Abbott Cleared the First Dual Glucose and Ketone Sensor. FDA Judged Accuracy, Not Admissions.
The label says diabetes. The clinical argument is type 1. Coverage conversations start from 2.1 million people, not 40.1 million.
Cardio-Metabolic
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.
China Will Pay One Price for 158 Conditions, Whatever the Hospital
Same disease, same payment across tiers. Of 31 DRG categories, 27 are internal medicine, where drug cost rather than theatre time drives the case.
NICE Backed a Weekly Insulin Before It Has a Licence, Then Told Prescribers to Pick the Cheapest Option
QuickAccess read/Endocrine & Metabolic/Peptide NICE Backed a Weekly Insulin Before It Has a Licence, Then Told Prescribers to Pick the Cheapest Option Athithi Verma· 25 August 2026· 2 min read· Synopulse NICE published final draft guidance recommending insulin efsitora alfa (Onswik), from Eli Lilly, for adults with type 2 diabetes. Given once weekly by pre-filled … Read more
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.
Lilly Can Sue the Sellers. It Can Only Ask the Payment Networks.
Six suits against small peptide sellers is not a strategy for a market spanning a hundred countries. It is a demonstration attached to an appeal.
FastWave’s Pivotal Trial Cannot Measure the Thing FastWave Is Selling
Everything FastWave sells is comparative. The word its chief executive used is clearance, and clearance means substantially equivalent.
The MHRA Authorised Two Obesity Drugs in Two Days. Neither Is on the NHS.
Two MHRA authorisations in two days. One drug is too common to fund, the other too rare to prioritise. Neither is on the NHS.
Corline’s Whole Pulsed Field Upside Depends on One Customer’s Regulatory Calendar
QuickCI read/Cardio-Metabolic/Medtech Corline’s Whole Pulsed Field Upside Depends on One Customer’s Regulatory Calendar Athithi Verma· 11 August 2026· 3 min read· Synopulse Corline Biomedical disclosed, under EU market abuse rules and at 08:32 on 10 August 2026, that Health Canada has granted a Medical Device Licence for Kardium’s Globe Pulsed Field System, opening the Canadian … Read more
Sphere-9 Can Ablate VT in Europe While Its US Pivotal Is Still Enrolling
Medtronic can sell Sphere-9 into ventricular tachycardia in Europe while the trial meant to prove it works in the US is only now enrolling.