Rapid point-of-care (POC) diagnostics company Lumos Diagnostics Holdings Pty. Ltd. has had its hopes of entering the U.S. market dashed yet again following a second decision from the FDA that Febridx has not demonstrated substantial equivalence to the predicate device identified in its 510(k) application.
Clearpoint Neuro Inc. said Clinical Laserthermia Systems AB (CLS), snared a 510(k) from the FDA for a laser interstitial therapy system that will be marketed in the U.S. as part of the Clearpoint Prism Neuro system. This product package adds to a growing Clearpoint footprint in the neurological disorders space, adding to an inventory that already consists of targeted drug delivery and deep brain stimulation systems.
With FDA 510(k) clearance of its Kinguide robotic-assisted surgical system, Point Robotics Medtech Inc became the first robotics company in Taiwan to gain U.S. clearance for an orthopedic surgical robot.
Baxter International Inc. has scored FDA clearance for an infusion pump used to deliver small amounts of fluid at low rates, often in pediatric, neonatal and anesthesia care settings. The Novum Iq syringe infusion pump also features Dose Iq Safety Software, a web-based, customizable drug library that incorporates titration technology to reduce dosage errors during patient treatment.
Magnus Medical Inc. received FDA clearance for a neuromodulation platform to treat major depressive disorder (MDD) in adults for whom antidepressant medication has been ineffective.
Medtronic plc has received U.S. FDA 510(k) clearance and breakthrough device designation for its Ligapass 2.0 ligament augmentation system in spine surgery. The surgical treatment is designed to reduce the reoperation rate for proximal junctional kyphosis (PJK), a complication of adult spinal deformity surgery which disrupts spinal ligaments. Ligament augmentation provides strength to the upper instrumented vertebra and adjacent segments while also reducing junctional stress at those levels.
Outset Medical Inc. dropped 38% during intraday trading to reach its lowest point since going public in mid-2020 following its announcement that it began holding shipments of its Tablo hemodialysis system for home use in late May pending U.S. FDA clearance of a 510(k) submission for changes made to the device since its original clearance in March 2020. The stock which closed June 13 at $20.43, recovered some ground to close June 15 at $14.58, which is still 78% off the stock’s high in November 2020.
Tel Aviv-based startup Scopio Labs Ltd. has received U.S. FDA 510(k) clearance for its artificial intelligence (AI) powered cell morphology platform, X100HT. The laboratory device is designed to locate and display images of white cells, red cells and platelets acquired from fixed and stained peripheral blood smears. Analysis of the images is then provided using AI technology.
The U.S. FDA determined that the pandemic required an adjustment to applicant turn-around times for the agency’s responses to regulatory filings, an allowance that was unavoidable given the impact of the pandemic on applicants’ ability to respond. That policy has now been reversed, the agency said, which means that a failure to respond to queries about 510(k) filings within 180 days will lead to an assumption on the agency’s part that the applicant has withdrawn the submission.
