Boston Sci gains CE mark to revise stent treatment; Illumina's profit goes through the roof;

 @FierceMedDev: The FDA says it will focus more on quality in the device approval process. What that means may be an open question. More | Follow @FierceMedDev

 @MarkHFierce: A medical device regulatory scandal erupts in Great Britain. Report | Follow @MarkHFierce

 @DamianFierce: Thermo Fisher beats the Street again on soaring diagnostics sales. More | Follow @DamianFierce

> Boston Scientific ($BSX) gained a CE mark to add three-month dual anti-platelet therapy to the directions for its Promus Element and Promus Element Plus coronary stent systems. Story

> Illumina ($ILMN) reported a huge third-quarter boost, with net income jumping 50% to $30 million and revenue increasing 21% to $235 million. More

> Teleflex Medical ($TFX) closed its $276 million acquisition of LMA International, maker of airway-management devices used in anesthesia and emergency care. Item

> Siemens ($SI) has launched Micon, a new hearing aid platform it says has twice the processing power of the tech behind its last generation of devices. Release

> iWalk has launched a new power pack for its BiOM bionic ankle, increasing its battery life by 20%. News

> Elixir Medical says it has generated excellent three-year results regarding its CE mark-approved DESyne Novolimus Eluting coronary stent system. Item

> Researchers believe they've developed an intravaginal ring that can help prevent HIV transmission. Item

Biotech News

 @FierceBiotech: Industry Voices: Biosimilars and Trade Secrets. Feature | Follow @FierceBiotech

 @JohnCFierce: ZS Pharma down in Fort Worth raised $46M in venture funds for clinical trial of kidney, liver disease drug. | Follow @JohnCFierce

 @RyanMFierce: Radius has set its biotech IPO range $8.50-$10.50. Will it hit its price target and keep the streak alive? More | Follow @RyanMFierce

> Two Texas biotech outfits lasso venture deals totaling $81M. Article

> FDA smacks down United Therapeutics' oral hypertension drug. Report

> Report: J&J jettisons 130 jobs after PhIII Alzheimer's misfire. Story

Pharma News

@FiercePharma: More pain for Big Pharma sales: Lilly's drop 11%, earnings fall short. Not as bad as BMS, though. More | Follow @FiercePharma

> Pharma wheels and deals in Europe as austerity wears on. Story

> GOP or Dem? Some pharma donors don't hedge their bets. Article

> BMS results crater on 96% drop in Plavix sales. News

Drug Delivery News

> Fuse Science rolls out roll-on delivery. News

> Biotecnol and PolyTherics team up to develop drug conjugates. Story

> Antibiotic Trojan horse for cholera may be possible. Item

> Oral flu vaccine melts in your mouth. More

Biomarkers News

> Genes might not be the key to antidepressant success after all. Story

> Blood test could predict breast cancer 20 years early. More

> Blood antibody pinpoints deadly preeclampsia. Article

> Researchers seek new pancreatic cancer biomarkers. Item