Jim Talbot

Kestra Medical Technologies Reports First Quarter Fiscal 2026 Financial Results KIRKLAND, Wash., Sept. 11, 2025 (GLOBE NEWSWIRE) -- Kestra Medical Technologies, Ltd. (Nasdaq: KMTS), a wearable medical device and digital healthcare company, today reported financial results for the first quarter fiscal 2026, which ended July 31, 2025. Financial Highlights Generated revenue of $19.4 million in Q1 FY26, an increase of 52% compared to the prior year period. Expanded gross margin to 45.7% in Q1 FY26 compared to 32.9% in the prior year period. Increased FY26 revenue guidance to $88 million, representing growth of 47% compared to FY25. “We had a strong start to fiscal 2026, with our sustained commercial momentum generating revenue growth of over 50% in the first quarter,” said Brian Webster, President and CEO. “We also continued to make progress on several key operational objectives, including growing the commercial organization, enhancing our revenue cycle management capabilities, and expanding gross margin. As we progress on our journey to category leadership, we remain focused on both market share capture and growing the wearable defibrillator market, while executing on our commitments to patients and their prescribers.” First Quarter Fiscal 2026 Financial Results Total revenue was $19.4 million, an increase of 52% compared to the prior year period. 4,205 prescriptions were written for the ASSURE® system, an increase of 51% compared to the prior year period. Revenue growth was driven by higher market share with existing customers and activation of new accounts. Revenue also benefited from a higher mix of in-network patients and improvements in revenue cycle management capabilities. Gross profit was $8.9 million compared to $4.2 million in the prior year period. Gross margin expanded to 45.7% compared to 32.9% in the prior year period, driven by volume leverage and a higher mix of in-network patients. GAAP operating expenses were $37.7 million and included $2.9 million of non-recurring new public company costs. GAAP operating expenses were $22.6 million in the prior year period. Excluding non-recurring new public company costs and share-based compensation expense, operating expenses were $30.3 million in Q1 FY26. The increase was attributable to growth in expenses related to commercial and revenue cycle resources. GAAP net loss and comprehensive loss was $25.8 million compared to GAAP net loss and comprehensive loss of $20.3 million in the prior year period. Adjusted EBITDA* loss was $19.4 million compared to an adjusted EBITDA loss of $15.7 million in the prior year period. Cash and cash equivalents totaled $201.2 million as of July 31, 2025. Fiscal Year 2026 Revenue Guidance Kestra is increasing its FY26 revenue guidance to $88 million, representing growth of 47% compared to FY25. This compares to prior FY26 revenue guidance of $85 million.

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For years, one of the biggest fears for companies exporting to the U.S. was ending up on an FDA import alert list — a signal of compliance problems that blocked their products at the border. But as of September 5, the narrative has shifted. For manufacturers of GLP-1 products outside the U.S., being on this specific list has become a badge of honor. Why? Because this green list now represents a positive status: it means the FDA has inspected the facility and found no GMP violations, effectively granting approval to export into the U.S. market.

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White Paper Wednesday: Medical Device Design and Development Guide Bringing a medical device to market is complex, but your roadmap doesn't have to be. 🎯 Start with a clear intended use and proper FDA device classification 🧩 Build a solid QMS early to streamline compliance 👥 Use real user feedback to shape meaningful design inputs 🔄 Verify, validate, and iterate to ensure a safe, effective final device Click the link to read this week's product development white paper 👉 https://lnkd.in/e2pX73c8 #Synectic #ProductDevelopment #Innovation #WhitePaper #MedicalDevices #MedicalDeviceDesign #FDA #Engineering #HealthcareDesign

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Today, FDA published its weekly list of recent Warning Letters. This Warning Letter to ASP Global only cited one QMS area - purchasing controls, while also citing violations related to the MDR regulation, Corrections and Removals regulation, and a failure to get clearance before marketing a significantly changed device. This one statement in sub-section C of citation 1 (Purchasing Controls) struck me as particularly interesting: "C. (b)(4) [the supplier] was audited by FDA in (b)(4) and received four observations, but ASP Global was not notified until April 29, 2025, after (b)(4) was placed on Import Alert, despite working closely with (b)(4) on SCAR-339 from February to March 2025. The ASP/(b)(4) Quality Agreement, Section 2.3, Page 6 of 15, states "(b)(4) shall notify ASP in writing within (b)(4) if any of the following occurs: (c) (b)(4) becomes aware of any inspection or audit findings that affect safety, effectiveness, conformity, or availability of product."" Effectively, ASP Global was cited in the Warning Letter because its supplier failed to notify it of the outcome of an FDA inspection (i.e., import alert) despite a requirement to provide such notification in the Supplier Quality Agreement (SQA). Initially, it seems unfair that FDA would cite a firm for something its supplier failed to do, but it speaks to a very important need within supplier quality teams at medical device manufacturers. SQAs cannot be once-and-done documents. The ongoing monitoring of suppliers (21 CFR 820.50 and ISO 13485:2016, clauses 4.1.5, 7.4.2) must include ensuring that the supplier is meeting all of its obligations under the SQA. As we see from this WL, FDA may hold you accountable for a supplier not complying with an SQA if they feel you haven't done your job in enforcing its provisions. https://lnkd.in/gsQ-cyjZ

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Many startups treat QMS as something you install before inspection. Regulators see it as proof that your success wasn’t accidental. A QMS isn’t about paperwork — it’s about demonstrating repeatability, control, and accountability as complexity grows. This section reframes QMS as an operating backbone: 🎾 Why results without systems aren’t trusted 🎾 What “minimum viable QMS” really means for startups 🎾 How QMS supports evidence integrity and submissions 🎾 Design controls as strategic protection, not overhead 🎾 Common shortcuts that fail under audit 🎾 When to scale QMS sophistication and when not to If your QMS lives in a binder, your approval is living on borrowed time. https://lnkd.in/gHhJB5VG #RegulatoryStrategy #DiagnosticRegulation #IVDRegulatory #IntendedUse #ClaimsArchitecture #AnalyticalValidation #ClinicalValidation #IRB #IDE #FDA_PreSub #RegulatoryExecution #QMS #ChangeControl #PostMarketSurveillance #RegulatoryReadiness

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Free download alert: Navigating FDA Cybersecurity Requirements for Medical Devices 🩺 Medical device manufacturers face new pressure from the U.S. Food & Drug Administration to embed cybersecurity into device design, risk management, and post-market monitoring. Our latest whitepaper breaks down the requirements, compliance risks, and real-world tactics to stay ahead. Dive into: - Key FDA cybersecurity expectations and timelines - How to integrate controls into your medical device lifecycle - A practical framework that maps device security to regulatory risk Download link in comments ⬇️ #MedTech #Cybersecurity #FDA

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Despite everything, Israeli startups deliver. In the midst of the recent Iranian attack and national emergency, we reached a critical milestone at Avertto.  Our final EMC testing — part of the regulatory process before FDA registration of AMIT301 — was scheduled at Hermon Laboratories. Thankfully, as an essential facility supporting both civilian and military systems, they remained operational. Our CTO, Yaniv Kirma, managed to reach the lab during this challenging time. Thanks to the excellent work of meron ben pazi and Igor Gindin, we completed the EMC testing, with Yair Lavi backing up the algorithms. Meanwhile, Kety Bardugo, currently stranded abroad due to the closure of Israeli airspace, began preparing our FDA Class I registration remotely with Katya Serebreny, retrieving our UDIs from GS1. Even logistics became a small national operation: equipment boxes had to be transferred from I2D for testing and shipping preparations. With the help of a security guard and some creative coordination, they were safely moved and are now ready for shipment and shelf-life testing. In parallel, our 14-day ARC reliability test continues to run at our office in PowerBall- OFFICES FOR THE BEST. With travel restrictions and Home Front Command limitations preventing access to the office, Guy Karpel and Michael, the dedicated cleaner, who had to enter the facility, kindly sent us a video confirming the system is up and running exactly as planned. None of this would have been possible without the incredible commitment of the Israeli ecosystem — Hermon Laboratories, Powerball, i2D, GS1 Israel for UDI support, and our dedicated team. Registering AMIT301 as an FDA Class I medical device is a major milestone for Avertto. And yes — we are now raising our Seed round, even in these historic times. Because innovation doesn't stop — especially when the mission is saving lives. #LionsRoar #IsraeliInnovation #MedTech #HealthTech #Startups #MedicalDevice #FDA #HealthTech #Avertto

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Can the FDA replace the FDCA 360kk with an ISO standard? AI says Short answer: No — the FDA cannot simply “use an ISO standard” in place of the statutory requirements of 21 U.S.C. § 360kk. ISO standards may inform or be incorporated into FDA regulations, but they cannot substitute for obligations created by the Federal Food, Drug, and Cosmetic Act (FDCA). house.gov --- 🧭 Why ISO Standards Cannot Replace FDCA § 360kk 📌 1. FDCA § 360kk is a statutory mandate 21 U.S.C. § 360kk requires the Secretary (delegated to FDA) to prescribe performance standards for electronic products to control radiation emissions. These standards must be issued by regulation, not by reference to a private standard alone. house.gov 📌 2. ISO standards have no legal force unless FDA incorporates them ISO standards are voluntary, private, international consensus documents. They become legally binding only if FDA formally incorporates them into its regulations under Title 21 CFR Subchapter J. FDA does this occasionally, but only through rulemaking. 📌 3. FDA may reference or harmonize with ISO standards FDA often aligns with ISO standards in areas like: • Quality systems (e.g., ISO 13485) • Risk management (ISO 14971) • Radiation safety testing methods But alignment ≠ substitution. The agency must still enforce the statutory requirements of § 360kk. 📌 4. FDA’s radiation control regulations are specific and mandatory FDA’s electronic product radiation control rules (21 CFR §§ 1000–1050) implement § 360kk and include: • Certification requirements • Labeling • Reporting • Performance standards for specific product types Food and Dru... These cannot be replaced by ISO documents. --- 🧩 When ISO Standards Can Be Used ISO standards may be used by manufacturers to: • Demonstrate conformity with certain FDA expectations • Support premarket submissions • Provide test methods or engineering practices But FDA still evaluates compliance against the FDCA and its own regulations, not ISO alone. --- 🏁 Bottom Line ISO standards can supplement, support, or be incorporated into FDA regulations — but they cannot replace statutory requirements like FDCA § 360kk. The FDA must follow the law, and only Congress can change that law. If you want, I can also explain: • How FDA incorporates ISO standards into regulations • Whether a specific ISO standard is relevant to § 360kk • How manufacturers can use ISO standards in compliance strategies

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