April 19, 2017
Could a wearable device be just as effective as a sleep clinic at diagnosing sleep apnea following traumatic brain injury?
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April 17, 2017 - A small microfluidic device, designed by researchers at Brigham Young University, could help physicians predict whether a pregnant woman is at risk of delivering her baby early.
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April 6, 2017 - Digital health startup, VivaLnk, has just received FDA clearance for their continuous temperature monitoring medical device, Fever Scout.
April 4, 2017 - Meridian Medical, a Pfizer-owned company and Mylan’s manufacturing partner for the EpiPen, has expanded its recall of the medical device to include lots distributed in the US.
March 30, 2017 - Researchers at Brigham and Women’s Hospital and Massachusetts General Hospital have developed a system that analyses the quantity and quality of sperm through an easy-to-use smartphone app.
Electronic Informed Consent: 2017 Industry Survey Results
Developing a Biological Safety Evaluation
March 28, 2017 - Researchers at Trinity College Dublin in Ireland have identified a small molecule capable of preventing bacterial biofilms from growing on medical implants.
March 15, 2017 - A needle-free device developed by researchers at UC Berkeley, could be the next big thing in vaccine delivery technology.
March 2, 2017 - Despite the debate surrounding the procedure, medical device company CeloNova Biosciences believe their nanocoated stent may be a good alternative to traditional drug-eluting stents for some patients.
February 21, 2017 - Researchers at the University of British Columbia (UBC) have developed Canada’s first magnetic drug implant as an alternative mode of drug delivery.
February 17, 2017 - According to a new study published in the journal, Circulation: Cardiovascular Quality and Outcomes, patients who receive a shock from an implantable cardioverter defibrillator (ICD) could require further medical attention for cardiac issues.
February 8, 2017 - Pediatric testing company, Baebies, has announced that their newborn screening platform has received marketing clearance from the US Food and Drug Administration (FDA).
February 7, 2017 - Researchers at The Wyss Center at Campus Biotech in Geneva, Switzerland, have found that a non-invasive brain-computer interface could facilitate communication for patients with ALS.
February 2, 2017 - Colonoscopes and other gastrointestinal devices are rigorously cleaned between procedures, however a new study has found that these practices may not be enough to remove contaminants such as bacteria and other biological material.
January 25, 2017 - Much to the dismay of insurers and pharmacy benefit managers, Kaléo Pharma has announced that the list price for a two-pack of its EpiPen alternative auto-injectors will be set at $4,500.
January 25, 2017 - In 2016, adoption of the EarlySense continuous medical monitoring system increased by almost 40 percent, to include over 105 clinical care areas around the world.
January 23, 2017 - A soft robotic sleeve which supports contraction of the heart muscle has been developed by researchers at Harvard University and Boston Children’s Hospital.
January 11, 2017 - Drug discovery and development company, Evotec, has signed an agreement with Efferent Labs to develop its proprietary implantable biosensor technology.
December 15, 2016 - Medical device manufacturer, H&T Presspart, and medtech firm, Cohero Health have launched the first connected metered dose inhaler (eMDI) to track – and potentially improve – medication adherence in patients with asthma and chronic obstructive pulmonary disease (COPD).
December 7, 2016 - A medical device which provides transcranial electromagnetic treatment (TEMT) to the brain, is being investigated in a new clinical trial involving patients with Alzheimer’s disease.
December 6, 2016 - While the amount of acetone present in a patient’s breath is an accurate biomarker for blood glucose concentration, breathalyzer technology was previously not developed enough for clinical use.
November 30, 2016 - Researchers at North Carolina State University (NC State) and the University of North Carolina (UNC) at Chapel Hill, have developed a smart sensing patch which can automatically release blood thinners – such as heparin – in response to rising blood clotting factor levels.
November 28, 2016 - The disposable point-of-care device – which can be plugged into a computer to view test results – could help HIV patients monitor the effectiveness of their treatment.
November 25, 2016 - As a medical monitoring device, the skin patch could help physicians diagnose an irregular heartbeat.
November 24, 2016 - The test could see the most clinical utility in assessing patients with Barrett’s esophagus, a condition resulting in cell damage due to recurrent acid reflux.
November 1, 2016 - The US Food and Drug Administration (FDA) has approved a medical device – called the Amplatzer PFO Occluder – for the prevention of recurrent strokes in select patients.
October 31, 2016 - The Aerobika medical device – marketed by Trudell Medical International (TMI) – was able to reduce antibiotic and oral corticosteroid use by 57 and 89 percent, respectively, when combined with the standard COPD treatment.
October 27, 2016 - While Mylan’s controversial EpiPen currently holds significant market share, the medical device is about to face some stiff competition.
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October 26, 2016 - According to the results of a 128,000-patient study conducted by ResMed, sleep apnea patients who use a self-management app in conjunction with positive airway pressure (PAP) are more likely to adhere to their therapy.
October 19, 2016 - According to a study conducted by researchers in Denmark, while the use of surgical mesh as a medical device for hernia repair has been associated with a lower risk of recurrence, these benefits also come with a risk of long-term mesh-related complications.
October 5, 2016 - In a surprising turn, Theranos founder Elizabeth Holmes has announced the company will be shutting down clinical testing labs and consumer blood testing services, in order to focus on its recently-unveiled miniLab medical device.
October 5, 2016 - The Switch medical device has a range of applications, from stitching-up blood vessels to closing incisions made in the skin, and could save surgeons considerable time in the operating room.
September 30, 2016 - This week the US Food and Drug Administration (FDA) approved the first artificial pancreas device, designed to automatically monitor glucose levels and administer insulin to patients with type 1 diabetes.
September 14, 2016 - Health organizations worldwide have instituted screening programs in an effort to decrease DR related morbidity and healthcare costs.
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September 6, 2016 - Researchers at the University of Pittsburgh have used ultrasound and microbubbles to effectively deliver gene therapy into cells.
Featured In: Medical Device News, Biotech News
August 22, 2016 - The Babyscripts app prompts patients to measure their blood pressure and weight at least once per week – data which is transmitted to the physician using Wi-Fi for remote monitoring.
August 11, 2016 - Germany’s Emperra GmbH is preparing to launch the world’s first insulin pen, capable of wirelessly transmitting information on insulininjections to an external blood glucose management device.
August 9, 2016 - A new blood test developed by researchers at Randox Laboratories could help identify patients who face a higher risk of developing Alzheimer’s disease.
August 3, 2016 - At the American Association for Clinical Chemistry (AACC) conference this week, Theranos CEO and founder Elizabeth Holmes unveiled the details of a new blood testing device, called the miniLab.
July 12, 2016 - The US Food and Drug Administration (FDA) has approved a new monthly, single dose medical device - called Pushtronex - for the infusion of the LDL cholesterol-lowering drug, Repatha.
July 11, 2016 - The Centers for Medicare & Medicaid Services (CMS) has officially banned Theranos founder Elizabeth Holmes from owning or operating a blood testing laboratory, for a minimum two-year period.
June 14, 2016 - The US pharmacy giant is set to close all 40 of the Theranos blood testing centers in its Arizona drugstores.
June 2, 2016 - Roche has launched a new PT/INR home self-testing device for European patients taking anticoagulant drugs.
May 27, 2016 - Earlier this week, a class action lawsuit was filed in a federal court against controversial laboratory services company, Theranos.
May 10, 2016 - The portable device was able to identify the virus in the blood and saliva of infected monkeys.
May 6, 2016 - To help patients better adhere to their glaucoma treatments, researchers from the UC Davis Medical Center Glaucoma Service have developed a drug-dispensing eye insert that slowly releases medication.
April 27, 2016 - Researchers at the University of Bath have developed a new catheter coating that changes the colour of the urine in response to growing bacterial numbers.
Featured In: Medical Device News, Life Science News
April 26, 2016 - As artificial pancreas devices in development continue to move closer to hitting the market, talk of how the devices will be regulated is starting to gain momentum.
April 26, 2016 - In an effort to modernize the technology, Fujifilm has just received US Food and Drug Administration (FDA) clearance for its high-frequency, high resolution ultrasound machine, Vevo MD.
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April 19, 2016 - In order to improve the outcomes for patients who rely on these implantable devices, researchers from Harvard have developed a biochemical method capable of regenerating a protective bioactive film which prevents the body from attacking the implant.
April 15, 2016 - Health technology company Seventh Sense Biosystems, have announced they have begun registration for a pivotal clinical trial for their painless drug collection device.
April 6, 2016 - The Pyxis SupplyStation – designed to dispense medical supplies based on fingerprint identification of authorized personnal – was evaluated by independent researchers who found that the system could be accessed remotely.
April 4, 2016 - Ireland-based Medtronic has gained additional US Food and Drug Administration (FDA) approval for their PillCam COLON 2 ingestible capsule.
March 31, 2016 - Medical device manufacturers are increasingly developing technologies designed to monitor patients’ adherence to medication schedules.
March 23, 2016 - Inovio will pay $5.5 million in cash and company stock for the technology, which it plans to combine with its own skin- surface electroporation DNA vaccine administration technique.
March 16, 2016 - Researchers at the University of North Carolina at Chapel Hill (UNC) and North Carolina State University (NC), have designed a synthetic patch impregnated with live beta cells, capable of secreting insulin in response to rising blood glucose levels.
March 11, 2016 - A review conducted by Florida International University, suggests that a portable, sensitive biosensor may heathcare providers monitor the progression of Alzheimer’s disease – even in underdeveloped countries.
February 22, 2016 - Novartis’ eye care unit, Alcon, has bought Transcend Medical to acquire the company’s minimally invasive glaucoma surgery (MIGS) devices.
February 19, 2016 - A team of researchers at Vanderbilt University Medical Center in Nashville, Tennessee, are developing a microchip-based artificial kidney which could give new hope to dialysis patients waiting for a donor organ.
January 20, 2016 - A group of neurosurgeons and engineers from the Washington University School of Medicine, in collaboration with researchers from the University of Illinois at Urbana- Champaign, have developed a bioresorbable brain sensor that eliminates the need for additional surgery to remove the device.
January 20, 2016 - Earlier this week, the US Food and Drug Administration (FDA) released a draft guidance document detailing measures to be taken by medical device manufacturers, in order to ensure the postmarket cybersecurity of their devices.
January 6, 2016 - Just before the end of 2015, France-based antibiotic test developer, bioMérieux, received notice that their diagnostic tests would be subject to a US Food and Drug Administration (FDA) Class I recall due to the risks that the tests could produce false positives.