A Private Device Company Just Put Its Pivotal Trial Head to Head Against the Market Leader
VDyne treated the first patient in a pivotal trial randomising its tricuspid valve replacement head to head against Edwards’ commercially available EVOQUE.
MedTech
NICE Said Yes to the Lung Machine, and Then Attached Four Years of Conditions
NICE conditionally recommended the XVIVO perfusion system for NHS use, with four years of evidence generation and a hub model to end the postcode divide.
Abbott Is Not Testing Whether TriClip Works. It Is Building the File That Gets It Paid.
Abbott began a 1,000-patient, five-year post-market study of TriClip across 100 sites, generating the durability evidence payers and guidelines require.
One Robot, Three Ways In: Momentis Clears Multiport a Day After J&J Shrank the Footprint
Momentis won FDA clearance for multiport surgery, making Anovo the first robotic platform cleared for natural orifice, single-port and multiport approaches.
A Company Called StrokeDx Just Cleared a Device That Is Not Cleared to Detect Stroke
NeuraNova, formerly StrokeDx, won FDA clearance for a bedside device measuring cerebral fluid asymmetry, cleared as an adjunct rather than a diagnostic.
PRIMA Can Be Sold in 30 Countries Tomorrow. Reimbursement Is the Real Timeline.
Science Corp’s retinal implant won a CE mark for sale across 30 European countries, after trial patients gained a mean 25.5 letters of visual acuity.
J&J Built Its Surgical Robot Into the Table, and Aimed It at the 92% of Surgery That Isn’t Robotic
The FDA granted De Novo authorization to OTTAVA, the first surgical robot with arms built into the operating table, cutting the footprint by up to half.
A Geneva BCI Company Records Its First Human Neural Data, and Europe Gets a Serious Entrant
ABILITY Neurotech recorded human neural data for the first time during tumour surgery in Munich, its first step toward a long-term implantable brain-computer interface.
The Only Non-Drug Pediatric ADHD Device Launches Its Second Generation Into a 1,500-Family Waitlist
The only FDA-cleared non-drug treatment for pediatric ADHD launched its second generation into a 1,500-family waitlist, with reimbursement still the open question.
A Father’s Liver, One Incision: the First Single-Port Robotic Liver Transplant Lands in a Six-Year-Old
A six-year-old with a rare genetic liver disorder became the first patient to receive a liver transplant through a single robotic incision, donated by his father.