Dental devices maker Biolase (NSDQ:BIOL) touted FDA clearance for its EPIC 10S soft tissue diode laser, which the company can now market for more than 80 indications spanning 19 medical markets.
Regulatory/Compliance
FDA | Recalls | 510(k) | Pre-Market Approvals | MDSAP | Clinical Trials
Stryker’s knee surgery device recall gets FDA’s highest-risk label
New HHS budget proposal would add $821M to FDA’s coffers
The 2014 budget proposal for the Dept. of Health & Human Services contains some important boosts in the FDA’s coffers, including a $59 million increase the agency’s medical device review arm compared with 2012.
The new budget would provide the Dept. of Health & Human Services a total of $967.3 billion in outlays and $80.1 billion in discretionary spending, and it includes initiatives that aim to save $361.1 billion over a decade.
FDA accepts Edap’s Ablatherm PMA application
Edap (NSDQ:EDAP) said the FDA accepted its pre-market approval application for its Ablatherm ultrasound prostate cancer treatment, backed by data from its Enlight investigational device exemption study.
The Vaulx-en-Velin, France-based medical device company also reported that its losses increased by a whopping 646% during the 2012, on an 8% sales increase.
Calgary Scientific’s ResolutionMD Android imaging app wins FDA nod
Calgary Scientific won 510(k) clearance from the FDA for its ResolutionMD app for Androids smartphones.
The app is designed to allow physicians to diagnose medical images on their Android phones.
Calgary won an FDA nod in 2011 for the iPhone- and iPad-compatible versions of the app.
FDA OKs a new iPhone prescription vision test | MassDevice.com On Call
MASSDEVICE ON CALL — U.S. healthcare regulators granted 510(k) clearance to Vital Art & Science’s myVisionTrack prescription iPhone vision test.
The test, which uses a test called shape discrimination hyperacuity to evaluate vision, is designed to monitor and record vision in patients with serious degenerative eye conditions.
FDA panel recommends approval, questions benefits of Bausch + Lomb eye implant
An FDA advisory panel agreed on April 8 to recommend approval of Bausch + Lomb’s 1st-of-its-kind intraocular lens for patients who have had a cataract removed and would like to, without glasses, have improved distance vision and reduced residual refractive cylinder.
FDA releases draft Sunshine Law guidelines
The FDA published a draft of its financial disclosure guidelines, due to take effect by August , that parallel the healthcare reform law’s Sunshine Act.
The 35-page document details all physician-relationship rules companies will have to follow when applying for marketing applications with the FDA.
FDA reschedules orthopedic panel meeting
The FDA rescheduled a meeting of its Orthopedic & Rehabilitation Devices Panel, originally slated for April 5, to discuss reclassifying shortwave diathermy devices and pedicle screws.
The shortwave diathermy meeting is now scheduled for May 21 in Gaithersburg, Md., the agency said.
BREAKING: FDA panel recommends approval for Bausch + Lomb’s Trulign Toric eye implant
An FDA advisory panel agreed today to recommend that the federal watchdog agency approve Bausch + Lomb’s first-of-a-kind intraocular lens for patients who have had a cataract removed and would like to, without glasses, have improved distance vision and reduced residual refractive cylinder.
The panel voted 10-0 with 2 abstentions that Bausch + Lomb proved the Trulign Toric posterior chamber intraocular lens is safe; 10-1 with 1 abstention that the device is effective; and 10-1 with 1 abstention that its benefits outweight its risks.
Allied Healthcare Group seeks 510(k) for its heart tissue patch
Allied Healthcare Group (ASX: AHZ) submitted its 510(k) application for FDA clearance of its CardioCel device, a tissue patch designed to repair heart deformities and malfunctioning valves.
The Australian medical device maker has the green-light in Australia for this product and is waiting to hear back about European CE Mark approval. The company is touting recent study data that shows no tissue calcification 4 years after the device is implanted.