Freenome’s Lung Test Is Indicated for People Who Never Show Up
Freenome defined its population by the failure of the existing pathway, not by anything measurable in the patient. That is the decision worth reading.
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No Product Is Approved for Hernia Prevention. BD Is Spending Five Years to Change That.
BD is not testing a product against a competitor. It is testing whether an indication can be brought into existence, with no label, code or precedent.
Korea Cleared Two Diagnostics on One Day, and Both Remove a Specialist
Nobody gained insurance access. Designation is the gate before the negotiation. The real story is that both lead technologies remove a specialist.
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.
ITM’s Complete Response Letter Names No Clinical Concern. It Names a Third-Party Facility.
COMPETE hit its endpoint and is published in The Lancet. The FDA did not touch any of it. What stopped the approval is a facility ITM does not own.
DuPont Spun Chemours Off in 2015. Eleven Years On, Both Are Named in the Same Order.
QuickCI read/Legal & Policy/Medtech DuPont Spun Chemours Off in 2015. Eleven Years On, Both Are Named in the Same Order. Athithi Verma· 11 August 2026· 3 min read· Synopulse Chief Judge Renée Marie Bumb of the US District Court for New Jersey approved settlements worth more than $2.5 billion on 7 August 2026, resolving claims … Read more
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
MoonLake Says IZAR-1 Met Every Endpoint and Will Not Show You the Placebo Arm
MoonLake disclosed 42.1% ACR50 and withheld the placebo arm. An absolute response rate without a comparator is a number, not a result.
Teledyne Put Its Antitrust Argument in the Press Release, Product by Product
Mehrabian spent a paragraph itemising exactly how the two businesses do not overlap. Executives do that when a competition authority is reading.