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Home » Becton Dickinson lands clearance for 10-minute flu test | Regulatory Roundup

Becton Dickinson lands clearance for 10-minute flu test | Regulatory Roundup

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Becton Dickinson & Co. (NYSE:BDX) won FDA 510(k) clearance for its BD Veritor 10-minute diagnostic test for influenza A and B last month, amid rumors that the Franklin Lakes, N.J.-based company is ripe for buyout.

Veritor is the first rapid flu test with a digital readout, while older tests are slower, less accurate and more difficult to interpret, according to BD.

The digital readout precludes the need for a subjective analysis of the assay, and the system requires few steps and no sample incubation in advance.

The flu A+B assay is the first of many planned for the BD Veritor platform, according to a press release.

The news followed a particularly low point for the company after its valuation was at its lowest since 1993 after reporting dismal 3rd quarter earnings early in November, leading to speculation about a possible buyout.

Regulatory Roundup

Quidel also lands clearance for flu A+B test
Quidel Corp. (NSDQ:QDEL) received 510(k) clearance to market its for the sale of its Molecular Influenza A+B test in the U.S. Read more

Abiomed updates on progress toward Impella reimbursement
Abiomed (NSDQ:ABMD) updated investors on continued efforts to win current procedural terminology codes for purposes of physician payment for its Impella 2.5 heart pump. Read more

EnteroMedics completes enrollment for obesity device
EnteroMedics Inc. (NSDQ:ETRM) completed enrollment and device implantation for its ReCharge neuroblocking therapy as a treatment for obesity. Read more

Delcath’s Irish facility lands international safety certification
Delcath Systems Inc.’s (NSDQ:DCTH) Galway, Ireland, location won ISO 13485:2003 certification – an internationally recognized quality standard.   Read more

Verisante launches FDA clearance application for skin cancer detector
Verisante Technology Inc. initiated FDA clearance processes for its Aura skin cancer detection system. Read more

MindFrame lands CE Mark for Capture LP systems
MindFrame Inc. announced CE mark approval for a new series of its Capture LP devices, expanded to include a 4-mm diameter and shorter length sizes. Read more

Parvulus touts CE Mark for annuloplasty ring

Parvulus Suisse SA received a CE Mark for its Intra-annular Ring. Parvulus will launch the device on to the market immediately making the Ring available to cardiac surgeons from January 3rd 2012.
Read more

Magnetecs announces CE Mark win
Magnetecs Corp., a designer and manufacturer of robotic catheterization control systems for minimally invasive surgical procedures, announced that its Robotic Catheter Guidance Control & Imaging (CGCI) System won CE Mark approval. Read more

Sphere Medical wins CE Mark for blood analyzer

Sphere Medical won CE Mark for its Pelorus 1000 blood propofol measurement system, capable of rapidly measuring concentrations of the intravenous anaesthetic propofol in whole blood samples.
Read more

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