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 […]
Merit Medical closes $50m BrightWater buyout
BrightWater Medical said today that it completed the sale of the organization to Merit Medical (NSDQ:MMSI), three months after Merit made its $50 million offer. In June, Merit valued the acquisition at $35 million upfront with a further $15 million in potential payments contingent upon CE Mark approval and meeting future sales targets. Temecula, Calif.-based BrightWater’s […]
Astellas, Iota ink wireless implant pact
Iota Biosciences said last week that it has entered a research and development agreement with Astellas Pharma to explore new biosensing and treatment measures with wireless implantable medical devices. The deal will pair the companies up to design detailed specifications of the implantable devices and conduct preclinical studies for several diseases, according to a news release. […]
FDA clears OrthoSpin’s robot-assisted external fixation device
OrthoSpin has won FDA 510(k) clearance for its robot-assisted external fixation system for orthopedic treatments. Misgav, Israel-based OrthoSpin’s system is designed to automatically make pre-programmed adjustments to eliminate manual adjustments and patient training while reducing the need for follow-ups. The system could change the outcomes of orthopedic treatments such as bone lengthening, setting complex fractures […]
Signet Medical licenses melanoma sniffer tech
Signet Medical Solutions (OTC:SIGN) said today that it will license all rights to its non-invasive, vapor analysis system for detecting melanoma. The technology is designed to operate in real time, using vapor samples for painless diagnoses without time delays, according to parent company Signet International Holdings (Palm Beach, Fla.). Melanoma, along with other cancers, gives […]
Siemens Healthineers wins FDA nod for Artis Icono angiography line
Siemens Healthineers said yesterday that it won FDA clearance for its Artis Icono angiography systems for performing a wide range of minimally invasive procedures in a single interventional suite. The Artis Icono platform includes a biplane system engineered for neuroradiology and abdominal imaging, and a floor-mounted, single-plane system for vascular, interventional cardiology, surgical and oncology […]
FDA OKS Avita Medical trial for Recell in soft tissue reconstruction
Avita Medical (ASX:AVH) said yesterday that the FDA approved an investigational device exemption for a pivotal trial of its Recell autologous cell harvesting device. The Valencia, Calif.-based company said the 65-patient study is designed to compare conventional skin grafting with and without Recell system. Each patient is slated for a control wound treated with a conventional […]
