FDA on Monday posted a trio of De Novo marketing OKs: for a minimally invasive spinal fusion device from Spineology, a test system for monitoring patients on heparin therapy from Instrumentation Laboratory and a powered radiofrequency toothbrush from Home Skinovations.
At the same time, the inflow of new submissions for review may have slowed in 2020.
According to FDA's latest MDUFA quarterly report, the agency had accepted 41 De Novo submissions during fiscal 2020 as of June 30, compared with 61 in the same period in fiscal 2019 and 56 in the same period in fiscal 2018. FDA's fiscal year runs from Oct. 1 to Sept. 30.
Only four accepted this year thus far have received decisions, and 37 are pending decisions. Of the 2019 submissions, 51 received decisions and 10 are pending. All 56 of the 2018 submissions received decisions.
Spineology's OptiMesh spine fusion system is among the technologies to be both submitted and receive a decision from FDA within 2020, establishing a category for intervertebral body graft containment devices. The device is an expandable system that allows surgeons to perform the procedure through small incisions. Its market OK was supported by a 102-patient investigational device exemption study, which showed substantial improvement in low back pain and a reduction in functional limitations, with no serious device-related adverse events, the St. Paul, Minnesota-based company said.
Study results included a 98% fusion rate at 24 months, as seen on CT scans assessed by two independent radiologists, and 90% "excellent" or "good" patient satisfaction scores at six, 12 and 24 months after the procedure, Spineology reported.
FDA received the submission seven months prior to giving it the greenlight. Spineology said it plans to launch the device and instrumentation to support the procedure in the first quarter of 2021.
Instrumentation Laboratory's HemosIL Liquid anti-factor Xa drug test system intended to aid in managing the therapy of patients taking heparin, an anticoagulant, or oral factor Xa inhibitors. The test system contains reagents, drug-specific calibrators and controls. FDA received the Bedford, Massachusetts-based company's submission for the product in June 2019.
Rounding out FDA's latest De Novo nods was a dental device from a consumer goods manufacturer in Israel. The U.S. authorization of Home Skinovations' ToothWave product establishes a classification for powered radiofrequency toothbrushes, which FDA describes as a toothbrush whose handles contains a radiofrequency generator with a goal of removing adherent plaque and food debris from the teeth to reduce tooth decay.
The brush's head has radiofrequency electrodes and bristles that enable the device to deliver tactile vibration and low-power radiofrequency energy to the surface of the teeth. FDA received the submission in August 2019.