Medtronic wins FDA nod for stent graft; Japanese TAVI market set to boom;

@FierceMedDev: GE snags ultrasound repair business. More | Follow @FierceMedDev

 @DamianFierce: As GSK trumpets two new FDA approvals, France's bioMérieux is poised to cash in on companion diagnostics. More | Follow @DamianFierce

@MichaelGFierce: Devicemakers balk at FDA's recall guidelines. Item | Follow @MichaelGFierce

> Australian medical device outfit Uscom is buying New Zealand's Pulsecor in exchange for 5 million shares, acquiring the company's BP Plus cardiovascular diagnostic system. News

> Theranostics Health and med fusion are planning to launch their TheraLink assays for breast cancer at this weekend's American Society of Clinical Oncology annual meeting. Story

> Breathe Technologies won FDA clearance for its Sleep System, designed to treat obstructive sleep apnea. More

> Japan could be key for devicemakers looking to profit off of transcatheter aortic valves, led by Edwards Lifesciences ($EW), and Millennium Research Group predicts a rapid adoption of the implants once they hit the market this year. Report

> Boston Scientific ($BSX) has joined the World Stroke Organization, aiming to raise awareness of treatments for atrial fibrillation and other causes of strokes. Item

> Medtronic ($MDT) won FDA approval for the Endurant II AUI stent graft system and 510(k) clearance for the Sentrant introducer sheath. News

> Invacare ($IVC) has amended its credit agreement, giving the company some flexibility as it works its way out from under an FDA warning letter concerning its wheelchair manufacturing. Release

Biotech News

@FierceBiotech: UCLA slams the door on GlaxoSmithKline's latest R&D competition. More | Follow @FierceBiotech

@JohnCFierce: ICYMI: Updated: GlaxoSmithKline gains FDA OK on two genetically targeted melanoma drugs. Report | Follow @JohnCFierce

@RyanMFierce: Biogen Idec appears to be playing the long game with delayed EU launch of Tecfidera, and that could benefit even short-term investors. | Follow @RyanMFierce

 @EmilyMFierce: Newest feature at @FierceBiotech: Top 10 experimental cancer drugs - 2013. Special Report | Follow @EmilyMFierce

> San Diego biotech files $23M IPO for gastroparesis PhIII. Report

> Pfizer taps UCSF for small-molecule drug discovery. Story

> ASCO presentations portend future shock of immunotherapy drug prices. Article

> Elan execs ready fallback plan as Royalty attacks 'jumble' of deals. News

Pharma News

@FiercePharma: UK cost watchdog about-faces on BMS and AZN's Forxiga, recommending it for some diabetes patients. Story | Follow @FiercePharma

@EricPFierce: Will Hospira never learn? FDA warning letter says some problems at India plant same as those recently noted at Rocky Mount. More | Follow @EricPFierce

@CarlyHFierce: ICYMI yesterday: FDA is importing TPN to ease drug shortage. Story | Follow @CarlyHFierce

> Continuing its manufacturing revamp, Pfizer unloads another Tennessee plant. Report

> Bristol-Myers, AstraZeneca win turnabout at NICE for Forxiga. More

> GlaxoSmithKline nabs key FDA approvals for two melanoma drugs. Article

> Ibuprofen carries heart attack, stroke risks on par with Vioxx's at high doses. News

Pharma Manufacturing News

> Pfizer sells King Pharma plant to UPM Pharmaceuticals. More

> UCB sells New York plant to Unither. News

> FDA turns to Fresenius to help relieve TPN shortage. Story

> New problems with Hospira's Indian plant reminiscent of Rocky Mount. Article

> J&J appeals OTC plant license revocation in India. Item

Vaccines News

> H7N9 shows resistance to Roche's Tamiflu. News

> Chinese HFMD vaccine impresses in Phase III. Report

> Gates-inspired gene therapy gives pandemic protection. Story

> Study links GSK's swine flu vaccine to narcolepsy in adults. Article

> Researchers seek fresh approach to HIV vaccine. More

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