Medtronic Inc. (NYSE:MDT) launched two pacemakers that had been delayed by regulatory snafus for months, the company said today.
The Fridley, Minn.-based company resolved a Nov. 2009 warning letter that enabled the company to win FDA approval for the Consulta and Syncra cardiac resynchronization therapy-pacemaker (CRT-P) systems.
The two CRT-P devices had been under an “approvable letter,” meaning the FDA expected to approve the products once the company resolved manufacturing issues at its Mounds View, Minn., facility, a Medtronic spokeswoman confirmed to MassDevice. The company fixed the problems in early March.
Medtronic said the Consulta is the first CRT-P that includes the company’s OptiVol fluid status monitoring system, which is designed to identifies heart failure patients at risk for worsening symptoms before they develop. Both devices feature leadless ECG waveform output capabilities that allowing doctors to remotely monitor patients through a wireless system.
MDT shares were trading up about .5 percent to $38.43 by the late-afternoon.
Here’s a roundup of companies announcing clearances and approvals from the Food & Drug Administration and foreign regulatory agencies. Check out MassDevice’s compilation of the latest regulatory news for additional clearances and approvals.
- Elana wins FDA approval for cerebral bypass device
Dutch medical device manufacturer, Elana bv, announced that it has received approval from the Food & Drug Administration for a humanitarian device exemption (HDE), enabling a cerebral bypass. Elana bv is a corporate spin-off from the University Medical Centre Utrecht, the Netherlands.
- HeartWare wins Australian approval for ventricular assist device
HeartWare International Inc. (NSDQ:HTWR) wins approval from the Therapeutic Goods Administration (TGA) of Australia for the HeartWare Ventricular Assist System. The approval means the device will be listed on the Australian Register of Therapeutic Goods (ARTG).
- Hologic lands EUREF "Mammographic Type Test" certification for Selenia Dimensions
Hologic Inc.’s (NSDQ:HOLX) Selenia Dimensions digital mammography system in two dimensional (2D) mode has been awarded “EUREF Type Test” certification by the European Reference Organization (EUREF) Council for Quality Assured Breast Screening and Diagnostic Services. Only three products have received EUREF approval to date, of which two are Hologic systems, according to the company.
- Cynosure wins international marketing clearances for cellulite and laser lipolysis products
Two of Cynosure Inc.’s (NSDQ:CYNO) workstations for laser-assisted lipolysis and non-invasive cellulite reduction won international regulatory clearances. Health Canada issued a Medical Device License authorizing the sale in Canada of the company’s SmoothShapes XV system for the temporary reduction in the appearance of cellulite. The Korea Food and Drug Administration granted marketing approval to Cynosure’s Smartlipo Triplex, the company’s minimally invasive technology for fat removal and skin tightening.
- Merit Medical wins 510(k) clearance for the ASAP thrombus aspiration catheter
Merit Medical Systems Inc. (NSDQ:MMSI) received 510(k) clearance from the FDA for the company’s ASAP thrombus aspiration catheter. Merit manufactures disposable medical devices used in interventional and diagnostic procedures, particularly in cardiology, radiology and endoscopy.
- FDA grants 510(k) clearance to Life Technologies stem cell growth medium
Life Technologies Corp. (NSDQ:LIFE) landed FDA 510(k) clearance for StemPro MSC SFM – a first for this next-generation stem cell culture medium that is now cleared as a medical device and satisfies a requirement for researchers involved in clinical trials in the U.S., acccording to the company.
- Spaulding clinical nets 510(k) ECG device
Spaulding Clinical Research announced the 510(k) clearance for their proprietary ECG device platform, the Spaulding IQ. Spaulding developed the "IQ" to provide pharmaceutical clients a better and more efficient way to capture ECG data. Spaulding IQ is a handheld device with a single-button design and automation.