Bioventus said today that its Durolane single-injection, hyaluronic acid product won FDA approval for the treatment of pain associated with knee osteoarthritis. When a person develops osteoarthritis in their knee, the cartilage breaks down and so does the synovial fluid that provides lubrication to joint tissues. Hyaluronic acid provides cushioning and lubrication to the knee, […]
Food & Drug Administration (FDA)
Bioventus wins FDA nod for Durolane OA joint lubrication product
Bioventus said today it won FDA approval for its Durolane injectable product designed for joint lubrication and treating pain associated with knee osteoarthritis. Durolane is a single-injection, hyaluornic acid product designed to lubricate joints to treat pain associated with knee osteoarthritis, Durham, N.C.-based Bioventus said. The company acquired it last December from Galderma for an undisclosed amount. […]
Sanofi wins tentative FDA nod for Admelog insulin lispro injection
Sanofi (NYSE:SNY) said today that the FDA granted the company tentative approval for its Admelog insulin lispro injection. The decision is based on physicochemical, non-clinical and clinical similarity to another, already-approved insulin lispro injection. The compound is contraindicated during hypoglycemia episodes and in patients with hypersensitivity to insulin lispro or one of its other ingredients, Sanofi […]
How to work with the new FDA
Here’s how medical device makers can capitalize on the strategic priorities and transparency initiatives at FDA’s CDRH. Lisa Olson, RCRI Scott Gottlieb has now settled into his role as FDA’s new commissioner and is putting his stamp on the agency. Interestingly, he has started with some very specific points of focus that have bubbled to […]
Adherium wins 510(k) clearance for smart inhaler monitoring device
Adherium Ltd. (ASK:ADR) said today that it won 510(k) approval from the FDA for its inhaler monitoring device, SmartTouch for Symbicort. The device was cleared for use with AstraZeneca‘s (NYSE:AZN) Symbicort aerosol inhaler. The Melbourne, Australia-based company’s product installs directly onto a patient’s inhaler to monitor and boost medication adherence. Get the full story at our sister […]
CSA Medical wins another FDA expansion for TruFreeze cryotherapy
Endoscopic cryo-ablation company CSA Medical said today it won expanded FDA 510(k) clearance for its TruFreeze spray cryotherapy system, now cleared for use on patients with Barrett’s esophagus with low grade dysplasia. With the clearance, the device is now approved for both low and high grade dysplasia as well as malignancies, the Boston-based company said. “Over the […]
Dextera Surgical wins expanded FDA nod for MicroCutter 5/80 stapler
Dextera Surgical (NSDQ:DXTR) said today it won expanded FDA 510(k) clearance for its MicroCutter 5/80 stapler and associated reloads, now cleared for open solid organ parenchymal dissection techniques. The new clearance covers use on organs including the liver, kidney, pancreas and spleen, the Redwood City, Calif.-based company said. “The small size and large degree of articulation […]
SteadyMed shares tumble after FDA refuses to review Trevyent NDA
Shares in SteadyMed (NSDQ:STDY) fell more than -35% today after the company announced that the FDA will not review the new drug application for its drug-device combo product, Trevyent. The company received a refused to file letter, indicating that its NDA is incomplete and that the regulatory agency will not look it over. This is the […]
Smiths Medical wins 510(k) approval for wireless ambulatory infusion pump
Smiths Medical said yesterday that it won 510(k) clearance from the FDA for its CADD-Solis wireless ambulatory infusion pump. The device can connect wirelessly with Smiths’ PharmGuard Server infusion management software, enabling clinicians to deploy updates and drug libraries to all pumps simultaneously, as well as remotely manage device performance and monitor drug dosing. Get the […]
FDA clears Danaher’s Leica Microsystem’s FL560 cerebrovascular fluorescence microscope filter
Danaher‘s (NYSE:DHR) Leica Microsystems said yesterday it won FDA 510(k) clearance for its FL560 fluorescence microscope filter designed for visualizing cerebrovascular blood flow when used in conjunction with dye fluorescein. The filter is designed to be integrated into a M530 OH6 neurosurgical microscope to provide real-time, high-contrast visualization of cerebral anatomy in native color and […]
Exthera Medical wins FDA EAP designation for Seraph 100 blood filter
Exthera Medical said today that the FDA granted its Seraph 100 blood filter an expedited access pathway designation. The approval comes with an initial indication for use “as an adjunctive treatment for bacteremia in addition to antibiotics for patients receiving hemodialysis when the source of the infection is heparin- or heparin sulfate-binding bacteria, including antibiotic […]