Tuesday May 26, 2026
Hope you enjoyed Memorial Day (U.S.) and got some real time away from the inbox. A late start to the week, but a heavy one to catch up on.
Cardiovascular set the tone over the past two weeks. J&J extended the Impella controller saga with a new correction tied to one death and two injuries. Boston Scientific posted positive pivotal data for its coronary IVL catheter and put $1.5 billion behind a TAVR upstart. Stryker disclosed it paid up to $835 million for Amplitude Vascular, sharpening competition in lithotripsy on multiple fronts at once. Around the edges: Medtronic and Olympus each added portfolio pieces, and the FDA cleared the first AI tool for continuous sepsis monitoring.
8 things to watch this week:
1. ⚠️ J&J Impella controller restart linked to one death, two injuries
The FDA issued an early alert after Johnson & Johnson’s Abiomed unit identified a software error that can force the Automated Impella Controller to restart for roughly 35 seconds mid-procedure, leaving patients unsupported. Abiomed sent customers updated use instructions on May 14 and is working on a software fix. The action extends a string of Impella controller corrections that began last summer.
MassDevice
2. 🧠 Medtronic to acquire SPR Therapeutics for $650M
Medtronic agreed to buy Cleveland-based SPR Therapeutics for roughly $650 million in cash, adding the FDA-cleared SPRINT peripheral nerve stimulation system to its neuromodulation portfolio. SPRINT delivers up to 60 days of temporary electrical stimulation through a percutaneous lead, giving Medtronic a minimally invasive option to intervene earlier in the chronic pain pathway. It’s Medtronic’s third major acquisition this year.
Fierce Biotech
3. 💗 Boston Scientific’s third swing at TAVR: $1.5B for a 34% stake in MiRus
Boston Scientific invested $1.5 billion for an approximately 34% equity stake in MiRus and an exclusive option to acquire the company’s SIEGEL balloon-expandable TAVR system through additional milestone-tied payments totaling $3 billion. The structure gives Boston Scientific a defined path back into structural heart after exiting the Acurate program last year — and a third attempt at TAVR after two prior failed efforts.
MD+DI
4. 💥 Stryker’s Amplitude Vascular deal valued at up to $835M
In a 10-Q filing, Stryker disclosed it paid approximately $435 million upfront for Amplitude Vascular Systems, with up to $400 million in milestone payments tied to regulatory and commercial targets. The investigational Pulse IVL system uses CO₂-generated pressure waves delivered through a balloon catheter to treat calcified peripheral arterial disease. The deal places Stryker squarely in an IVL market now contested by J&J/Shockwave, Abbott, and Boston Scientific.
MassDevice
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6. 🔬 Boston Scientific’s SEISMIQ coronary IVL hits primary endpoints in FRACTURE
Boston Scientific reported positive pivotal results for its SEISMIQ 4CE coronary intravascular lithotripsy catheter at EuroPCR 2026, with a 93.3% rate of freedom from major adverse cardiac events at 30 days and 93.7% procedural success across 420 patients with severely calcified coronary artery disease. The data supports a planned FDA submission and positions Boston Scientific to compete directly with J&J’s Shockwave franchise in coronary IVL.
AJMC
7. 🧬 Olympus to buy Israel’s BioProtect for $270M to expand in prostate cancer
Olympus agreed to acquire BioProtect for $270 million, picking up the company’s biodegradable balloon spacer used to separate the prostate from the rectum during radiation therapy. The device has been used in more than 11,000 procedures worldwide since its 2023 commercial launch. The deal extends Olympus’ push into oncology adjacencies after a multi-year portfolio reshaping around endoscopy and therapeutic solutions.
Medical Device Network
8. 🤖 Bayesian Health lands first-ever FDA clearance for continuous AI sepsis monitoring
The FDA granted 510(k) clearance to Bayesian Health’s TREWS platform — the first AI tool to clear the agency for continuous sepsis monitoring rather than rule-based EHR alerts. Built by Johns Hopkins researchers, the system showed 82% sensitivity for early sepsis detection in a prospective study published in Nature Medicine, and patients were 18% less likely to die in the hospital when clinicians acted on its alerts in time. Bayesian is positioning for a CMS New Technology Add-on Payment decision in early August.
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The Pathway is a curated briefing for medical device leaders, focused on regulatory moves, product launches, partnerships, and market signals shaping the industry.
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