October 2, 2017
According to a new study published in the journal Manufacturing & Service Operations Management, US-based medical device manufacturers could decrease their annual product recalls by as much as 20 percent if they were visited by different FDA representatives for each inspection.
Featured In: Medical Device News
September 29, 2017 - American patients with diabetes may never again have to use a finger stick to monitor their blood glucose levels thanks to Abbott’s new FreeStyle Libre Flash Glucose Monitoring System.
September 19, 2017 - Researchers at Columbia University Medical Center (CUMC) and the University of North Carolina have developed a microneedle skin patch impregnated with a drug capable of converting white fat into calorie-burning brown fat.
September 13, 2017 - The US Food and Drug Administration (FDA) has approved Leica Microsystems’ FL560 fluorescence microscope filter to help surgeons better visualize cerebrovascular blood flow during neurosurgical procedures.
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September 11, 2017 - Researchers at The University of Texas at Austin have developed a disposable cancer identification pen capable of rapidly identifying malignant tissue during surgery.
September 8, 2017 - The medical devices unit of American multinational Johnson & Johnson has announced the formation of a new neurovascular business, Cerenovus.
September 5, 2017 - The US Food and Drug Administration (FDA) has approved NxStage Medical’s System One for solo home hemodialysis, alleviating renal patients’ reliance on nurses and other care providers.
August 29, 2017 - Researchers at the Institute for Biomedical Sciences at Georgia State University have developed a blood test which uses infrared spectroscopy to screen patients for this type of inflammatory bowel disease (IBD).
August 10, 2017 - To support the detection of both innocent and pathological heart murmurs, AUM Cardiovascular has developed a non-invasive medical device which uses both acoustic and electrocardiogram (ECG) technology.
August 4, 2017 - Patients with acute myeloid leukemia (AML), an aggressive form of blood cancer, could now have a new treatment option thanks to the US Food and Drug Administration’s (FDA) approval of Celgene’s Idhifa (enasidenib).
Featured In: Biotech News, Medical Device News
August 1, 2017 - For the first time, the US Food and Drug Administration (FDA) has approved a urine-based immunoassay to detect fentanyl in living patients.
Featured In: Drug Safety News, Medical Device News
July 24, 2017 - Medical device maker Aspect Imaging has received US Food and Drug Administration (FDA) approval for its Embrace Neonatal MRI System.
July 13, 2017 - French medical device manufacturer Defymed is developing an insulin delivery device designed to be implanted into the abdomen of patients with type 1 diabetes.
June 28, 2017 - A team of researchers at the Georgia Institute of Technology and Emory University have shown that a microneedle patch may be a safe and effective way of immunizing people against influenza viruses.
June 20, 2017 - The FDA has approved Adamis Pharmaceuticals’ epinephrine pre-filled syringe, Symjepi.
June 16, 2017 - Rutgers University engineers are developing lab-on-a-chip biosensors that could be integrated into existing wearable devices.
June 14, 2017 - Patients experiencing insomnia may reach for over-the-counter (OTC) or prescription sleep aids to help them fall asleep but physicians at Ebb Therapeutics believe that a drug-free treatment may be a safer way to address sleeping troubles.
June 2, 2017 - Researchers at Duke University have developed a slim, handheld medical device that could revolutionize cervical cancer screening by putting the power in the hands of the women themselves.
Featured In: Medical Device News
May 31, 2017 - In an effort to improve the lifespan of these implantable medical devices and avoid repeat surgery, engineers at Purdue University have developed a self-clearing catheter that uses magnetic force to keep the catheter free of obstructions.
May 29, 2017 - Developing specific medical devices for pediatric patients can be challenging, and larger devices designed for adults are often repurposed for use in this vulnerable population, potentially leading to safety concerns.
May 12, 2017 - The team of researchers from the University of California in San Diego, published their findings in the journal, Annals of Internal Medicine.
May 5, 2017 - Researchers have developed an ingestible electronic capsule which receives power wirelessly through radio waves transmitted by a source outside the body.
April 27, 2017 - Researchers at the Children's Hospital of Philadelphia (CHOP) have developed a womb-like device which mimics the environmental conditions found inside the uterus.
Featured In: Medical Device News, Life Science News
April 19, 2017 - Could a wearable device be just as effective as a sleep clinic at diagnosing sleep apnea following traumatic brain injury?
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.
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.
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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.
Featured In: Medical Device News, Pharmaceutical Marketing News
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.
Featured In: Medical Device News, Medical Device News
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.
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.
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.