Medtech

The FDA appears likely to approve Grail’s (GRAL) Galleri by ~1Q27 following yesterday’s advisory committee vote, though we suspect a narrowed label, removal of the word “early” from its indication for the “detection of multiple…

CMS’s preliminary CY27 rates for lab codes targeted through the next phase of adjustments under the Protecting Access to Medicare Act (PAMA), released last night, appear largely consistent with the ~$100 M risk projections previously…

CMS’s finalized national coverage determination (NCD) last night should support an incremental ~120 bps in growth for EW’s TAVR franchise in 2027, with the agency largely codifying the criteria initially outlined in its June proposal….

With CMS set to release its finalized update to the TAVR NCD by Sept. 13 [likely posted after the close here], we largely expect it to maintain the core elements of the original proposal. More…

This fall seems likely to be a busy one for medtech and biopharma, with key policy catalysts coming up for a number of companies. These span from both the far-reaching in terms of most favored…

Following HTFL’s strong 2Q26 results, we have received a number of questions on how Medicare hospital outpatient reimbursement might evolve in light of CMS’s proposal to eventually establish a new payment paradigm for software as…

With GKOS’s strong 2Q26 results coming on the heels of five separate MAC stakeholder meetings on the draft iDose LCDs issued in late May, we suspect the final policy – likely out in Oct. /…

While a longer-term thematic positive, we are skeptical Friday’s draft notice [Fact Sheet] outlining the RAPID device Medicare coverage pathway will offer meaningful near-term benefits for industry amid agency capacity constraints. Coming nearly four months…

Today’s final coverage decision on organ allograft rejection testing represents a clear positive for CareDx (CDNA), with meaningful improvements over both last year’s initial proposal and even our own expectations, likely neutralizing what had been…

We view positive rate changes for SI-BONE’s (SIBN) iFuse 3D / TORQ and negative adjustments for Boston Scientific’s (BSX) Watchman as the most notable items for investors following release of CMS’s draft CY27 Physician Fee…