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Medical Devices

TECNIS PureSee IOL

Johnson & Johnson · FDA premarket approval

An extended-depth-of-focus IOL with contrast comparable to a monofocal.

Clinical summary

A purely refractive extended-depth-of-focus intraocular lens for primary implantation after cataract removal in adults with less than 1 diopter of corneal astigmatism. Contrast sensitivity was comparable to an aspheric monofocal IOL, and 97% of patients reported no very bothersome halos or glare. Labeling excludes several ocular comorbidities, including uncontrolled glaucoma, macular disease and diabetic retinopathy.

Read the primary source: Johnson & Johnson press release
Medical Devices

Optune Pax

Novocure · FDA premarket approval

A wearable Tumor Treating Fields device for locally advanced pancreatic cancer.

A portable, non-invasive device that delivers alternating electric fields (Tumor Treating Fields) to the abdomen to disrupt cancer cell division, worn alongside gemcitabine plus nab-paclitaxel in adults with locally advanced pancreatic cancer. In the PANOVA-3 trial it extended overall survival by about two months over chemotherapy alone. Skin reactions under the transducer arrays were the most common device-related adverse event.

Drugs

Juvmo (tavapadon)

AbbVie · FDA approval

First selective D1/D5 dopamine agonist approved for Parkinson's disease.

A once-daily oral tablet for adults with Parkinson's disease, with or without levodopa; unlike existing agonists, which act mainly on D2/D3 receptors, it selectively activates D1/D5. In TEMPO-3, as adjunct to levodopa in patients with motor fluctuations, daily 'on' time without troublesome dyskinesia rose by 1.7 hours versus 0.6 hours with placebo. Warnings include orthostatic hypotension, hallucinations, dyskinesia and impulse-control urges.

Medical Technology

Libre Duo

Abbott · FDA De Novo

First wearable sensor that tracks ketones and glucose together.

A 10-day sensor for people with diabetes aged 2 and older that measures ketones and glucose in interstitial fluid every minute and sends readings, trends and rising-level alerts to a smartphone. Across six clinical studies in more than 600 participants it tracked clinically meaningful ketone differences, including elevated ketones before the onset of diabetic ketoacidosis. Ketone readings should be interpreted with glucose values and symptoms, and do not replace confirmatory testing before treatment decisions.

EndocrinologyView Innovation