Inari Medical said today it won FDA 510(k) clearance for its FlowTriever stent retriever designed to treat pulmonary embolisms. The clearance came based upon results from the company’s Flare clinical study of the device, which examined data from 106 patients with acute pulmonary embolisms treated with the FlowTriever at 18 US sites, the Irvine, Calif.-based company […]
Regulatory/Compliance
FDA | Recalls | 510(k) | Pre-Market Approvals | MDSAP | Clinical Trials
Varian stands on $1.28B offer for Sirtex
Varian Medical (NYSE:VAR) said today that it stands behind its initial $1.28 billion bid to acquire Sirtex Medical (ASX:SRX) in the wake of a $1.41 billion counter offer from China’s CDH Investments. The unsolicited bid from CDH Investments came in at a 20% premium on Varian’s A$28-per-share offer, prompting Sirtex to reconsider a merger that already has approval from U.S. antitrust […]
J&J’s Cerenovus wins FDA nod for Embotrap II revascularization device
Johnson & Johnson‘s (NYSE:JNJ) Cerenovus said today it won FDA 510(k) clearance for the Embotrap II revascularization device. The Irvine, Calif.-based J&J division said that the device is designed to quickly restore natural blood flow by retrieving emboli within the vasculature of the brain, using minimal compression to protect against further complications. Approval of the device came […]
Medtronic recalls select MindFrame Capture revascularization devices
The FDA today released a recall notice for a select number of Medtronic (NYSE:MDT) MindFrame Capture LP revascularization devices over issues with the delivery wire breaking or separating during use. The federal watchdog labeled the recall as a Class I, its most serious class of recall, which indicates the potential for serious injury or death. […]
GSK’s Arnuity Ellipta asthma therapy wins FDA nod for use in kids as young as 5 years old
GlaxoSmithKline (NYSE:GSK) won FDA approval for the use of its Arnuity Ellipta inhaler as a once-daily therapy for the maintenance treatment of asthma in children as young as five years old. The pharmaceutical company touted its regulatory win, pointing out that the fluticasone furoate treatment is one of the only once-daily asthma therapies cleared in the […]
Insightec seeks Parkinson’s indication in Japan for Exablate Neuro
Insightec said this week it submitted an application for pre-market approval to the Japanese Pharmaceuticals and Medical Devices Agency seeking an indication for its Exablate Neuro to treat advanced Parkinson’s Disease in patients suffering from mobility, rigidity or dyskinesia. The Israel-based company’s Exablate Neuro device uses high-intensity, focused ultrasound to thermally ablate targeted tissue, guided by continuous […]
InspireMD wins regulatory nod in Ecuador for CGuard, MGuard
InspireMD (NYSE:NSPR) said this week it won regulatory approval in Ecuador for its CGuard embolic prevention system and MGuard Prime devices. The approval comes shortly after the company inked an exclusive distribution agreement with Ecuadorian medical device distributor Cardiobene, Israel-based InspireMD said. Both companies have worked together to secure regulatory approvals in the country, InspireMD added. “We […]
Med-El wins FDA nod for Rondo 2 cochlear implant audio processor
Cochlear implant maker Med-El USA said today it won FDA approval for its Rondo 2 cochlear implant audio processor with an expected launch of the device this fall. The Durham, N.C.-based ocmpany said the newly cleared Rondo 2 audio processor features wireless charging capabilities that allow the device to fully recharge in four hours after being […]
Report: FDA exempts surgical facemasks from 510(k) requirements
The FDA finalized a rule this week exempting specific disposable respiratory protective masks from 510(k) requirements, according to a Regulatory Affairs Professionals Society report. The move was adopted in hopes of reducing regulatory burden on manufacturers of the surgical apparel devices and to eliminate the costs associated with regulatory clearance, according to the report. With […]
With groundbreaking approval, Amgen launches new class of medicine for migraine patients
Amgen (NSDQ:AMGN) won FDA approval this week for its once-monthly Aimovig injection designed to prevent the onset of migraines in adults. The drug is the first of its kind – a molecule that blocks the receptor for a protein that is linked to migraine pain, the calcitronin gene-related peptide. Other major pharmaceutical companies like Eli Lilly (NYSE:LLY) […]
FDA clears Additive Ortho’s patient specific 3D printed bone segments
Additive Orthopaedics said yesterday it won FDA 510(k) clearance for its Patient Specific 3D-printed bone segments. The 3D-printed segments are designed to address internal bone fixation in the ankle and foot, the Little Silver, N.J.-based company said. “This is a tremendous milestone for orthopaedics and the obvious trend towards patient specific 3D printed implants. In cases […]