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Recall roundup: CareFusion infusion pump, J&J sedation device, Teleflex endobronchial tube

The FDA recently deemed corrective actions to three devices as Class 1, reserved for situations in which "there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death."

Insulet says troubled wearable insulin pump plant back on track, just as FDA issues recall notice

Insulet said its long-troubled Billerica, MA manufacturing plant is back on track on an earnings call earlier this month--just before the FDA offered details on the OmniPod recalls that were caused by inadequate standards compliance. In July, the company issued a voluntary recall of more than 400,000 OmniPod Insulin Management Systems, which are wearable insulin pumps.

 

Nerve repair micro-cap AxoGen nabs $17.5M from PE group to get to cash-flow positive

Private equity group Essex Woodlands has snapped up a 16% stake in surgical peripheral nerve solutions company AxoGen. The company raised $17.5 million to back its existing regenerative medicine products, as well as to develop new candidates for nerves severed during prostate cancer surgery and lower extremity nerve injuries. The financing is expected to put the company in the black for the first time.

 

Couple creates artificial pancreas, in latest win for diabetes' growing do-it-yourself movement

Engineer Scott Leibrand and diabetes patient Dana Lewis have created an artificial pancreas, via years of constant experimentation and iterative upgrades.

Abbott denies FT report that it's preparing $25B bid for St. Jude

News that Abbott is preparing a $25 billion bid for drugmaker St. Jude Medical hogged the headlines this morning, but in the latest twist, the drug and devicemaker just told Reuters it is not interested in St. Jude.

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FierceBiotech

Shire has been quiet since making its unwelcomed $30 billion bid to acquire Baxalta public earlier this month. But Baxalta evidently isn't waiting for the next step to play out in that dance. Bloomberg is reporting this afternoon that Baxalta is hunting for an acquisition around the $2 billion mark that would add to its hematology pipeline.

FiercePharma

It was attention-grabbing when California sued a handful of drugmakers, accusing them of lying about the safety of their high-powered painkillers and blaming them for an epidemic of prescription drug overdoses and a resurgence in heroin use. But from a legal standpoint, a California judge has ruled, there is not much there to stand on.