From Attune Medical receiving FDA 510(k) clearance to Synapse Medical having CE Mark approval, here are 5 medtech stories we missed this week but thought were still worth mentioning. 1. Attune Medical gets FDA 510(k) clearance Attune Medical announced in a Jan. 8 press release that it has received FDA 510(k) clearance for its EnsoETM […]
Regulatory/Compliance
FDA | Recalls | 510(k) | Pre-Market Approvals | MDSAP | Clinical Trials
EMA committee backs label change for GSK’s Relvar Ellipta asthma therapy
GlaxoSmithKline (NYSE:GSK) and Innoviva (NSDQ:INVA) said today that a European Medicines Agency committee has backed an updated label for its once-daily asthma therapy, Relvar Ellipta. If granted marketing authorization by the European Commission, the combination drug treatment will be approved for use in patients whose asthma is already controlled on an inhaled corticosteroid and a long-acting beta-2-agonist. Get […]
Hitachi wins FDA nod for proton beam therapy real time image gating system
Hitachi (NYSE:HIT) said this week it won FDA 510(k) clearance for its Real Time Image Gating System designed for use with its proton beam therapy systems. Real Time Image Gating Proton Beam Therapy is designed to track and irradiate tumors in motion, using a 2mm diameter gold marker close to the tumor to establish its […]
Ocular Therapeutix plans $32.5m public offering to fund NDA resubmission for Dextenza
Updated to include the offering’s pricing information. Ocular Therapeutix (NSDQ:OCUL) said today that it plans to launch an underwritten public offering of 6.5 million shares of common stock at $5.00 apiece to help fund the resubmission of its new drug application for Dextenza, an ocular post-surgical pain-relief implant that was rejected by the FDA last year. The Bedford, Mass.-based […]
AngioDynamics wins FDA fast track for NanoKnife
AngioDynamics (NSDQ:ANGO) yesterday said the FDA granted a fast-track designation for its NanoKnife device for treating Stage III pancreatic cancer. The federal safety watchdog’s Expedited Access Pathway is designed to speed medical devices through the approval process to treat conditions with no available alternatives. The EAP program will transition to the Breakthrough Devices Program once the […]
FDA, FTC warn companies over deceptive opioid cessation products
The FDA and the Federal Trade Commission have posted joint warning letters to companies that make and distribute opioid cessation products. The two watchdogs warned that the companies are illegally marketing their unapproved products as treatments or even cures for people with opioid addiction and withdrawal. Selling unapproved products as therapies for opioid addiction is […]
Boston Scientific puts $90m into Millepede
Boston Scientific (NYSE:BSX) said today that it took out a $90 million position in Millepede that includes an option to buy the heart valve repair firm. Santa Rosa, Calif.-based Millipede makes the Iris transcatheter annuloplasty ring for treating mitral valve regurgitation. Marlborough, Mass.-based Boston Scientific can trigger the option to acquire the rest of Millipede any time […]
IlluminOss Medical wins de novo nod from FDA for bone stabilization system
The FDA last month granted de novo clearance to the photodynamic bone stabilization system developed by IlluminOss Medical. The IlluminOss device uses a light-curable polymer, delivered in an expandable balloon catheter, to stabilize bone fractures. In a Dec. 19 letter to the East Providence, R.I.-based company, the FDA granted de novo clearance for an indication for […]
Pulmatrix wins EU nod for inhaled dry-powder anti-fungal trial
The UK Medicines and Healthcare Products Regulatory Agency has given Pulmatrix (NSDQ:PULM) the go-ahead to launch its first-in-human study for an inhaled formulation of the anti-fungal drug, itraconazole. The company is evaluating its drug, Pulmazole, as a treatment for allergic bronchopulmonary aspergillosis in patients with asthma. Get the full story at our sister site, Drug Delivery Business […]
Topcon’s ocular diagnostic instrument lands 510(k) clearance
Topcon Medical Systems said today that its DRI OCT Triton Series system won 510(k) clearance from the FDA. The company’s ocular diagnostic instrument features a built-in retinal camera, eye-tracking and a 1 micron, 1050 nm light source with a scanning speed of 100,000 A-scans/second. Topcon’s touted its system as being able to quickly penetrate ocular […]
Adhesys Medical wins CE Mark for Flix surgical adhesive
The owner of Germany’s Adhesys Medical said last week that it won CE Mark approval in the European Union for its Flix topical skin adhesive for surgery. Grünenthal, which in May 2016 inked a distribution deal with Adhesys, said it acquired Adhesys outright in April 2017. An internal surgical sealant based on the same polyurethane-based technology is […]