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Medical News Today: How to tell if a sore throat is from an allergy or a cold

Allergies can cause cold-like symptoms, so it can sometimes be difficult to tell whether a sore throat is due to an alle

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  string(59) "FDA Flags Battery Issue Impacting Some Medtronic Pacemakers"
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  string(59) "FDA Flags Battery Issue Impacting Some Medtronic Pacemakers"
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  string(153) "&#nlFDA alerted patients and physicians on Tuesday to a problem that may cause batteries in certain Medtronic implantable pacemakers or cardi"
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FDA alerted patients and physicians on Tuesday to a problem that may cause batteries in certain Medtronic implantable pacemakers or cardiac resynchronization therapy pacemakers (CRT-Ps) to drain more quickly than expected or without warning.

&#nl

Implanted pacemakers and CRT-Ps have electronics and are powered by lithium-ion batteries. One of the key electronic components is a capacitor, which stores electrical energy.

&#nl

Medtronic said there have been three medical device reports in which one of a Medtronic implantable pacemakers or CRT-P battery had fully drained without warning because of a crack in the device's capacitor. One of the three reported events contributed to a patient's death, the company noted. All three events occurred within one year after the patient was implanted with the device, on average within seven months.

&#nl

FDA said patients who rely heavily on pacing or who are pacemaker dependent may be most at risk for having an adverse outcome if their device battery drains unexpectedly. The devices are designed to last between 7.5 and 15 years or 6 and 10 years before requiring battery replacement, depending on the device and the amount of pacing. 

&#nl

Earlier this year FDA approved a new step in Medtronic's manufacturing process developed to better detect capacitor failures and for a different capacitor to reduce the risk of rapid battery depletion in newly-manufactured devices.

&#nl

Affected Medtronic implantable pacemaker and CRT-P device models include:

&#nl

Azure models: W1DR01, W2DR01, W3DR01, W1SR01, W2SR01, W3SR01

&#nl

Astra models: X1DR01, X2DR01, X3DR01, X1SR01, X2SR01, X3SR01

&#nl

Percepta models: W1TR01, W1TR04, W4TR01, W4TR04

&#nl

Serena models: W1TR02, W1TR05, W4TR02, W4TR05

&#nl

Solara models: W1TR03, W1TR06, W4TR03, W4TR06

&#nl

As of April 10, Medtronic had sold 131,889 of the affected devices in the United States.

&#nl

While the issue presents as rapid battery depletion, this is not a battery performance issue, Medtronic noted. The projected rate for this issue is 0.0028%, with the most susceptible period for a leakage pathway to develop in the capacitor being the first 12 months post-implant, the company said.

&#nl

"Based on the low predicted rate of failure and the recent implementation of process and component enhancements, Medtronic expects few, if any, additional events to occur," the company said. "Medtronic, in consultation with our independent physician quality panel, does not recommend device replacement.  Physicians should continue normal patient follow-up in accordance with standard practice, and where possible, continue to use the low battery voltage wireless CareAlert, together with remote monitoring via the CareLink home monitor or the MyCareLink Heart mobile app."

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FDA alerted patients and physicians on Tuesday to a problem that may cause batteries in certain Medtronic implantable pacemakers or cardiac resynchronization therapy pacemakers (CRT-Ps) to drain more quickly than expected or without warning.

&#nl

Implanted pacemakers and CRT-Ps have electronics and are powered by lithium-ion batteries. One of the key electronic components is a capacitor, which stores electrical energy.

&#nl

Medtronic said there have been three medical device reports in which one of a Medtronic implantable pacemakers or CRT-P battery had fully drained without warning because of a crack in the device's capacitor. One of the three reported events contributed to a patient's death, the company noted. All three events occurred within one year after the patient was implanted with the device, on average within seven months.

&#nl

FDA said patients who rely heavily on pacing or who are pacemaker dependent may be most at risk for having an adverse outcome if their device battery drains unexpectedly. The devices are designed to last between 7.5 and 15 years or 6 and 10 years before requiring battery replacement, depending on the device and the amount of pacing. 

&#nl

Earlier this year FDA approved a new step in Medtronic's manufacturing process developed to better detect capacitor failures and for a different capacitor to reduce the risk of rapid battery depletion in newly-manufactured devices.

&#nl

Affected Medtronic implantable pacemaker and CRT-P device models include:

&#nl

Azure models: W1DR01, W2DR01, W3DR01, W1SR01, W2SR01, W3SR01

&#nl

Astra models: X1DR01, X2DR01, X3DR01, X1SR01, X2SR01, X3SR01

&#nl

Percepta models: W1TR01, W1TR04, W4TR01, W4TR04

&#nl

Serena models: W1TR02, W1TR05, W4TR02, W4TR05

&#nl

Solara models: W1TR03, W1TR06, W4TR03, W4TR06

&#nl

As of April 10, Medtronic had sold 131,889 of the affected devices in the United States.

&#nl

While the issue presents as rapid battery depletion, this is not a battery performance issue, Medtronic noted. The projected rate for this issue is 0.0028%, with the most susceptible period for a leakage pathway to develop in the capacitor being the first 12 months post-implant, the company said.

&#nl

"Based on the low predicted rate of failure and the recent implementation of process and component enhancements, Medtronic expects few, if any, additional events to occur," the company said. "Medtronic, in consultation with our independent physician quality panel, does not recommend device replacement.  Physicians should continue normal patient follow-up in accordance with standard practice, and where possible, continue to use the low battery voltage wireless CareAlert, together with remote monitoring via the CareLink home monitor or the MyCareLink Heart mobile app."

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FDA Flags Battery Issue Impacting Some Medtronic Pacemakers

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  string(42) "Improving Preterm Infant Health Through AI"
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  string(42) "Improving Preterm Infant Health Through AI"
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Astarte Medical is working to protect the lives of newborns much like the goddess its name is derived from. The Yardley, PA-based company is focused specifically on premature babies and hopes to improve their health outcomes through the use of artificial intelligence and electronic health records.

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On Tuesday, executives from Astarte Medical spoke with MD+DI about the company’s mission and the $5 million raised during a series A financing.

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The company was founded in April of 2016 by venture capitalists and serial entrepreneurs Tracy Warren and Tammi Jantzen, Together, they are applying their expertise and business acumen to the vision of Katherine Gregory, PhD, RN, the company's scientific co-founder.

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Tammi and I have worked together the last 18 years,” Warren, who also serves as CEO for Astarte, told MD+DI. “We really started our career together in early stage VC in the greater Philadelphia region. About six years we decided that we wanted to continue working together and really focus our energies on an area that was of personally of interest to us, which is women and infant health.”

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Every year, more than 380,000 babies are born prematurely in the U.S. The first 1,000 days of life are a critical period for a baby's growth and brain development – particularly for preterm infants – and maintaining a healthy gut is crucial during this time. The rapid changes in the microbiome during this period make it challenging for NICU teams to treat infants with a highly personalized level of care.

&#nl

“We’re surviving kids as early as 22 weeks gestation in the nation’s top centers,” Warren said. “The challenge we have is while we’ve gotten very good at fixing things like the heart and the lung, we’re really struggling to help these kids grow and develop through nutrition and feeding. What we’ve done at Astarte Medical and what [our] platform seeks to do is to improve the gut … and to use technology and software that’s available in the clinic to help inform and empower clinicians who are caring for these very tiny babies.”

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Warren said by improving growth and brain development, that the company believes in these early formative stages, primarily in the first 1,000 days of life, that there can be an improvement in health outcomes; reduction in the length of stay for these kids; and overall improvement in a preterm child’s trajectory for lifelong health.

&#nl

The financing will be used to help develop the firm’s NICUtrition suite of products. Investors in the round include Viking Global Investors LP, Lunsford Capital, OCA Ventures, Keiretsu Forum MidAtlantic, Keiretsu Capital Fund, Ben Franklin Technology Partners, Wing VC and Next Act Fund.

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Astarte Medical is working to protect the lives of newborns much like the goddess its name is derived from. The Yardley, PA-based company is focused specifically on premature babies and hopes to improve their health outcomes through the use of artificial intelligence and electronic health records.

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On Tuesday, executives from Astarte Medical spoke with MD+DI about the company’s mission and the $5 million raised during a series A financing.

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The company was founded in April of 2016 by venture capitalists and serial entrepreneurs Tracy Warren and Tammi Jantzen, Together, they are applying their expertise and business acumen to the vision of Katherine Gregory, PhD, RN, the company's scientific co-founder.

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Tammi and I have worked together the last 18 years,” Warren, who also serves as CEO for Astarte, told MD+DI. “We really started our career together in early stage VC in the greater Philadelphia region. About six years we decided that we wanted to continue working together and really focus our energies on an area that was of personally of interest to us, which is women and infant health.”

&#nl

Every year, more than 380,000 babies are born prematurely in the U.S. The first 1,000 days of life are a critical period for a baby's growth and brain development – particularly for preterm infants – and maintaining a healthy gut is crucial during this time. The rapid changes in the microbiome during this period make it challenging for NICU teams to treat infants with a highly personalized level of care.

&#nl

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&#nl

Warren said by improving growth and brain development, that the company believes in these early formative stages, primarily in the first 1,000 days of life, that there can be an improvement in health outcomes; reduction in the length of stay for these kids; and overall improvement in a preterm child’s trajectory for lifelong health.

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Improving Preterm Infant Health Through AI

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Medical News Today: What are the best fermented foods?

Fermented foods, including kombucha, miso, tempeh, and sauerkraut, offer a variety of health benefits. Learn about these

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Burden of Heart Failure-Related CVD Mortality Higher in Blacks

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Medical News Today: Is it safe to drink alcohol while taking prednisone?

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Medical News Today: Natural ways to lower cholesterol

High cholesterol levels can increase a person’s risk of heart disease. Natural ways to lower cholesterol include