A duo of House Energy & Commerce Committee Republicans announced this week that they plan to take a closer look at the FDA’s life sciences initiatives, suggesting that the agency may need an advisory panel to watch its performance.
Regulatory/Compliance
FDA | Recalls | 510(k) | Pre-Market Approvals | MDSAP | Clinical Trials
FLASH: FDA panel votes 5-3 that benefits of Abbott’s MitraClip heart implant outweigh the risks
The FDA’s Circulatory System Devices Panel voted today to make its recommendation regarding Abbott’s (NYSE:ABT) premarket approval application for the MitraClip heart implant, agreeing unanimously that the device is safe but issuing a mixed result on the effectiveness and potential risks of the device.
Report: Medtronic may offer $3B in bonds in 2013 | MassDevice.com On Call
FDA puts highest-risk category on Symbios infusion pump recall
Symbios Medical Products recalled certain lots of its GOPump Elastomeric Infusion PumpKit systems over concerns that a component that moderates the flow of medicine from the pump may fail and cause an overdose.
The FDA placed Class I status on the recall, a category reserved for issues which "may cause serious adverse health consequences, including death," according to an agency notice.
It’s time for a national patient identifier
FDA blames poor training for new deaths, injuries tied to Stryker’s recalled Neptune systems
FDA inspectors warn NuVasive on marketing for Affix spinal implants
Federal regulators warned NuVasive (NSDQ:NUVA) this month about certain promotional claims made in connection with the company’s spinal products.
The FDA in October 2012 inspected NuVasive’s San Diego, Calif., manufacturing facility, finding only the single violation regarding marketing language for the company’s Affix Spinous Process Plate System.
FDA says it won’t recommend approval for Abbott’s MitraClip implant
Correction: March 20, 2013, at 11:40 a.m.: This article mistakenly stated that the FDA’s advisory panel recommended against approval for MitraClip. The recommendation came from the FDA’s internal reviewers prior to the panel meeting.
U.S. lawmakers plan hearings on medical app regulation
By Stewart Eisenhart, Emergo Group
The US House of Representatives ‘ Energy and Commerce committee will hold hearings over three days in mid March regarding the Food and Drug Administration’s approach to regulating mobile medical applications and telehealth products.
Allergan lands a date with the FDA | MassDevice.com On Call
MASSDEVICE ON CALL — Aesthetic medical device maker Allergan (NYSE:AGN) will get a date with the FDA to review clinical data for the company’s Juv[eacute]derm Voluma XC dermal filler.
Allergan hopes to win indication for deep implantation for aesthetic restoration in the face, according to the FDA notice.
Syncardia nabs 2 Humanitarian Use Device wins for its smaller artificial heart
SynCardia Systems won 2 new Humanitarian Use Device designations for its 50cc Total Artificial Heart as a cardiac bridge transplant device.
The new HUD designations apply to use with children, smaller women and other people with small stature. The Tuscon, Ariz.-based device manufacturer designed this device as a smaller version of its 70cc temporary Total Artificial Heart, approved in 2004, according to a press release.