The FDA said yesterday that it will be participating in two “collaborative communities,” joining the National Evaluation System for Health Technology Coordinating Center collaborative community (NESTcc) and the Ophthalmic Imaging collaborative community. The collaborative communities, convened by interest stakeholders, are for private and public sector members, including the FDA, to work together on medical device […]
TAVR technique cuts pacemaker implantation rate
According to a new study, a new approach to self-expanding transcatheter aortic valve replacement could minimize the risk of permanent pacemaker implantation. The patient-specific approach was used in analyzing nearly 250 patients with severe aortic stenosis who underwent TAVR to look at factors contributing to PPMI, according to Medscape. The study was published by lead […]
Ambrosia app links Abbott’s FreeStyle Libre with Fitbit wearable
Ambrosia Systems said today that it launched its LinkBlueCon application on the Fitbit and Abbott (NYSE:ABT) FreeStyle Libre smartwatch platforms for glucose monitoring. San Fransisco-based Ambrosia’s LinkBlueCon app is designed to monitor glucose levels and receive notifications when glucose readings are outside the target range, all without the need to go to a clinic. Ambrosia said […]
Synchron touts first-in-human implantation for brain-computer interface
Synchron said today that it completed the first successful clinical implantation of the Stentrode neural interface technology designed to restore communication in people with severe paralysis. The Campbell, Calif.-based company said the minimally invasive neural interface technology, as part of the Synchron brain-computer interface, is in its first clinical feasibility trial. The Stentrode is an […]
Zimmer Biomet, Align Technology ink distribution deal
Zimmer Biomet (NYSE:ZBH) said yesterday that it entered into a multinational distribution deal with Align Technology (NSDQ:ALGN) for its iTero Element family of intraoral scanners. The companies did not disclose the terms of the agreement, but said the partnership has a goal of delivering multiple digital workflows for dental professionals and laboratories, enabling business-to-business collaboration and offering […]
Integra Lifesciences touts Cadence ankle study
Integra LifeSciences (NSDQ:IART) yesterday touted positive findings from its Cadence total ankle system retrospective study and closed enrollment ahead of schedule for two post-market studies of the device. The study reported that patients treated with Cadence while suffering from end-stage arthritis experienced improvements in quality of life, functional measures and pain. The results were presented during […]
Active Implants wins breakthrough nod for NUsurface knee implant
Active Implants said yesterday that it won breakthrough device designation from the FDA for its NUsurface meniscus implant, the first of its kind to be marketed in Europe and, if cleared by the FDA, the first artificial meniscus in the U.S. Memphis-based Active Implants’ NUsurface implant is an investigational treatment for patients suffering from persistent […]
Tandem Diabetes Care touts real-world t:slim X2 insulin pump data
Tandem Diabetes Care (NSDQ:TNDM) yesterday touted real-world data from users of the t:slim X2 insulin pump. The data, from more than 8,000 users, was published in the medical journal Diabetes Technology & Therapeutics. San Diego-based Tandem said the study showed a 45% relative risk reduction in hypoglycemia and a 71% relative risk reduction in hypoglycemic events, […]
FDA clears Viseon’s Voyant spine surgery imaging device
Viseon said today that it won FDA clearance for its Voyant system for integrating minimally invasive surgical access with high-definition imaging technology. Irvine, Calif.-based Viseon’s Voyant technology is billed as an alternative to surgical microscopes, endoscopes and loupes, designed for use in both posterior and lateral-access minimally invasive spine procedures. With real-time, high-definition imaging technology, […]
Covalon closes $6m private placement
Covalon Technologies (TSXV:COV.V) said yesterday that it closed a private placement worth nearly $6 million. Mississauga, Ontario-based Covalon initially priced the offering at about $6.3 million, but re-priced it to approximately $5.5 million earlier this month to reflect the market for its stock. The revised offering, of nearly 2.8 million units (one share and one warrant) […]
Pulmatrix doses first patient in Pulmazole trial
Pulmatrix (NSDQ:PULM) said yesterday that it dosed the first patient in its Phase II trial of Pulmazole for the treatment of allergic bronchopulmonary aspergillosis asthmatics. The 64-patient study is a randomized, double-blinded, placebo-controlled trial to evaluate the safety and efficacy of three dose levels of the anti-fungal drug itraconazole formulation Pulmazole. The multi-center, four-arm trial will […]