HeyJaredThe Pathway
The Pathway is a curated briefing for medical device leaders—tracking FDA/regulatory updates, new device launches, clinical signals, funding, and M&A. Short, timely, and focused on what matters.
- Indexed issues, last 90 days
- 14
- Latest publication
- Sep 28, 2026
- Audience
- Checking…
- Earliest in this view
- Aug 13, 2026
Latest issues
Monday, September 28, 2026 (opens the original)
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Most of this week’s news came from people with the standing to say no. FDA put its expectations for surgical robots in writing and a Class I label on a heart-pump controller, an advisory panel split over the first multi-cancer blood test, an activist told Cooper’s board to find a new CEO, and Fresenius decided the cheap end of China wasn’t worth the factory. Hospitals, for their part, were told to keep running the recalled Impella controllers and just switch to the backup when the alarm goes off
Thursday, September 24, 2026 — Field Note (opens the original)
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FIELD NOTEMedicare's lab pay reset finally lands, and molecular diagnostics absorb the deepest cuts.<img alt="" class="sizing-normal" height="819" src="https://substackcdn.com/image/fetch/$s_!L_EF!,w_1456,c_limit,f_auto,q_auto:good,fl_progressive:steep/h
Monday, September 21, 2026 (opens the original)
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The FDA handed out four authorizations this week and the most consequential wasn't a clearance at all — it was a new classification, created for AI that reads ECGs. Add Britain proposing to regulate software functions rather than whole products, and the regulatory frame is widening faster than most commercial plans account for. Also, a brain implant let someone answer a question out loud.Get the very latest in news and updates for medical device leaders right in your inbox.
Thursday, September 17, 2026 — Field Note (opens the original)
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FIELD NOTEJ&J paid $400 million for an early-stage heart device. Three years later, the team that built it owns it again.<img alt="" class="sizing-normal" height="819" src="https://substackcdn.com/image/fetch/$s_!Zzu9!,w_1456,c_limit,f_auto,q_auto:goo
Monday, September 14, 2026 (opens the original)
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Last week was about follow-through. CMS finally acted on the EARLY TAVR data it has been sitting on since 2024. Stryker learned that a March cyberattack has a longer tail than it told investors in July. Intuitive answered two new competitors with 14 million cases of evidence. Zimmer Biomet rebuilt its org chart around a robot that doesn't ship until 2027. Announcements are cheap; this was a week of paying for them.Get the very latest in news and updates for medical device leaders right in
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