Category: On Call
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.
Apple issues new privacy rules to prevent makers of app-makers from selling health data collected through the tech giant's new HealthKit platform.
MASSDEVICE ON CALL — Tech titan Apple (NSDQ:AAPL) made some recent changes to its app-developer guidelines in order to protect patient data collected through its highly anticipated HealthKit platform, slated to hit the market later this year.
The Boston Business Journal reports that Baxter International is moving its corporate headquarters from Deerfield, Ill. to Cambridge, Mass.
MASSDEVICE ON CALL — Healthcare industry giant Baxter (NYSE:BAX) is moving its corporate headquarters to Massachusetts in a sneaky plot dubbed "Project Tiger" by Bay State economic and business officials, according to a Boston Business Journal report.
Apple's interest in the health space is only growing as the tech giant takes meeting with payors in addition to hospitals and electronic medical record providers.
MASSDEVICE ON CALL — Apple's (NSDQ:AAPL) foray into healthcare appears to be accelerating as the company leads up to the launch of its latest iOS 8 software, which will include the new Health app.
Doctors at a Chinese University implant a 3D-printed vertebra for the 1st time in a 12-year-old patient with a malignant tumor on his spinal cord.
MASSDEVICE ON CALL — In a breakthrough surgery a team of physicians at Peking University implanted a 3D-printed vertebra for the 1st time in a 12-year-old boy with a malignant tumor on his spinal cord.
Speculation arises after FDA reports reveal that leaders from online retailer Amazon took meetings with the federal watchdog agency.
MASSDEVICE ON CALL — Another tech giant may be about to jump into the healthcare space.
Modern Healthcare reported that "leaders" from online retailer Amazon took a meeting last month with the FDA's global regulatory operations & policy deputy commissioner, Howard Sklamberg, as well as other agency officials. The paper noted the meeting in one of the FDA's recent calendar updates.
Opponents of the medical device tax have new grounds for their calls for repeal after a U.S. Treasury report finds that the IRS is having a hard time making sense of the levy.
MASSDEVICE ON CALL — Medical device industry lobbyists have new ammunition in the fight against the 2.3% Affordable Care Act tax thanks to a U.S. Treasury report citing several issues with the IRS's management of the levy.