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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


Electronic Informed Consent: 2017 Industry Survey Results

Developing a Biological Safety Evaluation

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

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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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