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BSX

Boston Scientific

$38.11

0.3 (0.79%)

11:55
04/16/19
04/16
11:55
04/16/19
11:55

Boston Scientific, Coloplast ordered to stop sale of transvaginal mesh in U.S.

The U.S. Food and Drug Administration announced that it has ordered the manufacturers of all remaining surgical mesh products indicated for the transvaginal repair of pelvic organ prolapse to stop selling and distributing their products in the U.S. immediately. "The order is the latest in a series of escalating safety actions related to protecting the health of the thousands of women each year who undergo surgery transvaginally to repair POP," the FDA said. The FDA has determined that the manufacturers, Boston Scientific and Coloplast, have not demonstrated a reasonable assurance of safety and effectiveness for these devices, which is the premarket review standard that now applies to them since the agency reclassified them in class III in 2016. As part of the 2016 reclassification, manufacturers were required to submit and obtain approval of premarket approval applications, the agency's most stringent device review pathway, in order to continue marketing their devices in the U.S. The companies will have 10 days to submit their plan to withdraw these products from the market, the FDA said. Reference Link

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BSX Boston Scientific
$38.11

0.3 (0.79%)

03/18/19
PIPR
03/18/19
NO CHANGE
PIPR
Piper sees minimal impact from FDA review of paclitaxel coated devices
The FDA on Friday afternoon updated healthcare providers on its review of paclitaxel coated devices, which include Medtronic's (MDT) IN.PACT DCB and Boston Scientific's (BSX) Eluvia DES, Piper Jaffray analyst Matt O'Brien tells investors in a research note. In their pooled post-approval analysis, the FDA found ~50% increased risk of crude mortality compared to control devices and will be convening a panel to analyze this issue further, adds the analyst. He points out that the FDA is also recommending providers monitor patients who have received the devices and encouraging these providers to consider alternatives where the risks may outweigh the benefits. While this data is concerning, the result is "unsurprising given that many of these patients were included in the meta-analysis," contends O'Brien. Further, experts at the ISET 2019 conference in January were unconvinced about this connection to mortality, and a poll of the several hundred interventionists in the room indicated that it is unlikely to dampen usage in the interim, he says. As such, the analyst expects the FDA impact to have a minimal impact.
03/18/19
ADAM
03/18/19
NO CHANGE
Target $215
ADAM
Buy
Edwards Lifesciences price target raised to $215 from $190 at Canaccord
Canaccord analyst Jason Mills maintained a Buy rating on Edwards Lifesciences (EW) and raised his price target to $215 from $190 after the PARTNER 3 trial delivered superiority to surgery. In a research note to investors, Mills says he thinks the data will give Edwards a definitive marketing advantage in the TAVRmarket, relative to both Medtronic (MDT) and Boston Scientific (BSX), he thinks now has a higher hurdle to clear in TAVR than pre-Phase 3 data release.
03/27/19
UBSW
03/27/19
NO CHANGE
Target $46
UBSW
Buy
Boston Scientific underperformance due to paclitaxel concerns overdone, says UBS
UBS analyst Matthew Taylor kept his Buy rating and $46 price target on Boston Scientific after meeting with its management, saying the tone of the discussions was "bullish". The analyst is positive on the company's "balanced portfolio with category leadership in most of its businesses", and also believes that its recent underperformance attributed to paclitaxel concerns are overdone. Taylor further notes that Boston Scientific stock offers "compelling value and a good entry point given a myriad of catalysts to offset near-term headwinds."
04/11/19
PIPR
04/11/19
NO CHANGE
PIPR
Piper sees Nuvectra, Boston Scientific as winners in spinal cord stimulation
After surveying 37 clinicians on the present and future treatment of low back pain, Piper Jaffray analyst Matt O'Brien believes the spinal cord stimulation market is poised to continue "growing quickly." While the survey indicated Nevro (NVRO) and Nuvectra (NVTR) would pick up market share this year, O'Brien believes Boston Scientific (BSX) and Nuvectra will be the "primary share-gainers."

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BA

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BA

Boeing

$380.02

2.48 (0.66%)

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MSM

MSC Industrial

$83.37

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PINS

Pinterest

$24.46

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HUM

Humana

$240.65

7.645 (3.28%)

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Cigna

$148.95

3.46 (2.38%)

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$240.65

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CI

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TSLA

Tesla

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AMD

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$27.68

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SAM

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$266.90

0.89 (0.33%)

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MSM

MSC Industrial

$83.37

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KFS

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$2.30

-0.14 (-5.74%)

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AWK

American Water

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2.32 (2.27%)

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FSNN

Fusion

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0.0048 (2.01%)

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PSA

Public Storage

$217.43

0.81 (0.37%)

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V

Visa

$160.14

-0.33 (-0.21%)

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NAVB

Navidea

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TISA

Top Image Systems

$0.84

-0.0069 (-0.81%)

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FCPT

Four Corners Property Trust

$28.17

0.49 (1.77%)

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