Two US Senators this week wrote to Centers for Medicare and Medicaid head Seema Verma urging her to add a field for unique medical device identifier information on insurance claim forms. The letter, from Senators Elizabeth Warren (D-Mass) and Chuck Grassley (R-Iowa), cited a report from the Department of Health and Human Services’ Office of […]
Regulatory/Compliance
FDA | Recalls | 510(k) | Pre-Market Approvals | MDSAP | Clinical Trials
FDA chief to big pharma: ‘End the shenanigans’
FDA commissioner Dr. Scott Gottlieb yesterday scolded pharmaceutical companies that employ tactics to stifle generic drug competition, calling on them to “end the shenanigans.” At this week’s Federal Trade Commission meeting on competition within the pharmaceutical industry, the FDA chief called out brand-name pharma companies for trying to extend negotiations over risk evaluation and mitigation […]
FDA puts Second Sight Medical’s next-gen Orion ‘bionic eye’ on the fast track
Second Sight Medical (NSDQ:EYES) said today that the FDA put its Orion “bionic eye” on the fast track to approval. The Orion device is a cortical visual prosthesis that uses a camera and a brain implant to bypass the optic nerve in visually impaired patients. The federal safety watchdog put the device on its expedited […]
FDA approves Axonics IDE trial for r-SNM neuromod
Axonics Modulation Technologies said today it won FDA investigational device exemption clearance to engage in a pivotal study of its r-SNM rechargeable sacral neuromodulation system designed for treating overactive bladder and bowel dysfunction. The Irvine, Calif.-based company said it expects to begin enrolling patients in the clinical study in November, aiming to enlist 120 patients at […]
Report: Q3 medical device recalls down 39%
Medical device recalls have declined 39% for the third quarter, settling at 167, the lowest quarter the US has seen since the fourth quarter of 2011, according to a new Stericycle Expert Solutions report. Recalled units were up, however, rising 1% to 68 million which positioned it higher than 16 of the last 19 quarters, […]
Report: Proposed DoD health committee could undermine the FDA
A new defense policy bill would give the US Department of Defense the power to approve drugs and medical devices without FDA clearance, according to a report from Politico. The bill has alarmed congressional health staff and the Dept. of Health and Human Services who claim it could erode medical safety, putting US soldiers at […]
Boston Scientific recalls certain sizes of Eluvia, Innova stents
Boston Scientific (NYSE:BSX) has initiated a voluntary recall of its 150mm Eluvia drug-eluting vascular stent, as well as its 180mm and 200mm Innova self-expanding stent system, according to a documentfiled by the Federal Institute for Drugs and Medical Devices in Germany. The company said it was pulling these particular devices due to the number of complaints that […]
One Drop launches its diabetes tech in Canada after regulatory nod
One Drop announced today that its Bluetooth-enabled blood glucose monitoring system and mobile app are now available throughout Canada after landing approval from the country’s regulatory agency. The company’s portfolio of diabetes management technology is now available in the U.S., Canada, the E.U. and the United Kingdom. Get the full story at our sister site, Drug […]
FDA conducts pre-approval inspection for Intersect ENT’s Menlo Park facility
Intersect ENT (NSDQ:XENT) said today that the FDA performed a pre-approval inspection of the company’s Menlo Park facility as part of the new drug application for the its Sinuva steroid-releasing sinus implant. Although the FDA issued a form 483 with four inspection-related observations, the company said it doesn’t expect these notes to impact its Jan. 7 […]
Grifols wins FDA nod for fibrin sealant
Grifols (NSDQ:GRFS) said this week it won FDA approval for its Fibrin Sealant designed for surgical use in adults. The company said the newly cleared product is composed of the plasma proteins fibrinogen and human thrombin. Grifols said that the Fibrin Sealant will be manufactured at its Parts de Vallés facilities in Barcelona, Spain, according to an […]
Japan clears Abbott’s Mitraclip
Abbott (NYSE:ABT) said today it won approval from Japan’s Ministry of Health, Labour and Welfare for its MitraClip transcatheter mitral valve repair device, cleared for indications of treating people with mitral regurgitation. Currently, standard of care treatment for mitral regurgitation in Japan is limited to open-heart surgery and medication, Abbott said. Clearance of the catheter-based MitraClip […]