Approvals

Subtle Medical Cleared for AI-Powered Imaging Tech

Subtle Medical’s SubtlePET, a positron emission tomography (PET) imaging system driven by AI technology, was granted 510(k) clearance by the FDA. The device recently received a CE Mark in Europe.

The device can be used by hospitals and imaging centers to enhance images and speed up scanning times for PET scans.

Because the technology is able to reduce scanning times, it is capable of increasing the number of scans health care professionals can run each day.

FDA Clears Bausch + Lomb’s Multifocal Toric Lens

Bausch + Lomb’s ULTRA Multifocal for Astigmatism contact lenses received the FDA’s go-ahead in a 510(k) clearance.

The monthly silicone hydrogel lens were developed to help patients correct astigmatisms without needing custom lenses or glasses.

Patients can be immediately fitted by eye care professionals with a diagnostic version of the newly approved contact lenses.

SpeeDx Gains CE Mark for Gonorrhea Test

SpeeDx’s ResistancePlus GC gonorrhea assay has earned the CE Mark.

The polymerase chain reaction test detects gonorrhea and allows doctors to assess the disease’s susceptibility to the antibiotic ciprofloxacin before prescribing.

The assay is the first commercially available molecular test in the EU that provides information on the disease’s antibiotic susceptibility.

FDA Clears Edwards Lifesciences’s Hemodynamic Monitoring Platform

Edwards Lifesciences’ latest HemoSphere advanced hemodynamic monitoring platform received 510(k) clearance from the FDA.

The device includes solutions that enable predictive monitoring of moderate- to high-risk surgical patients, such as its Acumen hypotension prediction index software, which uses AI to determine the likelihood of a low blood pressure event.

HemoSphere also includes a minimally-invasive sensor that automatically updates advanced hemodynamic parameters every 20 seconds.

Contego Medical Cleared for Angioplasty System

The FDA granted 510(k) clearance for Contego Medical’s Vanguard IEP peripheral balloon angioplasty system.

The device is designed to protect patients that are vulnerable to embolization — the passage and lodging of an object, such as a blood clot, in the blood stream — during peripheral angioplasties, in which a surgeon repairs or unblocks blood vessels.

The system, which has an over-the-wire design, can protect the patient’s lower limbs during angioplasty and requires no additional devices or exchanges.