully entered the European market and are steadily establishing a foothold in multiple international premium EV markets, demonstrating strong global competitiveness.

Amid an automotive market mired in homogenization and intense competition, ZEEKR shooting brakes stand out through original design that builds instant visual recognition, and through full-stack 900V high-voltage architecture and other technologies that create a formidable product moat. With its product philosophy of “shooting brake means all-around capability,” ZEEKR is breaking the homogenization trap in the new energy vehicle market — while setting a new benchmark for success in the global premium EV segment.

View original content:https://www.prnewswire.co.uk/news-releases/zeekr-shooting-brake-retains-global-sales-crown-august-deliveries-surpass-10-000-again-cumulative-total-exceeds-400-000–302873803.html

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Parlance Brings Verified Push Notification Security to Health System IT Help Desks on ServiceNow Store

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WOBURN, Mass., Sept. 9, 2026 /PRNewswire/ — Parlance, a healthcare voice AI company, today announced the availability of its help desk intelligent virtual assistant (IVA) on the ServiceNow Store, alongside a new capability built specifically for the voice channel: Cisco Duo-verified push notification identity verification for sensitive IT requests.

Password resets drive up to half of IT help desk calls. The Parlance help desk IVA now verifies each caller on the spot — a one-time code read aloud on the call, confirmed in an enterprise-level authenticator app — securing the voice channel’s toughest identity verification requirements.

For health system IT leaders, the problem is not abstract. Password resets are commonly estimated to drive 20–50% of IT help desk call volume, and each ticket carries significant cost. Recent industry analyses put the fully loaded price of a single agent-handled password reset — labor, hold time, lost productivity — anywhere from $25 to $70. At a health system fielding thousands of calls a month, that’s a meaningful line item in the IT budget.

The burden on human IT staff is pervasive across industries, not just healthcare. “The majority of IT call volume is password related,” said Bindu Madhavi, Senior Director of Global ServiceNow DevOps and Contact Center at Securitas Security Services USA, Inc. “Many of my colleagues report the number to be nearly 70%.”

Purpose-built for healthcare IT

Traditional IVR systems weren’t built for the complexity of modern IT workflows, and most AI voice solutions weren’t built with the identity verification infrastructure to handle anything sensitive at the voice channel. Parlance help desk IVA was built to close both gaps at once, combining an agentic, AI-native conversational layer (so the interaction sounds like a natural back-and-forth rather than a scripted menu), with enterprise-grade identity verification that meets the security expectations of a regulated industry.

Verified push notification: the security differentiator

What sets this ServiceNow Store listing apart is not automation on its own. What makes this different is the security capability underneath it — what happens when a caller requests something sensitive. Alongside the ServiceNow Store launch, Parlance announces the availability of push-notification-based identity verification within the help desk IVA, built on a new MSP partnership with Cisco Duo.

Approval requires more than a tap. When a caller requests a password reset, the agentic AI system reads aloud a pin, then sends a verified push notification to the caller’s registered device: the caller confirms the spoken PIN inside the enterprise-level authenticator app on their phone, not a simple tap-to-approve. That distinction in the Parlance help desk IVA — a verified push versus a standard one — is what separates a safely routed call from an exploitable one, and it addresses a security requirement the voice channel has largely lacked. Tying the approval to that specific live call and that specific request is a meaningfully stronger standard than an unverified push notification or an SMS-delivered PIN, neither of which confirms that the person approving is actually the person on the line.

Product capabilities

The Parlance help desk IVA supports a growing library of self-service workflows, including:

Password reset — verified via Duo push notification (or another supported authenticator app), with a secure reset link delivered by SMS

Intelligent routing — callers are routed to the right queue or agent based on intent and proper name recognition, with full call context pre-populated on the agent desktop

Ticket status — callers receive real-time ServiceNow ticket status by voice, without agent involvement

Answers to FAQs (frequently asked questions) — the IVA answers common IT questions directly from the ServiceNow knowledge base

Parlance is already deployed at major health systems, including a $4 billion healthcare organization in the western United States. There, employees resolve password resets and other routine IT requests by voice, without waiting on hold for a live agent, freeing up time for the employee making the request and the IT staff who would otherwise be fielding it. 

“The help desk IVA on the ServiceNow Store represents a new chapter for Parlance. We’ve taken the conversational AI platform we’ve built for the healthcare patient access contact center, one that’s processed millions of calls at major health systems, and applied it to the IT help desk, where the same problems exist: high call volumes, repetitive requests, and frustrated employees waiting on hold. The addition of Cisco Duo-powered push notification verification means we’re not just automating the easy calls, we’re handling the sensitive ones too, with the security and compliance posture that healthcare IT teams require,” said Sanjay Yadav, Head of Engineering at Parlance.

“The ServiceNow Store launch opens a significant new market for Parlance in healthcare IT. IT service management is one of the largest and fastest-growing segments for AI voice automation, and the help desk IVA gives health systems a differentiated, production-ready offering they can deploy with confidence,” said Scott D’Entremont, CEO of Parlance.

For CIOs and CTOs deciding where to modernize next, the voice channel has been the hardest one to secure, and the easiest one to overlook, despite quick ROI. Built on an agentic AI architecture, the Parlance help desk IVA is designed to close that gap.

About Parlance

Parlance is a healthcare voice AI company that intelligently routes hospital and clinic calls, resolves routine requests, and reduces the burden on staff answering phones, without adding headcount. Parlance has production deployments at 400+ major health systems, including HCA Healthcare, Providence Health, UC San Diego Health, Keck Medicine of USC, NYU Langone Health, Banner Health, Baptist Health, and thousands of hospitals and clinics nationwide. Parlance brings AI-native voice intelligence, deep system integrations, and proprietary proper name recognition technology to healthcare IT and patient access. For more than 30 years, health systems, enterprise organizations, and higher education institutions have relied on the Parlance platform. Parlance is headquartered in Woburn, Massachusetts. Learn more at parlancecorp.com.

Media Contact

Alexandra Karasic
Head of Marketing, Parlance
888-700-6263  |   akarasic@parlancecorp.com  |  www.parlancecorp.com

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SOURCE Parlance

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