A Class II recall involving Roche's Accu-Chek connected diabetes management app has been issued by the FDA following reports of a software bug in the app's Bolus Advisor calculator feature, an error that could cause unexpected changes in the unit of measurement. The company updated the app and recommended that users of the feature track active insulin and insulin bolus amounts carefully for a minimum of eight hours.
The Defense Advanced Research Projects Agency has awarded General Atomics Electromagnetic Systems to develop a portable medical device for use by military personnel in testing for infectious diseases. The device, which is expected to provide test results in under an hour, will build on the Portable Diagnostic Platform with disposable cartridges and sensor technology for laboratory-quality molecular diagnostic functions.
An update to Medicare's coverage policy for implantable cardiac devices has been finalized by the CMS, boosting patient access by eliminating the waiting period for patients with an existing ICD to obtain a replacement device following a heart attack or a coronary revascularization procedure. The agency also removed the description "independent" for physicians in its recommendation on shared decision-making conversation, providing clarification and minimizing unnecessary burden for providers.
A round of Series A financing has brought in about $10 million for Belgian opto-electronics developer Synergia Medical, which concentrates on medical devices for neurostimulation. The proceeds will be used to accelerate its vagus nerve stimulation device for drug-resistant epilepsy, called NAOS, through final testing before it applies for CE mark approval.
Second Sight Medical has made its entry to the Singaporean market with Mandarin Opto-Medic as its regional exclusive distribution partner for the Argus II retinal prosthesis system. The company recorded last month the first Singaporean commercial procedure of the system, which uses electrical stimulation to induce visual perception in patients with retinitis pigmentosa.
A distribution agreement has been reached by Tandem Diabetes Care with Rubin Medical for the commercialization of Tandem's devices in Denmark, Sweden and Norway. The deal calls for all sales, marketing and customer training for Tandem's t:slim X2 insulin pump, insulin cartridges and t:lock infusion sets to be performed by Rubin Medical.
Two patents related to presacral interbody fusion have been secured by TranS1 for two new expandable cages designed for lordosis creation from L5 to S1. The company, which has a patent portfolio of spinal health technologies and a portfolio of minimally invasive spine surgery products, has also earned a patent for a new sacroiliac fusion technique.
The FDA has granted artificial intelligence health care developer Viz.ai approval for its LVO Stroke platform, which is intended for analyzing computed tomography results and delivering notifications to providers regarding potential large vessel occlusive strokes. The software device, which uses deep learning, provides alerts by connecting to a hospital CT scanner and allows for direct transmission of radiological images to physicians' phones.
The FDA has granted Arterys clearance for its Arterys Oncology AI suite, which allows for measurement and monitoring of tumors or potential cancers and application of radiological standards when used along with the company's web-based offering. The technology is intended for lung CT scans and liver MR and CT scans and runs on the Arterys Medical Imaging Cloud AI platform.
Amgen has been advised that the FDA's Oncologic Drugs Advisory Committee will review its supplemental biologics license application March 7 for its product Blincyto, or blinatumomab, for use in patients with minimal residual disease-positive B-cell precursor acute lymphoblastic leukemia, while a target action date of March 29 has been set for the sBLA.