Monday May 18, 2026
The week's biggest signal: leadership is up for grabs — in Washington and across the C-suite. FDA Commissioner Marty Makary resigned mid-week, activist investor Elliott landed another medtech scalp at Dexcom, Carl Zeiss telegraphed deep restructuring, and a federal trade court called the administration's blanket 10% tariff illegal. Beneath the turbulence, the operating cadence continued: another AI device clearance, a fresh IVL launch from J&J, and a Stryker deal closing in the same space.
8 things to watch this week:
1. ⚖️ Makary out at FDA after 13 tumultuous months
Marty Makary resigned as commissioner of the Food and Drug Administration Tuesday, ending a 13-month tenure marked by turmoil, with Kyle Diamantas, the FDA’s top food regulator — who does not have a medical degree — stepping in as acting commissioner. Expect another stretch of agency uncertainty for sponsors managing review timelines, advisory committee scheduling, and pending AI/CDS guidance. NPRU.S. News & World Report
NPR
2. 🌐 Trade court rules Trump’s 10% global tariff unlawful
A 2-1 panel of the Court of International Trade concluded the Trump administration misread the law used to justify the sweeping tariffs, but an appeals court has since paused the ruling pending DOJ challenge. Medtech finance teams should still plan for tariff drag in their 2026 guidance — the underlying levy remains in force for now. ABC News
ABC News
3. 🎯 Most medical device companies don’t fail on technology. They fail on sequencing.
The most expensive mistakes in Class II and III device commercialization aren’t made in the field. They’re made before it — launching before buyer clarity exists, fundraising before the story holds up, hiring before positioning is right.
The CLIF Analysis from RŌG Health is a fast, structured external diagnostic designed to surface those gaps before they become costly. One week. Built for medical device and medtech teams.
Sponsored
4. 💸 Stryker closes Amplitude Vascular deal at up to $835M
Stryker paid approximately US$435 million upfront, with the agreement also including up to US$400 million in future milestone-based payments for Amplitude’s CO₂-generated pressure wave IVL platform, putting Stryker into a peripheral arterial disease market already populated by J&J, Boston Scientific, and Abbott. Tuck-ins around hot procedure categories remain the dominant M&A pattern of 2026. FW Africa
Endovascular Today
5. 📊 Elliott lands two board seats at Dexcom
Dexcom agreed to grant Elliott Investment Management, one of its largest shareholders, two independent seats on its board, with the existing technology committee being reconstituted as an operations and innovation committee with added quality oversight. After Elliott’s earlier run at Medtronic, this is now a recognizable playbook — and a signal to other large-cap medtechs about portfolio focus and execution discipline. Seeking Alpha
Seeking Alpha
6. 🤖 Bayesian Health wins first FDA clearance for continuous AI sepsis monitor
The Johns Hopkins spinoff’s Targeted Real-time Early Warning System (TREWS) became the first continuous AI sepsis monitor to gain FDA approval, having already been deployed at Cleveland Clinic, University of Rochester Medicine, and MemorialCare under breakthrough designation. Worth tracking as a real-world test of how always-on AI surveillance gets reimbursed, embedded in EHRs, and audited post-market — Bayesian is targeting NTAP reimbursement starting October. Beckers Hospital Review
Becker’s Hospital Review
7. 🫀 J&J launches Shockwave C2 Aero coronary IVL globally
The next-generation catheter is designed for improved deliverability, enhanced lesion crossing, and new repositioning capabilities for the treatment of calcified coronary artery disease, and is now available in the United States and Japan, with additional markets in the months ahead. Timing is no accident — it lands days before EuroPCR in Paris and just as Stryker’s Amplitude deal closes. Iteration cadence will set the tempo of the IVL competitive set.
Cardiovascular Business
8. 🇩🇪 Carl Zeiss Meditec to cut up to 1,000 jobs
The German ophthalmic and microsurgery giant plans to reduce its workforce by up to 1,000 over the next few years after revenues fell 5.7% YoY and earnings dropped nearly 66% in fiscal H1. Combined with Medtronic’s Santa Rosa site closure the week prior, the message is consistent: even healthy medtechs are tightening operating footprints heading into the back half of 2026. MassDevice
MassDevice
Put your brand in front of 35,000+ medical device and med tech leaders each week. Contact us to learn more about sponsorship opportunities.
🧭 About The Pathway
The Pathway is a curated briefing for medical device leaders, focused on regulatory moves, product launches, partnerships, and market signals shaping the industry.
If this was useful, consider subscribing or sharing with a colleague who should be tracking these developments.
Some issues may include sponsored or partner content. Sponsorship does not influence editorial selection of third-party news items.