The failure of Medtronic's Symplicity 3 trial doesn't mean the end of renal denervation in treated resistant hypertension, especially in Europe, but future studies face a high bar set by the Medtronic trial's sham control arm.
Medtronic issues a warning letter to MiniMed Paradigm pump users after receiving reports that some patients had accidentally given themselves overdoses of insulin.
MASSDEVICE ON CALL — FDA medical device regulators reported this month that industry giant Medtronic (NYSE:MDT) issued a recall affecting nearly 560,000 units of its MiniMed Paradigm Infusion pumps.
Medtronic is not asking for the devices back, but is advising users to take extra care when programming their insulin dosage. The company has received reports that patients have accidentally programmed their insulin pumps to deliver the maximum bolus amount.
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The FDA report follows Medtronic's March 2014 letter to customers, in which the company cautioned users about accidental button pressing and advised that users always double-check their dosage on the pump's display.
Here's a look at some of the top legal news stories for medical device companies this week: ArthroCare ex-CEO faces 30-year sentence for fraud; Shareholders sue Edap following FDA slip; Ex-sales rep wins class action status in lawsuit against Stryker; Another Covidien shareholder sues over Medtronic deal; Respiratory rivals ResMed, BMC each tally wins in Trade Commission ruling
Medtronic reveals that the tax tab for its top executives from its Covidien buyout will near $58 million, apart from the capital gains taxes all shareholders will pay on the $43 billion deal.
Here's a look at some of the top Wall Street stories for medical device companies this week: Covidien snaps up Reverse Medical; Standard & Poor's maintains credit watch on Medtronic over Covidien buy; Allergan can't delay shareholder vote on hostile Valeant bid; Medtronic drops $200M on Dutch DBS firm Sapiens; Nobel Biocare's Q2 profits double as it fields buyout interest
, Danaher Corp.
, Dentsply International Inc.
, Nobel Biocare Holdings AG
, Pershing Square Capital Management
, Reverse Medical Corp.
, Sapiens Brain Steering Stimulation GmbH
, Standard & Poor's
, Valeant Pharmaceuticals
, Allergan Inc.
Medtronic says it won U.S. clearance for its Shilla growth guidance system, a spinal implant designed to accommodate children's growth as it corrects their early-onset spinal deformities.
Image courtesy Medtronic. Click to enlarge.
Medtech titan Medtronic enrolls the 1st patients in the AdaptResponse clinical trial to evaluate its adaptive cardiac rhythm management technology.
Medtronic (NYSE:MDT) touted the launch of its AdaptResponse trial, the largest study of its kind evaluating the company's AdaptivCRT algorithm for personalizing cardiac resynchronization therapy in treatment of heart failure.