Researchers at the University of California San Francisco have developed an implantable bioreactor that may...

Researchers at the University of Texas at Austin have developed an electroencephalogram (EEG) sensor that...

FDA Issues Final Guidance on Cybersecurity in Medical Devices     The FDA has issued the...

Precision Medicine Meets AI: Advances in Cough Monitoring     Cough is a common and, at...

The Power of AI to Enhance Clinical Trials     Clinical trials are essential to the...

Researchers at RMIT in Australia have developed a drug-free approach to kill bacteria and fungi...

Researchers at the Terasaki Institute in Los Angeles have developed a new method to create...

Instructional Materials: The Basis for Safety Between Users and Medical Devices     In the rapidly...

FDA Updates Breakthrough Devices Program Guidance     The FDA has issued an update to the...

Researchers at Nanyang Technological University in Singapore have developed a tiny, flexible battery that is...

Researchers at the University of Colorado Anschutz Medical Campus have developed a technique that may...

Researchers at ETH Zurich have developed an insulin delivery system that relies on music as...

Researchers at the University of California San Francisco have developed a brain computer interface that...

<!– Medical Innovation Exchange September 14, 2023 12:50 pm https://www.medgadget.com/2023/09/highly-precise-pressure-sensor-for-laparoscopic-or-robotic-surgical-tools.html

Researchers at the Harvard Wyss Institute have developed a technique that lets clinicians to characterize...

FDA Updates Guidance on ISO 10993-1 for Evaluation of Biocompatibility       The FDA has...

Successful Development, Approval and Deployment of Digital Health Solutions     For life sciences companies seeking...

Revolutionizing Healthcare: Augmented Reality’s Unprecedented Impact     The landscape of healthcare has undergone an evolution...

Researchers at the University of Washington School of Medicine have developed a method to create...

Researchers at Stanford University have developed a new type of cancer therapy. The technology targets...

Researchers at the University of Edinburgh have developed a new method to create multilayered tubes...

Researchers at the University of California San Diego have created a bacterial sentinel system that...

Researchers at Washington University School of Medicine have developed a COVID-19 breathalyzer test. The technology...

FDA Issues Three New Draft Guidances on the 510(k) Program     On September 6, the...

Reshaping of the Biotech M&A Landscape     The biotechnology industry has always been marked by...

HiRO Enters U.S. with Acquisition of CRO Courante Oncology     Harvest Integrated Research Organization (HiRO),...

EU MDR Annex XVI Introduces New Burdens for Products Without an Intended Medical Purpose    ...

Researchers at New York University have developed a new method to target many viruses that...

Get Well Achieves FedRAMP Authorized Designation     Get Well, a provider of enterprise digital patient...

UK Releases Draft Post Market Surveillance Requirements for Medical Devices     The UK has released...

Advanced Solutions to Prevent Undesired Moisture in Pharmaceutical Manufacturing     Excess humidity can affect a...

Having passed the mid-year point, it is always an interesting exercise to take stock of...

<!– Medical Innovation Exchange August 25, 2023 12:57 pm https://www.medgadget.com/2023/08/uv-free-air-decontamination-interview-with-sorel-rothschild-vp-at-quantum-innovations.html

Researchers at the Mount Sinai Hospital have developed an mRNA-based treatment for cancer. The approach...

Scientists at New York University have developed a gene therapy for chronic pain. The technology...

Medtronic Announces First Patient Treated in Global Collaboration with Cydar Medical     Medtronic announced that...

MD PnP Presents Remote Control Care Testing and Verification Method     At the 2023 Military Health...

Researchers at MIT have developed a wearable ultrasound system that is intended to allow women...

Researchers at Oregon State University have developed a drug delivery system that is intended to...

Researchers at the Harvard John A. Paulson School of Engineering and Applied Sciences have developed...

MRI Safety Testing:  Making Implants More Compatible with Magnetic Resonance Imaging     Magnetic resonance imaging...

FDA Seeks Input on At-Home Use Medical Technologies     The FDA Center for Devices and...

For the second time this month and the third time this year, FDA’s OPDP has...

Researchers at the University of Leeds in the UK have developed a magnetic tentacle robot...

Mitigating Supply Chain Risks     On November 8-9, members of the Medtech community will gather...

Final Guidance for Submission of Off-The-Shelf Software in Medical Devices     On August 11, the...

In what has been a long period of relative low activity, FDA’s OPDP has taken...

MedTech Marketing Pearls for FDA Clearance and Beyond      Product marketing touches every function of...

Bringing More Patients Home     Overcrowded emergency departments, a lack of hospital beds and skyrocketing...

Every six months, we do a look-back to see what has changed in the way...

Researchers at the University of Würzburg in Germany have developed a portable scanner that is...

Researchers at the University of Ottawa have developed a light-activated hydrogel treatment for corneal disease....

<!– Medical Innovation Exchange August 8, 2023 1:36 pm https://www.medgadget.com/2023/08/earlipoint-evaluation-system-for-asd-diagnosis-interview-with-tom-ressemann-ceo-of-earlitec-dx.html

Researchers at ETH Zurich have developed a bacteriophage system to identify and treat bacterial bladder...

Engineers at the Technical University of Munich in Germany have developed a system that allows...

Researchers at the Harvard Wyss Institute have developed an anti-cancer biomaterial treatment that combines adoptive...

Researchers at the Institute of Science and Technology Austria have developed a brain imaging technique...

<!– Medical Innovation Exchange August 4, 2023 12:18 pm https://www.medgadget.com/2023/08/visually-guided-uterine-biopsies-in-physicians-office-interview-with-allison-london-brown-ceo-of-luminelle.html

Researchers at Chalmers University of Technology in Sweden have developed a new technique that could...

Researchers at Duke University have developed a gravity-powered microfluidic device that is intended for use...

FDA CDRH To Host Virtual Workshop to Enhance Clinical Study Diversity     The FDA, in...

FDA CDRH To Host Virtual Workshop to Enhance Clinical Study Diversity     The FDA, in...

The Underrated Variable of IoMT Device Security: Collaboration     Healthcare delivery organizations face significant operational...

The Underrated Variable of IoMT Device Security: Collaboration     Healthcare delivery organizations face significant operational...

Scientists at Queen Mary University of London have developed an artificial muscle that can change...

Researchers at Northwestern University have developed a cardiac monitoring device that is intended for use...

Researchers at the Terasaki Institute for Biomedical Innovation in California have developed an implantable sponge...

Join J&J, Pfizer and FDA at the Supply Chain Summit and Advanced Manufacturing Conference    ...

Join J&J, Pfizer and FDA at the Supply Chain Summit and Advanced Manufacturing Conference    ...

It’s Time for MedTech to Recognize PFAS Urgency     Over the past 85 years, perfluoroalkyl...

It’s Time for MedTech to Recognize PFAS Urgency     Over the past 85 years, perfluoroalkyl...

Sonio Receives FDA 510(k) Clearance For Use of AI in Prenatal Ultrasounds     Sonio has...

Sonio Receives FDA 510(k) Clearance For Use of AI in Prenatal Ultrasounds     Sonio has...

Researchers at the University of Hong Kong have developed a microneedle patch for the drug-free...

FDA Announces Expansion of Total Product Life Cycle Advisory Program Pilot     Beginning October 1,...

FDA Announces Expansion of Total Product Life Cycle Advisory Program Pilot     Beginning October 1,...

The Promise and Potential Pitfalls of AI in Medical Device Design     Continuous improvements in...

The Promise and Potential Pitfalls of AI in Medical Device Design     Continuous improvements in...

FDA CDRH Takes Additional Steps To Advance Innovation in Medical Device Sterilization     In response...

FDA CDRH Takes Additional Steps To Advance Innovation in Medical Device Sterilization     In response...

The Expansion of IoMT Technology Requires Stringent Privacy Protections     In the life sciences industry,...

The Expansion of IoMT Technology Requires Stringent Privacy Protections     In the life sciences industry,...

Engineers at the Federal University of Espirito Santo in Brazil have developed smart pants that...

Scientists at the City University of Hong Kong have developed a coating for wearable technologies...

The (Re-) Emergence of the Age of Enablement:  Amgen v. Sanofi     On May 18,...

The (Re-) Emergence of the Age of Enablement:  Amgen v. Sanofi     On May 18,...

Engineers at the University of Sydney have developed a photonic radar that allows them to...

Researchers at the National University of Singapore have created a wound sensor patch that measures...

Nevro, a medtech company based in California, has developed the HFX iQ spinal cord stimulation...

Researchers at Florida Atlantic University have developed a soft robotic glove that can assist stroke...

Scientists at Penn State have developed an assay that lets them to directly measure HIV...

Researchers at UCLA have developed a wearable patch that can measure muscle movements in underlying...

Researchers at the University of British Columbia have developed a protein-based hydrogel that is highly...

Researchers at the University of Washington have developed an app that converts common smartphones into...

Researchers at the University of Birmingham in the UK have developed a wearable that can...

FDA Announces Center of Excellence in Regulatory Science Award Recipients     The FDA, Office of...

Leveraging RFID and IoT to Increase Supply Chain Efficiency     Supply chain disruptions present significant...

Partnering to Support Sustainability in the OR     A recent study from Ethicon and the...

<!– Medical Innovation Exchange July 12, 2023 10:53 am https://www.medgadget.com/2023/07/misha-knee-system-absorbs-shocks-interview-with-anton-clifford-ceo-of-moximed.html

AdvaMed Warns EPA of Massive Interruption to Patient Care     In comments filed with the...

Perseverance Is Key     In the course of her career, Maria Shepherd, president and founder...

Bringing your Medical Device to the UK: What You Need to Know about UKRP    ...

Engineers at MIT have developed a microelectronic probe that can measure and influence the behavior...

Researchers at the University of London have collaborated with QuantuMDx, a medtech company based in...

Researchers at Harvard University have developed a technique that lets them create biomaterial heart valves...

Scientists at the Swiss Federal Laboratories for Materials Science and Technology (EMPA) have developed an...

FDA Approves Abbott’s Dual Chamber Leadless Pacemaker     The FDA has approved Abbott’s AVEIR dual...

Device Development: A Hybrid Implantable Kidney     Shuvo Roy, Ph.D., Professor of Bioengineering at UCSF...

Managing the Post-Pandemic Pricing Squeeze     During the pandemic, OEMs and large suppliers of technology...

Researchers at MIT have developed a metal-free electrode using conductive polymers. The electrode is flexible...

Researchers at the University of Connecticut have developed an ultrasound implant that can assist in...

Leveraging AI & ML in MedTech: Power Consumption and Latency     In my last Artificial...

Device Development: Noninvasive Brain Stimulation     Last month Pulvinar Neuro, a subsidiary of Electromedical Products...

The MDR Deadline Extension: Use the Time Wisely     On March 15, 2023, the European...

Boston Scientific Elects Dr. Jessica L. Mega and Susan E. Morano to Board of Directors  ...

<!– Medical Innovation Exchange June 26, 2023 8:37 am https://www.medgadget.com/2023/06/shelf-stable-breast-milk-powder-interview-with-dr-vansh-langer-ceo-at-bby.html

Researchers at the Singapore University of Technology and Design have created a flexible knee wearable...

Scientists at Rice University have developed a highly flexible nanoelectrode that is designed for long-term...

Managing Software Vulnerabilities: How to Utilize ISA/IEC 62443 and Software Bills of Materials     In...

Decoding FDA Guidance on Decentralized Trials     Last month the FDA released its draft guidance...

Data-driven Surgery: The Next Step in Improving Care and Operational Efficiency     At every stage...

Market Forecasting: Solving the Problems of Too Little or Too Much Data     Reaching new...

Researchers at Rockefeller University have developed a cell culture platform in which to grow ‘lung...

Researchers at the University of Pennsylvania have developed nanorobots that can travel to the site...

For those who are regular followers of what FDA’s Office of Prescription Drug Promotion (OPDP)...

Advancing Digital Health: Huma SaMD Platform Gains U.S. Clearance     This week Huma Therapeutics received...

FDA Releases Final Guidance on Premarket Submissions for Device Software Functions     The FDA has...

Leveraging AI & ML in MedTech: ML vs. Traditional Algorithms     Many applications in health...

Risk-Based CSA Validation: Ensuring the Least Burdensome Approach     Now that the FDA guidance on...

The human body has a deep connection with electricity. The transmission of electrical impulses is...

Engineers at the University of California San Diego have developed a low-cost cuffless blood pressure...

Researchers at George Washington University have created a swallowable capsule containing a video camera that...

Engineers at the University of Colorado at Boulder have developed a medical microrobot that is...

The iLet Bionic Pancreas for use by type 1 diabetes patients has been cleared by...

Researchers at the Ohio State University Wexner Medical Center have developed a medical device that...

Facilitating Connections with MedTech KOLs     Input and support from experts within your target disease...

Researchers at the University of California San Diego have created a wearable ultrasound system that...

Engineers at Ecole Polytechnique Fédérale de Lausanne (EPFL) in Switzerland have developed a new technology...

Scientists at Purdue University have developed a urine test for early-stage Parkinson’s disease. The technology...

Using RTLS To Improve Operational Efficiency     Medical professionals are facing an unprecedented challenge in...

FDA Announces Additional Steps to Modernize Clinical Trials     On June 6, the FDA released...

Researchers at Penn State have developed a low-cost, wearable sensor using pencil-on-paper technology. This approach...

Researchers at Florida State University have developed a 3D model that examines how the bacterium...

AAMI and BSI Partner to Publish Guidance on Artificial Intelligence     The Association for the...

Leveraging AI & ML in MedTech: Purpose-Built Applications     A Venture Capitalist recently joked that...

Beyond EU MDR: Unleashing Opportunities to Innovate and Ensure Patient Safety     A harmonious blend...

Researchers at MIT have developed smart sutures with a hydrogel coating that contains sensing and...

Researchers at UMass Chan Medical School have developed a small interfering RNA (siRNA) technology that...

FDA Offers Funding for Adoption of Advanced Manufacturing Technologies     Medical device manufacturers that are...

Researchers at the Hubrecht Institute in the Netherlands have developed a biobank of cancer organoids...

FDA CDRH Portal Now Offers Tracking of Pre-Submissions     On May 22, the FDA announced...

Developing Sustainable Medical Devices     Device Talks Boston in May featured a panel, “Past Due:...

Wearable Design Challenge: Stick-to-Skin Adhesion     Wearable device engineers are working miracles in wringing more...

<!– Medical Innovation Exchange May 23, 2023 7:49 am https://www.medgadget.com/2023/05/automated-computer-assistant-for-kidney-transplant-rejection-diagnostics-interview-with-study-authors.html

Researchers at the University of Göttingen in Germany have developed a cell culture chamber that...

Researchers at Ecole Polytechnique Fédérale de Lausanne (EPFL) in Switzerland have developed a soft robotic...

Researchers at the University of Colorado at Boulder and the National Institute of Standards and...

Researchers at MIT have developed a method that allows them to analyze the three dimensional...

Scientists at the University of Minnesota have developed a method to detect misfolded proteins more...

Scientists at the Japan Advanced Institute of Science and Technology in Ishikawa, Japan have developed...

Student researchers at Rice University have developed a paper strip test for hypothyroidism, similar to...

Researchers at the University of Illinois at Urbana-Champaign have developed a bioinspired implant coating that...

Researchers at Ecole Polytechnique Fédérale de Lausanne (EPFL) in Switzerland have created a machine learning...

Researchers at the University of Hawaii at Manoa have developed a wearable that can take...

Smart Hospitals: Five Technologies Upgrading the Industry     Smart hospitals are working to provide patients...

Automating Computer Systems Validation for Your QMS      Companies must show that their software systems...

FTC Sues to Block Amgen Acquisition of Horizon Therapeutics     On May 16, the Federal...

President Biden To Nominate Monica Bertagnolli, MD, as Director of NIH     On May 15, President...

Researchers at Northwestern University have trailed an implanted ultrasound device in patients, which is used...

Researchers at the University of California San Diego have developed a wearable ultrasound patch that...

Researchers at ETH Zurich in Switzerland have developed a high-throughput screening method for anti-cancer drugs...

Researcher scientists at the University of Texas at Austin have developed a brain decoding technology...

FDA Releases Two Discussion Papers on Artificial Intelligence and Machine Learning in Drug Development and Manufacturing...

Researchers at the University of Texas at Austin have developed a new chest wearable that...

FDA Issues Draft Guidance on Use of Decentralized Clinical Trials     The FDA has published...

Researchers at MIT have developed an ‘electroceutical’ capsule that is designed to be swallowed and...

<!– Medical Innovation Exchange May 9, 2023 1:23 pm https://www.medgadget.com/2023/05/rf-technology-for-health-monitoring-michael-leabman-cto-of-movano-health.html

Researchers at the University of Birmingham in the United Kingdom have developed a microfluidic device...

Researchers at MIT have developed a urine test that can distinguish between different types of...

How to Boost Patient Confidence Through Medical Device Design     Medtech manufacturers are working with...

A team of medical engineers at Cornell University has developed a knitted glove that is...

Researchers at Houston Methodist have developed an implant that can provide localized and sustained release...

<!– Medical Innovation Exchange May 8, 2023 12:36 pm https://www.medgadget.com/2023/05/antibiotic-susceptibility-testing-using-simple-microscope-and-smartphone.html

The Role of 3D Micro Printing in Device Development     As 3D printing gains a...

<!– Medical Innovation Exchange May 3, 2023 9:28 am https://www.medgadget.com/2023/05/ais-role-in-healthcare-exclusive-interview-with-catherine-estrampes-president-ceo-at-ge-healthcare.html

Researchers at MIT have developed a printer that can create large numbers of microneedle patch-style...

Researchers at MIT have developed a nanoparticle system that is designed to deliver immunostimulatory drugs...

What’s Happening in the UK and Switzerland     The implementation and extensions of EU MDR/IVDR...

Implementing MedTech Price Increases in Times of Inflation and EU MDR     Steadily high inflation...

<!– Medical Innovation Exchange May 2, 2023 7:14 am https://www.medgadget.com/2023/05/digital-self-neuromodulation-therapy-for-ptsd-interview-with-oded-kraft-ceo-of-graymatters-health.html

Researchers at the Harvard Wyss Institute have developed a new type of cell therapy for...

Researchers at Rice University have developed a “Stimu Sock” that can help to treat balance...

Engineers at MIT have developed a patch that uses ultrasound to deliver drugs through the...

Researchers at Northwestern University and the University of Texas at Austin have developed a thin...

Researchers at Linköping University in Sweden created a wound dressing that can provide a visual...

In today’s Federal Register, the agency has announced that the Office of Prescription Drug Promotion...

Researchers at Penn State have engineered a rapid testing technology for mpox, previously known as...

Researchers at Chalmers University of Technology in Sweden have developed a microfluidic system to test...

CDRH Announces Radiation Sterilization Pilot Program     On the heels of the EPA’s announcement of...

Software and Artificial Intelligence as a Medical Device     Earlier this month, the UK Medicines...