FDA Clears MC10’s Biometric Data Collection System
The FDA granted 510(k) clearance to MC10’s BioStamp nPoint system, a platform used for healthcare data collection.
The system can continuously collect physiological data in home or traditional healthcare settings. It is designed to be used in clinical trials and research studies, and includes a rechargeable body-conforming sensor. It can measure vital signs, sleep metrics, general activity and postural classifications.
Casmed’s OEM Version of Tissue Oximeter Cleared by FDA
The FDA approved Casmed’s original equipment manufacturer version of its Fore-Sight Elite tissue oximeter.
The device displays tissue oximetry values through a Fore-Sight technology cable connected to sensors on the patient’s forehead. It is designed for minimal user-interface modifications for use with third party monitors.
StimGuard Approved for Sacral Nerve Stimulator
StimGuard’s wireless neuromodulation device received a CE Mark for treating chronic, persistent symptoms of overactive bladder.
The device injects a therapy using a needle and can be configured using an Apple iPad for advanced programming. It eliminates the need for implantation of a battery source in the patient, which requires surgery.
The nerve stimulator places a small device equipped with electrode contacts and an embedded chip in the patient’s body through a needle paired with a wire receiver.
Additive Orthopedics Announces FDA Clearance of 3D Printed Bone Segments
Additive Orthopedics received 510(k) clearance for its patient-specific 3D printed bone segments, used to address internal bone fixation in the ankle and foot.
The printed bone segments are used in certain cases of limb salvage, trauma and implant revision when there are few clinically available devices to address the patient’s condition.
The segments use a lattice structure to promote bone-in growth instead of older, more open types of structures that use biologics for osteosynthesis.
Embotrap II Cleared for Treating Ischemic Strokes
The FDA granted marketing clearance to Cerenovus’ Embotrap II for treatment of ischemic stroke, a mechanical thrombectomy device designed to retrieve blood clots from the brain.
The 510(k) application included results from the ARISE II trial of 228 patients at 11 U.S. and 8 European sites. The study found that physicians successfully restored blood flow in 80.2 percent of patients within 3 passes and in 51.5 percent of patients within a single pass.
The stent retriever can be used up to eight hours after the patient experiences stroke symptom onset and patients ineligible for IV tissue plasminogen activator therapy are candidates for treatment.
Motus GI’s Pure-Vu System Receives Chinese Patent
The Chinese Patent Office awarded Motus GI a patent for its Pure-Vu System for cleaning the colon during colonoscopy procedures to improve visualization.
The device integrates with standard colonoscopes to enable cleaning during the procedure while preserving standard procedural workflow and techniques.
The system previously received 510(k) clearance from the FDA and CE Mark approval in Europe. It is currently being introduced on a pilot basis in the U.S. market. The company is planning to initiate a broader commercial launch in the U.S. and select international markets in 2019.
Xtant Cleared for Cervical Interbody System
The FDA gave Xtant 510(k) marketing clearance for its InTice-C porous titanium cervical interbody system, a scaffold material used for implant fixation.
The material is used as a bioactive scaffold and is cleared for use alongside Xtant’s proprietary allograft lines, including the company’s OsteoSponge, cortical fibers and viable cell allograft products.
InTice-C gives cervical intervertebral body fusion options for differing patient anatomies and comes in multiple footprint, height and endplate options.
Flow Cytometry-Based Test for HPV Receives CE Mark
IncellDx received a CE Mark for its HPV OncoTect 3Dx flow cytometry assay for human papillomavirus. The assay enables women to go beyond cervical cancer screening tests in determining if they are infected with a high-risk strain of HPV.
The test provides results in four hours, including the quantification of oncogene mRNA overexpression, proliferation and abnormal numbers of chromosomes.
The assay enables the identification of ectocervical cells and quantifies the percentage of cells that overexpress E6 and E7 mRNA.