Labor Day is next Monday in the U.S.; this is the last full week of Q3 for many of you.
Last week was a lesson in dependencies. A single intrusion stopped one of the world's largest device makers from shipping product. A single component inside a heart-pump controller is now tied to three deaths. A single patent judgment attached a 6% royalty to eleven of a liquid-biopsy company’s products for the next seven years. An activist told a heart-failure implant maker that going it alone is the risk. And the administration is reportedly adding two deputy commissioners at the FDA — one of them for AI — to tighten its grip on the agency. The companies that had the better week were the ones that removed a dependency: Abbott got the first sensor that watches ketones so patients don’t have to, and Roche got a blood test that can stand in for a PET scan. Know what you’re leaning on. Know who controls it.
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8 things to watch this week:
1. 🔒 Boston Scientific’s ordering and shipping disrupted in cyberattack
Boston Scientific disclosed a cyberattack that has affected its ability to process and ship customer orders, describing a global disruption to operations in an SEC filing; the company identified the attack on Tuesday and has not said how long the disruption will last. Employees at its Cork, Ireland manufacturing facilities were sent home because they couldn’t work, and by Saturday the company said the unauthorized activity appeared limited to certain on-premise systems, with no impact to cloud-based systems, and that it is working with CrowdStrike. Stifel analysts flagged increased uncertainty around the company’s 2026 revenue, margin and EPS outlook. This is the fourth major medtech intrusion of 2026 after Stryker, Intuitive and Medtronic — and the first where the headline damage is a stopped shipping dock rather than stolen data. If your hospital customers are asking about your business-continuity plan this week, that’s why.
MedTech Dive
2. 🧭 Most device companies don’t fail on technology. They fail on sequencing.
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3. ❤️🩹 FDA flags recall of all Impella heart-pump controllers after three deaths
The FDA issued an early alert after Abiomed told customers to remove all Automated Impella Controllers from where they’re used or sold due to purge cassette recognition failures; as of August 17 the company had reported 37 serious injuries and three deaths. J&J says the issue appears in 0.2% of cases, that hospital inventory can keep being used to maintain continuity of care while replacements are scheduled, and that it will swap the purge flag and purge retainer components during annual preventive maintenance or through field-service outreach. Controller issues were tied to recalls in July, September, October (twice) and December 2025 and again in May, which means the company’s most important acquisition since 2022 has now spent more than a year in near-continuous field action. Watch how the language shifts from “correction” to “remove all.”
Cardiovascular Business
4. 🩸 Abbott wins FDA nod for the world’s first dual glucose-ketone sensor
Abbott received De Novo authorization for Libre Duo 10 Day, a dual-analyte sensor that continuously measures glucose and ketones, wearable for 10 days by people with diabetes ages two and up who take insulin or other glucose-lowering medications; it received CE mark in May. The company says it’s the first system to meet both the FDA’s iCGM standard and a new integrated continuous ketone monitoring standard, which establishes a benchmark for continuous ketone monitoring in the U.S. — in other words, Abbott didn’t just win a clearance, it helped write the special controls every follower will now have to meet. Integration with Beta Bionics’ iLet and Sequel’s twiist is expected by year-end, with Insulet and Tandem in 2027; William Blair expects the sensor to be most competitive in pediatrics once it’s pump-integrated, since Dexcom’s approved pediatric sensors are also 10-day. Abbott receives FDA nod for dual-analyte sensor | MedTech Dive +3
MD+DI
5. 🧠 FDA clears Roche’s Alzheimer’s blood test for rule-in and rule-out assessment
Roche’s Elecsys pTau217 plasma test is cleared for people 55 and older with signs of cognitive decline, used alongside clinical information to assess Alzheimer’s risk. Developed with Eli Lilly, it’s the first FDA-cleared single-biomarker blood test supporting both rule-in and rule-out assessment of amyloid pathology using the same cutoffs across primary and specialty care, and it runs on existing lab instrumentation without new hardware. Labcorp and Quest both plan to offer it. The strategic read: a test that can rule out in primary care changes who gets referred for PET and CSF workups — and who doesn’t — which matters to anyone selling into the anti-amyloid infusion channel.
MassDevice
6. ⚖️ Guardant ordered to pay $245M in DNA-sequencing patent dispute
A U.S. district court entered final judgment ordering Guardant Health to pay more than $245.2 million to TwinStrand Biosciences and the University of Washington, upholding a November 2023 jury verdict that Guardant willfully infringed two Duplex Sequencing patents; Guardant must also pay a 6% ongoing royalty on 11 products and services through patent expiry in March 2033. The covered products include Guardant360, Guardant Reveal and Guardant Shield, though Guardant says it will appeal, that updated versions of Reveal and Shield are excluded from the royalty order, and that it continues to challenge the patents at the USPTO. Execution of the judgment and royalty collection are stayed pending appeal. Six points of gross on your flagship products for seven years is a licensing negotiation you’d rather have had in 2019.
Medical Device Network
7. 📣 CVRx has an activist investor urging it to get acquired
Pointillist Family Office founder Jorey Chernett, who holds 5.5% of CVRx, publicly told the Barostim maker’s board it should sell to a large device company with an established heart-failure and EP sales force, national payer relationships to resolve the prior-authorization impasse, and a balance sheet to fund the pivotal work already underway — citing a second-quarter report in which the company cut revenue guidance and disclosed a DOJ civil investigation into sales and marketing practices. Shares had lost a third of their value in a month before the letter; the board says it’s open to constructive engagement, and Johnson & Johnson already owns 15.2%. The argument isn’t that the device doesn’t work — it’s that reimbursement, sales coverage and trial funding are a scale problem a $3 stock can’t solve alone. Expect that thesis to get applied to other single-product neuromod names.
MassDevice
8. 🏛️ HHS plans new FDA deputy commissioner roles for technology and drugs
HHS is planning to appoint two new deputy commissioners at the FDA — one for technology, including health and AI, and one for drugs — in what some in the administration view as a bid to exert greater influence over the agency; no final decisions or announcements have been made. Jared Seehafer, an FDA senior advisor and device-industry veteran who co-founded the compliance software company Enzyme, is the leading candidate for the technology role, which would oversee both the agency’s internal use of AI and its review of AI-enabled products. Both roles would report to commissioner nominee Heidi Overton, who still needs Senate confirmation. Put this next to the generative-AI discussion paper from two weeks ago: the docket closes October 19, and the person who may end up owning the answer is a device-software founder.
CNBC
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