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.
MedTech
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.
Australia Cannot Settle Its Device Price Fight While the Service Sits Inside the Price
Both sides are fighting over a number nobody can produce. The evaluation went underneath them and named the reason: the service is inside the price.
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.
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.
CMS Opened a Same-Day Coverage Lane for Devices and Closed the Payment Route Underneath It
CMS Opened a Same-Day Coverage Lane for Devices and Closed the Payment Route Underneath It
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
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.
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.