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Medical Device Manufacturers More Likely to Issue Recall After Subsequent Visits from Same FDA Inspector

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

Abbott’s Continuous Glucose Monitoring System to Replace Finger Sticks for Diabetics

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.

Featured In: Medical Device News

Microneedle Skin Patch Could Treat Common Metabolic Disorders

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.

Featured In: Medical Device News

Leica’s Fluorescence Microscope Filter Helps Surgeons See Blood Flow in the Brain

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.

Featured In: Medical Device News


Why Track and Trace Isn’t Just Tracking and Tracing: Best Practices for Implementing a Solution That Works

What Does it Take to Successfully Execute Large, Global, Phase III Programs?

Cancer-Detecting Pen to Help Guide Surgeons in Tumor Resection

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.

Featured In: Medical Device News

Johnson & Johnson Launches Neurovascular Business with Focus on Developing Stroke Therapies

September 8, 2017 - The medical devices unit of American multinational Johnson & Johnson has announced the formation of a new neurovascular business, Cerenovus.

Featured In: Medical Device News

Hemodialysis Device Approved for Home Use Could Improve Quality of Life for Kidney Failure Patients

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.

Featured In: Medical Device News

Could a Blood Test Reduce the Need for Colonoscopies in the Diagnosis of Ulcerative Colitis?

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).

Featured In: Medical Device News

Handheld Medical Device to Help in Detection of Heart Murmurs

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.

Featured In: Medical Device News

FDA Approves Celgene’s AML Treatment Paired with Abbott’s Companion Diagnostic

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

FDA-Approved Fentanyl Drug Screening Assay to Help Identify Opioid Abuse

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

Neonatal MRI Medical Device Approved by the FDA

July 24, 2017 - Medical device maker Aspect Imaging has received US Food and Drug Administration (FDA) approval for its Embrace Neonatal MRI System.

Featured In: Medical Device News

Defymed to Develop an Implantable Device for Insulin Delivery and Improved Diabetes Management

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.

Featured In: Medical Device News

Microneedle Patch Could Revolutionize Flu Vaccination

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.

Featured In: Medical Device News

Adamis Pharmaceuticals’ EpiPen Rival Gains FDA Approval

June 20, 2017 - The FDA has approved Adamis Pharmaceuticals’ epinephrine pre-filled syringe, Symjepi.

Featured In: Medical Device News

Wearable Biosensors Could Detect Biomarkers, Pathogens and Pollutants

June 16, 2017 - Rutgers University engineers are developing lab-on-a-chip biosensors that could be integrated into existing wearable devices.

Featured In: Medical Device News

Ebb Therapeutics Medical Device Cools Frontal Cortex to Offer Relief from Insomnia

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.

Featured In: Medical Device News

Handheld Medical Device to Improve Access to Cervical Cancer Screening

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

Self-Clearing Catheter Technology Could Improve Lifespan of Implantable Medical Devices

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.

Featured In: Medical Device News

Cardiac Safety Study Could Encourage Development of Pediatric Medical Devices

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.

Featured In: Medical Device News

EpiPen May Retain Potency up to Four Years After Expiration Date

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.

Featured In: Medical Device News

Wireless Source Could Power Medical Devices from Outside the Body

May 5, 2017 - Researchers have developed an ingestible electronic capsule which receives power wirelessly through radio waves transmitted by a source outside the body.

Featured In: Medical Device News

Womb-Like Device Could Increase Survival of Premature Babies

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

Wearable Device Could Help Diagnose Sleep Apnea after Traumatic Brain Injury

April 19, 2017 - Could a wearable device be just as effective as a sleep clinic at diagnosing sleep apnea following traumatic brain injury?

Featured In: Medical Device News

Lab-on-a-Chip Detects Biomarkers for Preterm Birth

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.

Featured In: Medical Device News

FDA Approves VivaLnk’s Wearable Device for Continuous Temperature Monitoring

April 6, 2017 - Digital health startup, VivaLnk, has just received FDA clearance for their continuous temperature monitoring medical device, Fever Scout.

Featured In: Medical Device News

Mylan’s Voluntary EpiPen Recall Now Includes US

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.

Featured In: Medical Device News

Home-Based Smartphone Male Fertility Test Could Improve Access to Sperm Testing

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.

Featured In: Medical Device News

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Small Molecule May Disrupt Biofilm Formation on Implantable Medical Devices

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.

Featured In: Medical Device News

Needle-Free Self-Administered Vaccines Could Be in Our Future

March 15, 2017 - A needle-free device developed by researchers at UC Berkeley, could be the next big thing in vaccine delivery technology.

Featured In: Medical Device News

FDA Approves Nanocoated Cardiac Stent as Alternative Device for Heart Disease Patients

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.

Featured In: Medical Device News

Magnetic Implant Could Offer Improved Control Over Drug Delivery

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.

Featured In: Medical Device News

Implantable Defibrillator Could Present More Cardiac Problems for Some Patients

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.

Featured In: Medical Device News

Newborn Screening System for Rare Diseases Gets FDA Green Light

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).

Featured In: Medical Device News

Brain-Computer Interface Allows Late-Stage ALS Patients to Communicate

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.

Featured In: Medical Device News

Despite Cleaning, Bacterial Biofilms Remain Within Colonoscopes

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.

Featured In: Medical Device News

Kaléo Pharma’s EpiPen Alternative Launched with Expensive List Price

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.

Featured In: Medical Device News

EarlySense Patient Monitoring System Saw 40 Percent Increase in Adoption in 2016

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.

Featured In: Medical Device News

Soft Robotic Medical Device to Benefit Patients with Heart Failure

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.

Featured In: Medical Device News

Efferent Labs’ Implantable Biosensor Technology to be Further Developed by Evotec

January 11, 2017 - Drug discovery and development company, Evotec, has signed an agreement with Efferent Labs to develop its proprietary implantable biosensor technology.

Featured In: Medical Device News

Metered Dose Inhaler with Wireless Connectivity to Track Medication Adherence

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).

Featured In: Medical Device News

Could Electromagnetic Treatment Reverse Memory Loss in Alzheimer’s Disease Patients?

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.

Featured In: Medical Device News

Blood Glucose Testing For Diabetes Management Could Be Replaced By Breathalyzer

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.

Featured In: Medical Device News

Smart Patch Delivers Anticoagulants in Response to Blood Thrombin Levels

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.

Featured In: Medical Device News

Point-of-Care HIV Diagnostic on a USB Stick

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.

Featured In: Medical Device News

Electronic Tattoo to Monitor Vital Signs Through Skin

November 25, 2016 - As a medical monitoring device, the skin patch could help physicians diagnose an irregular heartbeat.

Featured In: Medical Device News

Cell-Collecting Sponge Could Replace Endoscopies for Esophageal Cancer

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.

Featured In: Medical Device News

Medical Device for Stroke Prevention Approved By FDA

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.

Featured In: Medical Device News

Medical Device Reduces Need for Medication to Treat COPD

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.

Featured In: Medical Device News

EpiPen Alternative Could Hit Pharmacy Shelves Next Year

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

World’s Largest Study on Sleep Apnea Suggests Apps Improve Patient Adherence

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.

Featured In: Medical Device News

Studying the Risks and Benefits of Using Surgical Mesh for Hernia Repair

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.

Featured In: Medical Device News

Theranos Closes Labs, Focuses On New Medical Device

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.

Featured In: Medical Device News

Single-Handed Suturing Medical Device Developed By Mellon Medical

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.

Featured In: Medical Device News

FDA Approves First Artificial Pancreas Medical Device For Type 1 Diabetes

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.

Featured In: Medical Device News

New Technology Allows Earlier Detection of Eye Disease

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

Ultrasound Delivery Could Improve Efficacy Of Gene Therapy

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

Babyscripts Mobile App To Help Clinicians Deliver Improved Prenatal Care

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.

Featured In: Medical Device News

Emperra Launches First Bluetooth-Enabled Insulin Pen For Diabetes Management

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.

Featured In: Medical Device News

Biochip Blood Test Could Identify Those With An Increased Risk Of Alzheimer’s Disease

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.

Featured In: Medical Device News

Theranos Founder Announces New Blood Testing Device

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.

Featured In: Medical Device News

FDA Approves Medical Device For Monthly Injection Of PCSK9 Inhibitor

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.

Featured In: Medical Device News

Theranos Founder Receives 2-Year Ban From Owning Blood-Testing Lab

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.

Featured In: Medical Device News

Walgreens Terminates Partnership With Blood Test Company, Theranos

June 14, 2016 - The US pharmacy giant is set to close all 40 of the Theranos blood testing centers in its Arizona drugstores.

Featured In: Medical Device News

Roche’s Home Healthcare Medical Device For Anticoagulant Therapy Launches In Europe

June 2, 2016 - Roche has launched a new PT/INR home self-testing device for European patients taking anticoagulant drugs.

Featured In: Medical Device News, Pharmaceutical Marketing News

Theranos Faces Class Action Lawsuit Over Inaccurate Blood Test

May 27, 2016 - Earlier this week, a class action lawsuit was filed in a federal court against controversial laboratory services company, Theranos.

Featured In: Medical Device News

Zika Diagnostic Could Rapidly Detect The Virus

May 10, 2016 - The portable device was able to identify the virus in the blood and saliva of infected monkeys.

Featured In: Medical Device News

Slow-Release Drug Delivery Device Could Offer New Treatment Option For Glaucoma Patients

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.

Featured In: Medical Device News

Catheter Infection Alert System Could Prevent Life-Threatening Infections

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

Upcoming NIH Meeting To Discuss Artificial Pancreas As Diabetes Device

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.

Featured In: Medical Device News, Life Science News

FDA Approves First High-Frequency Ultrasound Machine

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.

Featured In: Medical Device News

Improving Bioactive Films For Long-Term Implantable Medical Device Stability

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.

Medical Device Maker Seeks FDA and EU Approval Of Pain-Free Blood Collection Device

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.

US Homeland Security Issues Warning About Cybersecurity Vulnerabilities With Supply Management System

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.

Medtronic’s PillCam Receives FDA Clearance For High-Risk Patients

April 4, 2016 - Ireland-based Medtronic has gained additional US Food and Drug Administration (FDA) approval for their PillCam COLON 2 ingestible capsule.

Medication Adherence Monitors Are Next Trend In Medical Devices

March 31, 2016 - Medical device manufacturers are increasingly developing technologies designed to monitor patients’ adherence to medication schedules.

Inovio Pays $5.5 Million For Bioject’s Needle-Free Injection Device Technology

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.

Beta Cell Patch Could Control Insulin Levels In Patients With Diabetes

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.

Portable Biosensor Could Improve Alzheimer’s Disease Management

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.

Novartis Acquires Glaucoma Surgical Device Maker To Bolster Alcon Eye Care Division

February 22, 2016 - Novartis’ eye care unit, Alcon, has bought Transcend Medical to acquire the company’s minimally invasive glaucoma surgery (MIGS) devices.

Implantable Artificial Kidney Could Be Functional Organ Replacement

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.

Dissolvable Brain Sensor Developed To Monitor Patients With Traumatic Brain Injury

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.

FDA Highlights Cybersecurity Measures For Medical Device Manufacturers

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.

Diagnostic Test Developer bioMérieux Receives FDA Class I Recall

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.

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