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BioWorld - Wednesday, December 10, 2025
Home » Authors » Amanda Pedersen

Articles by Amanda Pedersen

Stellar RCT data spikes Spectranetics stock to 52-week high

Aug. 12, 2016
By Amanda Pedersen

Penumbra crushes 2Q16 with 53 percent growth, beating consensus on both revenue and EPS

Aug. 11, 2016
By Amanda Pedersen

New financing pumps $113M into Cvrx to support FDA approval of Barostim Neo

Aug. 10, 2016
By Amanda Pedersen
A private company using the brain to treat the heart has attracted $113 million in new financing to support a device that the FDA has designated for the expedited access pathway (EAP) program. Minneapolis-based Cvrx Inc. said $93 million of the new funding will come from a completed $57.7 million equity financing and another $35.3 million from the same investors that will be based on operational milestones. The other $20 million will come from a new $20 million debt facility.
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Luminex awarded EUA for Zika assay

Aug. 9, 2016
By Amanda Pedersen
Luminex Corp. has joined the U.S. battle against the Zika virus. The FDA gave Luminex, of Austin, Texas, emergency use authorization (EUA) for a multiplex nucleic acid test designed to detect Zika virus RNA in potentially infected patients using their blood serum, plasma, or urine (collected alongside a patient-matched serum or plasma specimen). The Xmap Multiflex Zika RNA assay was designed by the company's partner, Genarraytion Inc., of Rockville, Md.
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Transenterix remains focused on Alf-x, still hasn't given up on rejected Surgibot

Aug. 8, 2016
By Amanda Pedersen
Transenterix Inc. isn't giving up on the U.S. Surgical robotics market. During a Friday morning conference call to discuss the company's second quarter earnings – which included a $80.1 million net loss – executives said their focus is now on getting FDA approval for the Alf-x robot. But the company still plans to eventually seek approval for the Surgibot robot, which the FDA rejected earlier this year, noting that the device did not meet the criteria for substantial equivalence based on the company's submitted data.
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Oticon uses pupil size to develop new hearing devices and measure brain strain

Aug. 4, 2016
By Amanda Pedersen

Dextera and Intuitive 'staple' together plans to integrate Microcutter system into robot

Aug. 3, 2016
By Amanda Pedersen

MDD's Cardiology Extra

Aug. 2, 2016
By Amanda Pedersen

Regulatory pathway appears promising for Nova, Intersect's third sinus implant

Aug. 2, 2016
By Amanda Pedersen

Profits down and litigation charges loom, but BSX Q2 sales surpass analyst expectations

Aug. 1, 2016
By Amanda Pedersen
Litigation charges weighed on Boston Scientific Corp.'s second quarter profits, but analysts seemed so impressed with the company's better-than-expected sales and 10 percent organic sales growth they barely mentioned the $207 million (15 cents a share) net loss in their reports. A year earlier, Boston Scientific posted a profit of $102 million (8 cents a share).
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