Regulatory Compliance

San Diego – October 19, 2026 -- Capricor Therapeutics (NASDAQ: CAPR) reported that Duchenne muscular dystrophy patients who switched from placebo to Deramiocel after one year slowed their upper limb decline by 76% compared with their own prior year, according to open-label extension data from the Phase 3 HOPE-3 trial. The U.S. FDA has set a PDUFA target action date of November 22, 2026, for the therapy.

Crossover analysis shows 76% slower decline on PUL 2.0

The late-breaking poster was presented at the 31st Annual Congress of the World Muscle Society in Hiroshima, Japan. It measured upper limb function with the Performance of Upper Limb (PUL 2.0) scale. Of 106 randomized patients, 98 entered the open-label extension, 49 per arm. At Month 24, 42 patients in the placebo-origin arm and 40 in the Deramiocel arm were assessed.

Boston – October 19, 2026 -- TraceLink has set up separate global Commercial, Research & Development (R&D) and Services organizations for each of its two businesses, Track & Trace Compliance and Supply Chain Agentic Business Process (ABP).

Each business line now has its own specialists for product innovation, customer engagement and education, implementation, and ongoing customer success. Both lines continue to run on the OPUS Platform and the Integrate-OnceTM Agentic Business Network.

Track & Trace gets a dedicated Customer Account Management organization

The new account managers will help customers get more from existing investments, improve compliance outcomes, and track changing regulation. TraceLink's multinational compliance roadmap covers emerging requirements in Egypt and Ethiopia and the FDA's move to a uniform 12-digit National Drug Code.

United States – October 19, 2026 -- An energy company with upstream and midstream operations published a Form 4 statement of changes in beneficial ownership of securities on October 19, 2026.

Form 4 filing appears in the company's SEC Filings news section on October 19, 2026

The filing is listed under the SEC Filings category of the company's news page. Form 4 statements report changes in the beneficial ownership of a company's securities.

The posting carries no further detail. It does not name the insider, the transaction type, the number of securities or the transaction value.

The company's website lists operations covering upstream activity, midstream and marketing, and a unit called Next LVL Energy.

Farnborough – October 18, 2026 -- De Havilland Aircraft of Canada has received European Union Aviation Safety Agency (EASA) certification for the Twin Otter Classic 300-G, clearing deliveries to operators across Europe and other regions that recognize EASA approval.

Zimex Aviation flies first EASA-certified Classic 300-G in commercial service

The first EASA-certified aircraft has already been delivered to Switzerland-based Zimex Aviation, which is the launch customer and first operator. The aircraft is in commercial operation.

Zimex is a long-time Twin Otter operator. It uses the aircraft for global operations that include humanitarian aid, government support, cargo transport and special mission flying in remote environments.

United States – October 17, 2026 -- Digital Diagnostics says its LumineticsCore system avoided 91% of unnecessary specialty visits in a pivotal clinical trial and cut time-to-follow-up for positive patients from 60 days to 5 days. The company made the claims in AdvaMed's "The Insight Series: AI & Digital Health," speaking through Jacque Engle, Vice President of Marketing & Communication, and Juli Goldstein, Vice President of Government Affairs & Market Access.

United States – October 17, 2026 -- Three-quarters of medical technology companies surveyed by AdvaMed report memory chip constraints, and 88 percent have seen price increases, as data-center demand squeezes supply of components used in 75 percent to 80 percent of medtech products (excluding personal protective equipment and consumables).

Survey shows allocation limits and procurement uncertainty across medtech

Beyond the 75 percent and 88 percent figures, 63 percent of respondents reported supplier allocation challenges or limited availability of specific components. Another 63 percent are uncertain they can procure enough memory chips, or products containing them, to avoid supply chain disruptions. Fifty-six percent said they are very concerned about overall memory chip supply chain stability.

Boston – October 17, 2026 -- The MedTech Conference, running October 18–21 in Boston, will include 65 early- and mid-stage companies from the 2026 MedTech Innovator cohort, chosen from more than 1,800 applicants, alongside a program that makes digital health a core thread of the event, according to AdvaMed Digital Health Tech's new executive director.

Four policy areas drive the digital health agenda

AdvaMed Digital Health Tech's work spans regulation; payment and health care delivery; data access and stewardship; and cybersecurity. The executive director, whose background at AdvaMed is in coverage, payment and care delivery policy, said progress in each area depends on the other three.

Payment is a particular focus. AdvaMed is advocating for greater clarity and predictability around Medicare coverage and payment for software, AI and other digital health technologies.

Boston – October 17, 2026 -- AdvaMed's The MedTech Conference, set for October 18–21, 2026, will host its largest Medtech Campus to date, with 185+ presenting companies and more than 500 speakers across Campus and education sessions. The trade body reports member participation at an all-time high and says nearly half of registered attendees are new to the event.

Keynote stage pairs device CEOs with a Wall Street analyst

Mick Farrell of Resmed, Mike Mahoney of Boston Scientific, Ashley McEvoy of Insulet and Robbie Marcus of J.P. Morgan will join a discussion moderated by John Babitt of EY. Johnson & Johnson MedTech and Operation Smile will add further perspectives.

United States – October 17, 2026 -- AdvaMed has told the U.S. Copyright Office that software built to diagnose, configure and service a medical device is a distinct product and should not be treated like the software that operates the device.

AdvaMed separates clinician-facing software from servicing tools

The trade group's comments contrast two categories. One is software clinicians use to operate an imaging system. The other is software designed specifically to diagnose, configure and service that system. AdvaMed compares the split to a vehicle's operating software versus the specialized diagnostic tools technicians use to repair it. In its framing, one enables use of the product, while the other is a standalone tool with its own functions, users, protections and market.

Selangor – October 17, 2026 -- Founder Group Limited (FGL) will combine its shares at a ratio of 100 for 1 effective September 1, 2026, shrinking its Class A share count from 7,369,159 to approximately 73,693 as it works to regain compliance with Nasdaq Marketplace Rule 5550(a)(2).

Class A shares move to a new CUSIP on September 1

Class A shares will trade on the Nasdaq Capital Market on an adjusted basis from the opening of trading on September 1, 2026. The ticker stays "FGL", but the shares carry a new CUSIP number, G3662E147. The company said the aim is to maintain its Nasdaq listing.

Class B count falls from 186,358 to about 1,865

Immediately before the combination, 7,369,159 Class A shares and 186,358 Class B shares, both of no par value, are issued and outstanding. Afterwards, Class A shares will total approximately 73,693 and Class B shares approximately 1,865.