medical-devices
15 stories tagged "medical-devices"
Mayo's Pancreatic Cancer AI Also Flags One Cancer-Free Scan in Five
Mayo's REDMOD caught 73 percent of pancreatic cancers on CT scans taken months before diagnosis, nearly double the radiologists' rate. It also flagged about 19 percent of cancer-free scans, and its lead researcher says it has not been tested at deployment prevalence.
Drugs & FDAThe PTSD Magnet Therapy Touting 68 Percent Remission Hasn't Shown Its Placebo Arm
In Wave Neuroscience's earlier sham-controlled trial, veterans on a coil built to deliver no magnetic field improved about two-thirds as much as those on active stimulation. The sham results from the trial behind its FDA clearance still haven't been posted.
Drugs & FDABlood Pressure Fell Further on the Switched-Off Ear Clip Than on the Real Device
Daytime systolic pressure fell 5.50 points on a zero-current fake ear clip and 3.15 on the active device. Queen Mary's headline said the stimulation "shows potential."
Drugs & FDASix Months Against Twelve: How Essilor's New Myopia Lens Got Called 'Twice as Fast'
Stellest 2.0's six-month numbers sat close to the original lens's one-year result from a separate trial, and a company symposium in London called that twice as fast. The children's lens is on sale abroad and has not been cleared by the FDA.
InvestigationsThe Nerve Chip You Inject Through a Needle Hasn't Eased Anyone's Pain Yet
Built with no battery and no wires and placed through a needle, the seed-sized chip could avoid some of the hardware failures behind today's spinal cord stimulator recalls. Nobody has yet shown it relieves pain in people.
Drugs & FDAThe FDA's 'Historic' Growing Heart Valve Has Been Stretched in Two Children
Children who get a new heart valve before age 2 can face up to five open-heart surgeries. Edwards' polymer valve is built to end that, and the trial behind its approval widened it in two of 62 kids.
Autoimmune & InflammationKnee Pain Fell From 7 to 3 After This Artery Procedure, but It Keeps Struggling to Beat a Fake One
Berlin doctors plugged inflamed knee vessels with gelatin beads built to dissolve within hours, and median pain fell from 7 to 3 over a year. Nobody got a sham, and the Rotterdam trial that used one calls the effect mainly placebo.
Drugs & FDAA Heart-Failure Implant Won by 40 Points on a Questionnaire Filled Out by Patients Who Knew Which Arm They Were In
Patients given Berlin Heals' microcurrent implant reported quality-of-life gains eight times the control arm's in an open-label trial. The blood marker and exercise test that could have backed them up showed no significant difference, and the company paid for the study.
InvestigationsThe HeartMate 3 Won Its Market on a Low Stroke Count. The Neurologic Events It Left Off Are Just as Common.
Eight percent of HeartMate 3 patients have a stroke. Another 8 percent have a seizure, a transient ischemic attack, or a brain bleed its headline safety score never tallied, and two-year survival in those patients runs as low as 45 percent.
Brain & AgingA Bendable Fiber Thinner Than Six Hairs Records, Doses, and Stimulates a Mouse Brain at Once
Silicon brain probes scar the tissue they're built to read. A soft optical fiber from Denmark records, doses, and stimulates neurons at once, in mice, with a pharma foundation and pending patents behind it.
Drugs & FDAThe FDA Is Building an On-Ramp for Medical AI That Can Hallucinate
The FDA has cleared more than 1,000 AI medical devices and not one large language model. Its new discussion paper starts building the pathway for the ones that can make things up, with faster delivery to market named as an agency priority.
Brain & AgingBerlin Physicists Bolted a Metamaterial to a 7-Tesla MRI, and the Living Eye Came Into Focus
It clips onto a 7-tesla scanner a hospital already owns, draws no extra power, and lifted the signal inside a living human eye by up to half.
Brain & AgingA 14-Patient Hand-Exoskeleton Study Lands in Science Advances, With a Headline That Outruns the Data
A Vienna-led team published a 14-patient feasibility study of a wearable hand exoskeleton with closed-loop electrical stimulation. The mechanism is genuinely novel; the headline is doing work the data cannot.
InvestigationsThe Hernia FAQ That Forgets to Mention the Implant
A polished hernia FAQ walks patients through recovery time, return-to-work, and lifestyle. It skips the question with 26,153 pending lawsuits behind it, and the no-mesh option the international guideline still keeps on the table.
Drugs & FDAAnother Clot Problem at Abiomed: The FDA Flags an Impella Introducer, and the Pattern Keeps Growing
FDA flags Abiomed's 14Fr Low Profile Introducer Kit after a higher than expected complaint rate of clots forming on the device during prolonged Impella CP support. Three serious injuries reported, no deaths. The pattern keeps growing.