FDA Updates

The US FDA announced its first-ever approval of an artificial intelligence device to help find colon lesions during colonoscopy.

The GI Genius (Cosmo Artificial Intelligence) identifies areas of the colon where a colorectal polyp or tumor might be located. Clinicians then follow up with a closer examination and possible treatment.

The GI Genius consists of both hardware and software designed to work with an endoscope. It uses machine learning to recognize possible polyps during a colonoscopy. It marks these areas with green squares on the video generated by the endoscope’s camera and emits a short, low-volume sound. Clinicians decide if a lesion is truly present and whether to sample or remove such a lesion.

The device does not diagnose the lesions or recommend treatments and is not intended to take the place of laboratory sampling

The FDA based its approval on a trial in which 700 people 40-80 years of age underwent colonoscopies for colorectal cancer screening, surveillance, follow-up from positive results of a fecal occult blood test, or gastrointestinal symptoms of possible colon cancer.

Of these participants, 263 were being screened or surveilled every 3 years or more. The researchers randomly divided them into a group of 136 who underwent white-light standard colonoscopy with the GI Genius, and 127 who underwent white-light standard colonoscopy without the GI Genius.

Using the GI Genius, clinicians identified adenomas or carcinomas that were later confirmed through lab results in 55.1% of patients. Without the GI Genius, the clinicians identified such lesions in 42.0% of patients.

The patients examined with the GI Genius received more biopsies, including slightly more that were not adenomas. But the biopsies did not lead to any adverse events such as perforations, infections, bleeding, or further biopsies.

Source: FDA

The US FDA has approved the Portable Neuromodulation Stimulator for the short-term treatment of walking impairments as a result of mild to moderate symptoms from multiple sclerosis (MS).

PoNS is a prescription-only device intended to be used in combination with a supervised therapeutic exercise program in patients aged 22 years and older with MS.

PoNS is a neuromuscular tongue stimulator that generates electrical pulses that stimulate the trigeminal and facial nerves, sending neural impulses to the brain stem, which is thought to enhance neuroplasticity to address motor deficits.

The device’s controller and mouthpiece are connected to each other by a cord. The mouthpiece is held in place by the lips and teeth and the control unit is worn around the neck during a patient’s visit with a therapist.

In a randomized, controlled, double-blind trial involving 20 patients with MS-related gait deficits, 10 patients used the PoNS device and 10 used a sham control device that did not deliver stimulation.

No serious safety adverse events were reported in clinical studies or separate real-world data provided by the company, the FDA said.

The PoNS device should not be used by patients with penetrating brain injuries, neurodegenerative diseases, oral health problems, chronic infectious diseases, unmanaged hypertension or diabetes, pacemakers, and/or a history of seizures.

Source: FDA

The US FDA has approved Medtronic’s Harmony Transcatheter Pulmonary Valve (TPV) System to treat severe pulmonary regurgitation in pediatric and adult patients who have a native or surgically repaired right ventricular outflow tract (RVOT).

The Harmony TPV is the first nonsurgical heart valve to treat severe pulmonary valve regurgitation, which is common in patients with congenital heart disease.

The Harmony valve, which was granted breakthrough device designation, is a 22 mm or 25 mm porcine pericardium valve, sewn to a nitinol frame. It is implanted with a 25-French delivery system using a coil-loading catheter.

The FDA approval was based on the 70-patient prospective, nonrandomized, multicenter Harmony TPV Clinical study, in which 100% of patients achieved the primary safety endpoint of no procedure or device-related deaths 30 days after implantation.

Among 65 patients with evaluable echocardiographic data, 89.2% met the primary effectiveness endpoint of no additional surgical or interventional device-related procedures and acceptable heart blood flow at 6 months.

Adverse events included irregular or abnormal heart rhythms in 23.9% of patients, including 14.1% ventricular tachycardia; leakage around the valve in 8.5%, including 1.4% major leakage; minor bleeding in 7.0%, narrowing of the pulmonary valve in 4.2%, and movement of the implant in 4.2%.

The Harmony TPV device is contraindicated for patients with an infection in the heart or elsewhere, for patients who cannot tolerate blood thinning medicines, and for those with a sensitivity to nitinol (titanium or nickel).

Source: FDA