The Pathway

The Pathway

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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.

Tuesday May 5, 2026
BlogMay 5, 2026

Tuesday May 5, 2026

Johnson & Johnson released first‑in‑human data for its OTTAVA robotic surgical system, showing safety and performance success in a 30‑patient gastric bypass cohort and filing a De Novo request with the FDA. The week also saw the US‑China tariff truce...

By The Pathway
Monday April 27, 2026
BlogApr 27, 2026

Monday April 27, 2026

Policy and market forces converged this week as CMS and the FDA launched the RAPID coverage pathway, slashing Medicare approval timelines for breakthrough devices from over a year to as little as two months for roughly 40 qualifying products. Meanwhile,...

By The Pathway
Thursday April 23, 2026 — Field Note
BlogApr 23, 2026

Thursday April 23, 2026 — Field Note

Stereotaxis announced a deal to acquire robotic PCI developer Robocath for up to $45 million, including a $20 million cash upfront payment and up to $25 million in milestone‑based earn‑outs tied to regulatory and commercial progress. The acquisition brings Robocath’s R‑One+ platform—currently CE‑marked...

By The Pathway
Thursday April 16, 2026 — Field Note
BlogApr 16, 2026

Thursday April 16, 2026 — Field Note

AI startup Luminai announced a $38 million Series B round to expand its intelligence platform across health‑system operations. The funding, led by PHTI, backs a partnership with the Cleveland Clinic, which serves roughly 15 million patients annually, focusing initially on referral‑management workflows. Luminai...

By The Pathway
Monday April 13, 2026
BlogApr 13, 2026

Monday April 13, 2026

This week’s medtech briefing highlights a surge of strategic deals and capital flowing into neurovascular and AI‑enabled health solutions. Stryker announced the acquisition of Amplitude Vascular Systems to add intravascular lithotripsy to its peripheral‑vascular portfolio, while Gilead agreed to buy...

By The Pathway
Thursday April 9, 2026 — Field Note
BlogApr 9, 2026

Thursday April 9, 2026 — Field Note

Boston Scientific’s Watchman FLX left‑atrial appendage closure device demonstrated non‑inferiority to direct oral anticoagulants (DOACs) on a composite endpoint of cardiovascular death, stroke and systemic embolism in the CHAMPION‑AF trial presented at ACC.26 and published in NEJM, and it achieved...

By The Pathway
Monday March 30, 2026
BlogMar 30, 2026

Monday March 30, 2026

The medical device landscape is accelerating across multiple fronts. Medtronic secured FDA clearance to extend its robotic platform into cranial and ENT surgeries, while Boston Scientific introduced a fluid‑management system for ureteroscopy. At‑home neuromodulation received a $6 million infusion after FDA...

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