Category: Regulatory Roundup
Varian Medical Systems receives FDA clearance for its Pivitol Care Solution for prone breast treatment and to update its Clinac and Trilogy targeted radiotherapy devices.
Varian Medical Systems Inc. (NYSE:VAR) won FDA clearance to update the control software for its Clinac and Trilogy targeted radiotherapy devices and its new Pivitol Care Solution for prone breast treatment.
The software approval from the federal watchdog agency allows the Palo Alto, Calif.-based company's devices to deliver higher doses two times faster than previously possible at 2400 monitor units per minute.
Boston Scientific Corp. wins FDA approval for its Infinion 16 lead for use with its spinal-cord-stimulating pain management system.
Boston Scientific Corp. (NYSE:BSX) landed FDA clearance for its Infinion 16 percutaneous lead, designed for use with the company's Precision Plus spinal cord stimulator system to control chronic pain.
The Infinion 16 lead is the first 16-contact percutaneous lead on the global market, doubling the previous max of eight stimulating contacts, according to the Natick, Mass.-based med-tech titan.
Avedro wins a second orphan drug designation from the FDA for its VibeX ophthalmic solution.
Avedro Inc. won an orphan drug designation for a solution used with its KXL irradiation system to treat corneal ectasia following refractive surgery.
The decision sets the Waltham, Mass.-based company up for 7 years of exclusive rights to the U.S. market if the technology pans out.
The VibeX ophthalmic solution is used with the company's UVA radiation system for corneal cross-linking to treat corneal ectasia following refractive eye surgeries such as Lasik.
Covidien lands FDA clearance for its SpiderFX embolic protection device.
SpiderFX embolic protection device
Covidien (NYSE:COV) landed 510(k) clearance for its SpiderFX system to treat severely calcified lesions in the lower extremities.
The Mansfield, Mass.-based med-tech titan's system has been on the European market since 2005 and is currently the only embolic protection device indicated for use in the lower extremities in the U.S.
Philips wins FDA clearance to market its Ingenuity whole-body PET/MR imaging system in the U.S.
Philips Ingenuity Scanner
Philips Healthcare (NYSE:PHG) landed 510(k) clearance from the FDA to market its Ingenuity whole-body PET/MR imaging system in the U.S.
The scanner performs both PET and magnetic resonance imaging scans, allowing doctors to acquire images at a significantly lower radiation dose than traditional PET/computer tomography scanners, which use x-rays to make images.
Medtronic lands FDA clearance for the clinician-owned iPro2 Professional continuous glucose monitoring system.
Medtronic Inc. (NYSE:MDT) won FDA clearance for its next generation iPro2 Professional continuous glucose monitor.
The iPro2 Professional is a clinician-owned device that collects glucose data from a sensor inserted into a patient's skin.
The device tracks the patient's glucose levels for 3 days, collecting data as many as 288 times each day. The information may provide insight into how diet, medication and daily activities affect a patient's glucose levels.
BSD Medical Corp.
, CerMed International
, Dendreon Corp.
, FujiFilm SonoSite Inc.
, IntriCon Corp.
, Merz Aesthetics
, Neovasc Inc.
, Retina Implant AG
, STAAR Surgical Co.
, Translational Sciences Corp.
, Vascular Designs Inc.
Staar Surgical wins CE Mark approval for its NanoFLEX Toric intraoccular lenses.
Staar Surgical Co. (NASDAQ:STAA) landed CE Mark approval in the European Union for its nanoFLEX Toric IOL for use in cataract patients with astigmatism.
First shipments of the nanoFLEX intraocular lens are scheduled to roll out to the European market in the first quarter of 2012.