Tag: cms

5 articles

Market Moves

Inspire Medical cuts 2026 guidance to $825-875M as CMS WISeR consumes the bull case

Inspire Medical Systems reported Q1 2026 revenue of $204.6 million (up 1.6% year-on-year) on 4 May 2026 and cut full-year 2026 guidance to $825-875 million from the prior $950 million-$1 billion range issued in February. The company attributed approximately $20 million of Q1 impact to CMS WISeR prior authorization and CPT code transition uncertainty. Bank of America analyst Travis Steed downgraded the stock from Neutral to Underperform.

May 26

Market Moves

NeuroPace beats Q1, raises guidance, and posts 77% seizure reduction in expanded-indication trial

NeuroPace reported Q1 2026 RNS System revenue of $21.7 million (up 19.5% year-on-year), raised full-year guidance to $99-101 million, and detailed 18-month NAUTILUS trial data showing a 77% median reduction in generalised tonic-clonic seizures. FDA paused the 180-day clock on the expanded-indication review; midyear determination still anticipated.

May 18

Policy & Regulation

Inspire takes the first quantified WISeR hit as Medicare bifurcates its neuromodulation posture

Inspire's Q1 2026 print attributes a combined $120 to $150 million FY26 hit to WISeR plus coding uncertainty, six sell-side analysts cut targets through 7 May, and NeuroPace just received a 43% to 47% Medicare reimbursement increase on the same rule cycle.

May 8

Market Moves

China issues guided pricing for invasive BCI procedures as provinces begin reimbursement roll-out

China's National Healthcare Security Administration has set government-guided prices of 6,000–6,600 yuan per invasive brain-computer interface implantation procedure, with Sichuan, Hubei and Zhejiang now attaching fee schedules at the provincial level — moving the country further ahead of the United States on the reimbursement layer that will decide whether BCIs scale as routine medicine.

Apr 23

Industry News

FDA signals long-horizon regulatory commitment as CorTec joins Total Product Life Cycle Advisory Program

Two weeks after securing Breakthrough Device Designation for stroke rehabilitation, CorTec has been accepted into the FDA's TAP — a dedicated advisory track that pairs the German neurotech company with an agency liaison and early engagement with CMS, signalling an unusually long regulatory horizon for an implanted brain-computer interface.

Apr 23

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