Evernorth Adopts LOCUS in Three States, and States That the Review Process Is Not Changing
Three statutes across five years, discharged on one date. Evernorth says only the source of criteria changes, not the review process itself.
United States
A Jury Convicted the Philips Engineer. The Approach Came as His Plant Was Closing.
The approach came in 2017 as Philips prepared to close the plant. A site closure is a knowledge event before it is a cost event.
DOJ Settled With the In-Home Vendor, Not the Health Plan, Over Four Medicare Advantage Codes
DOJ did not settle with a health plan. It settled with the in-home vendor that supplied the codes, and named the risk-share contract as the incentive.
Avulux Won a De Novo and Created the Category Its Competitors Will File Into
Going first through a De Novo builds the road behind you. Avulux owns the claim today and has created the category rivals will file 510(k)s into.
Two FDA Device Authorisations, Two Sets of Evidence Narrower Than the Headline
Aletta matches human phlebotomists only when it agrees to attempt a draw. Narwhal cleared on bench and animal data, citing a trial with a different probe.
Two First-Ever Rare Disease Approvals Landed the Same Day. Both Were Measured by Proxy.
Pasatru’s flare benefit is clinician-assessed only. GENGLYCOS is indicated to reduce cornstarch intake. Two firsts, both measured a step from the patient.
CMS Comments Close on a Rule That Retires the Small Biotech Exemption and Shuts the Hyaluronidase Route
QuickAccess read/Oncology/Antibody CMS Comments Close on a Rule That Retires the Small Biotech Exemption and Shuts the Hyaluronidase Route Athithi Verma· 19 August 2026· 2 min read· Synopulse The 60-day comment period on CMS-4215-P closed at 5pm on 17 August 2026. The proposed rule, published in the Federal Register on 16 June 2026, would codify … Read more
A Third Centiloid Scale Just Cleared. The First Two Already Disagree at the Threshold.
Cortechs.ai clears NeuroQuant PET for Centiloid amyloid quantification, entering a field where the two incumbent scales differ by more than 10 Centiloids.
Payers Do Not Cover Wellness. In Women’s Health, That Is a Naming Decision.
The sharpest advice in the roadmap is about vocabulary. Payers will not fund wellness, and in women’s health that classification is partly a choice.
The FDA Approved a Device and a Sentence. The Sentence Is About Other Molecules.
The label credits outcomes trials run on statins and monoclonal antibody PCSK9 inhibitors. LEROCHOL is neither, and has no outcomes trial of its own.