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Medical Technology

Libre Duo

Abbott · FDA De Novo

First wearable sensor that tracks ketones and glucose together.

Clinical summary

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.

Read the primary source: FDA press release

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Medical Technology

OTTAVA Robotic Surgical System

Johnson & Johnson · FDA De Novo

The first soft-tissue surgical robot with its arms built into the operating table.

Authorized for upper-abdominal general surgery, including Roux-en-Y gastric bypass, sleeve gastrectomy, cholecystectomy, fundoplication and hiatal hernia repair. Its four robotic arms are integrated into the operating table rather than mounted on carts, which the company says takes 30 to 50% less floor space. It is a first-generation system in a limited US rollout, and the announcement cites no comparative outcome data.

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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.

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Diagnostics

SimpleScreen CRC

Freenome · FDA approval

A second blood-based colorectal cancer screening test reaches the US market.

A cell-free DNA blood test for colorectal cancer screening in average-risk adults aged 45 and older, commercialized in the US by Abbott. In PREEMPT CRC (more than 48,000 participants), sensitivity for colorectal cancer was 81.1% and specificity 90.4%, but sensitivity for advanced precancerous lesions was only 13.7%. A positive result must be followed by colonoscopy, and the test does not replace colonoscopy in high-risk patients.

GastroenterologyView Innovation