Strata Skin Sciences (NSDQ:SSKN) said this week it received a response letter from the FDA concerning possible 510(k) clearance paths for its Optimal Dosing Technology initially designed for treating psoriasis, vitiligo and other skin conditions. The Horsham, Penn.-based said the federal watchdog proposed 2 alternative paths, the 1st of which would require a clinical trial to […]
Regulatory/Compliance
FDA | Recalls | 510(k) | Pre-Market Approvals | MDSAP | Clinical Trials
GE Healthcare wins FDA nod for mammography system with patient controlled compression
GE Healthcare (NYSE:GE) said yesterday it won FDA 510(k) clearance for its Senographe Pristina Dueta, which it claims is the 1st patient-assisted mammography device that allows women to control their own compression during the examination. With the system, the woman undergoing the exam can control the application of compression on their breasts to minimize perceived pain […]
NuVasive wins FDA nod for redesigned Magec system
NuVasive Inc. (NSDQ:NUVA) said today it won FDA 510(k) clearance for its redesigned Magec magnetically controlled growth modulation system. The San Diego, Calif.-based company’s Magec system uses magnetic technology and adjustable growth rods to treat early-onset scoliosis, and features the company’s Reline small stature system. The Reline small stature platform is a pediatric deformity fixation system which […]
Janssen’s respiratory panel wins 510(k) clearance
Johnson & Johnson (NYSE:JNJ) subsidiary Janssen Diagnostics said today that it won 510(k) clearance from the FDA for its Idylla respiratory panel. The diagnostic test, developed in partnership with Biocartis Group, helps physicians identify viral respiratory infections, including infection from respiratory syncytial virus and influenza virus. Get the full story at our sister site, Drug Delivery […]
Bioventus wins FDA nod for knee osteoarthritis pain injection
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, […]
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 […]
China wants to dominate medtech: Here’s how
Under its “Made in China 2025” plan, the Chinese government seeks explosive growth in biomedical and high-end medical device manufacturing. Grace Fu Palma, China Med Device In 2015, the China State Council issued a 10-year manufacturing plan called “Made in China 2025.” The goal is to elevate the “giant but weak” Chinese manufacturing industry into […]
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 […]