1. Acera Surgical partners with Telos Medical for Restrata wound matrix trial
Telos Partners announced in a Sept. 14 press release that Acera Surgical has chosen Telos to lead its Restrata wound matrix study. The study will surgery the clinical outcomes of Restrata treatments for diabetic foot ulcers and test for effectiveness and safety. Restrata is a fully synthetic wound matrix that is FDA-cleared for wound indications.
2. Pinnacle Sciences launches mask-mounted CPAP machine
Pinnacle Sciences has recently developed a portable, battery-operated ventilating CPAP mask for sleep apnea, according to a Sept. 14 press release. The device has several modes of therapy and fits directly on the mask to reduce the amount of dead space. Lower pressures are used in this devices meaning patient comfort will be significantly increased, according to the company. The device is also able to be used with a tube, mounted on clothing or put in a pocket. It is expected to cost around $330. Variations of the device will include full ventilation, cough assistance and high-frequency modes.
3. Plusoptix launches pediatric vision screener
Plusoptix announced in a Sept. 14 press release that it has released its new plusoptiX S16 series vision screening device for use in pediatric clinics. The plusoptiX S16 is designed to help pediatricians easily and reliably detect eye disorders early on in children. They can get reliable measurement values for refraction, pupil diameter, pupil disease and symmetry of corneal reflexes to help detect conditions use as amblyopia (lazy eye) including hyperopia (farsightedness), myopia (nearsightedness), astigmatism (blurred vision), anisometropia (unequal refractive power), anisocoria (unequal pupil size) and strabismus (eye misalignment). The device is stationary and can be connected to a network server to exchange data.
4. Fresenius expands Malaysia plant
Fresenius has expanded its Bandar Enstek, Malaysia manufacturing plant, according to a Sept. 14 press release. The expansion has added Malaysia’s first Peritoneal Dialysis products to its manufacturing facility in addition to the company’s high-quality hemodialysis concentrates and disinfectants.
5. Contego launches Entrap embolic protection study
Contego Medical announced in a Sept. 12 press release that the study for its IEP Peripheral Balloon Angioplasty System has been initiated. The study, known as the ENTRAP study, will evaluate the safety and device performance and plans to enroll up to 130 participants in centers in Belgium and Germany. The system is designed to protect lower limbs during angioplasty without additional devices or exchanges.
6. OBP Medical wins Canadian regulatory approval for OneTrac
OBP Medical has received regulatory approval from Health Canada for its OneTrac surgical retractor, according to a Sept. 13 press release. OneTrac is the first, single-use, cordless surgical retractor that has integrated LED lights and a smoke evacuation channel. It gives clinicians optimal access, illumination and exposure to issue pockets and cavities during surgery.
7. Xtant Medical wins expanded FDA clearance for Irix A
Xtant Medical announced in a Sept. 12 press release that it has received FDA 510(k) clearance for its Irix-A interbody spacer. The clearance gives the device three additional size configurations to expand its market opportunity. This clearance is the second clearance the company has received during this quarter. The Irix-A device is a standalone interbody device that is used in anterior lumbar interbody fusions.