Just last week, OptiScan Biomedical announced that its OptiScanner 5000 glucose monitoring system won 510(k) clearance for use in surgical intensive care units. The regulatory win was supported by eight rigorous clinical trials, CEO Peter Rule told Drug Delivery Business News, and represents a victory for a technology that the company hopes to expand into a platform system. Get the […]
Regulatory/Compliance
FDA | Recalls | 510(k) | Pre-Market Approvals | MDSAP | Clinical Trials
Abbott wins FDA nod for Confirm Rx smartphone-connected cardiac monitor
Abbott (NYSE:ABT) said today it won FDA clearance for its Confirm Rx insertable cardiac monitor, touting it as the 1st and only smartphone compatible ICM designed to help identify cardiac arrhythmias. The Confirm Rx system includes a sensor designed to be implanted just under the skin over the chest in a minimally-invasive outpatient procedure, the company said. […]
United Therapeutics wins FDA nod for third-gen Tyvaso TD-300/A nebulizer
United Therapeutics (NSDQ:UTHR) said today that its third-generation inhalation device designed for use with its Tyvaso treprostinil inhalation solution won FDA approval. Tyvaso first won FDA approval in 2009 as a treatment for pulmonary arterial hypertension, the company said, with an ultrasonic nebulizer. United Therapeutics touted its drug-device combo as the most-prescribed inhalation therapy for PAD […]
FDA clears AstraZeneca’s once-weekly Type II diabetes drug-device combo
AstraZeneca (NYSE:AZN) said today that the FDA approved its once-weekly exenatide drug in a single-dose auto-injector for adults with Type II diabetes whose blood sugar is uncontrolled on one or more oral drugs. The company’s drug, Bydureon, is formulated with a continuous-release microsphere delivery system designed to provide consistent levels of exenatide, according to AstraZeneca, to […]
Gottlieb updates on Puerto Rico med device manufacturing recovery
In the weeks following Hurricanes Irma and Maria, the people and leadership in Puerto Rico have been working to rebuild the island’s infrastructure. The FDA, which has been working with federal and local agencies, today provided an update to its efforts to help medical device manufacturers prevent potential shortages of medical devices like insulin pumps […]
7 medtech stories we missed this week: Oct. 20, 2017
From InspireMD’s distribution deal to RenalGuard touting a new study, here are seven medtech stories we missed this week but thought were still worth a mention. 1. InspireMD inks Chile distribution deal InspireMD announced in an Oct. 12 press release that it has signed a distribution deal with CorpMedical Chile to distribute the MGuard Prime […]
Meet the two former Johns Hopkins residents disrupting the wound care market
Ned Swanson and Denver Lough were plastic surgery residents at Johns Hopkins when they made a choice that would change the course of their lives – they decided to drop out and start a business. Lough had a technology that they thought could help patients if it ever made it to the market, but their […]
Kite wins FDA approval for first adult CAR-T cell therapy
More than a month before it was due to make a decision, the FDA yesterday approved a CAR-T cell therapy from Kite Pharma (NSDQ:KITE) – the first of its kind for adults. The therapy, which is made from a patient’s own cells, is designed to treat adults with non-Hodgkin lymphoma who have failed at least two other […]
FDA committee backs Novo Nordisk’s once-weekly type II diabetes drug
An FDA advisory committee has voted favorably to approve Novo Nordisk‘s (NYSE:NVO) once-weekly semaglutide Type II diabetes drug. Shares in the insulin maker were up 2% in after-hours activity today, trading at $50.13 apiece. Get the full story at our sister site, Drug Delivery Business News.
FDA warns craniofacial implant maker, dialysate producer
The FDA this week released warning letters it sent to 2 medical device manufacturers in response to letters related to previous inspections at craniofacial implant maker Kelyniam Global and dialysate maker Diasol. The federal watchdog said it was responding to a letter it received from Director Dr. Mark Smith at Kelyniam in June after having […]
DarioHealth wins CE Mark for glucose meter that connects to iPhone 7, 8 devices
DarioHealth (NSDQ:DRIO) said today that it won CE Mark approval for the version of its Dario blood glucose monitoring system that fits with the Lightning connector on Apple’s iPhone 7 and iPhone 8 smart phones. With this regulatory win, DarioHealth’s smart glucose meter can be used with a 3.5 mm headphone jack or Lightning connector, the […]