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Medical Device News

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(@at644)
Posts: 12
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Topic starter
 

I came across a discussion topic on this forum from 2021 regarding the global supply chain crisis during the COVID-19 pandemic and its recovery. The post reminded me about recent events affecting the medical device industry. Concerns over tariffs have led companies to stockpile supplies, raw materials, or equipment. H.R. 1 will also impact requirements for Medicaid as well as cut federal funding for Medicaid and the ACA which will put restrictions on healthcare facilities. The FDA has also been affected by cuts which have slowed down device approvals. What challenges or improvements have you seen recently in the industry? 

 


 
Posted : 06/09/2025 9:41 pm
 ri62
(@ri62)
Posts: 51
Trusted Member
 

Medical device news plays a vital role in the development of new medical technologies. It keeps researchers and developers informed about the latest innovations and advancements in the field. Updates on regulatory changes and industry standards are also highlighted, which ensures that devices are developed safely and remain compliant. News about clinical trials and market trends helps identify gaps and opportunities for improvement in healthcare solutions. Overall, staying up to date with medical device news supports informed decision-making, encourages innovation, and accelerates the creation of effective, patient-centered devices.


 
Posted : 07/09/2025 2:55 pm
 pz98
(@pz98)
Posts: 49
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For an improvement in the industry, I think the use of AI is showing signs that is is helping accelerate progress in medicine. On the news, I read about a medical device company which developed AI-based software for identifying ovarian cancer through the use of a blood test. It analyzes the patterns in lipids and proteins in a patient's blood and compares it with an AI model to patients with ovarian cancer and healthy patients. Apparently it has a really high accuracy and is almost always correct in identifying the cancer in very early stages. At the same time, the increasing use of AI in new medical devices presents issues on the regulatory side. If the FDA and other regulatory agencies cannot move as quick as industry, many of these projects will be stopped from progressing into the market. I believe this will be one of the challenges which become more apparent as time goes on.


 
Posted : 07/09/2025 10:48 pm
(@vanshamin)
Posts: 13
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@pz98 I agree with you that AI is one of the biggest improvements in industry. While you have brought up its use directly in medical devices and in pattern recognition in AI based software, I think AI may also have potential to be used in manufacturing of medical devices or possibly even in developing ways to scale up manufacturing of medical devices. However, as you said FDA regulations are slow to catch up especially with how quickly some AI models evolve, and misuse of AI models in medical devices, especially in GMP processes may improper regulations that could either hold back the industry, or be too lax and impact patients. I believe that using AI for manufacturing of medical devices could be a huge boon to the industry, but may also be a major hurdle for companies to navigate as it evolves.


 
Posted : 07/09/2025 11:56 pm
(@darshp)
Posts: 12
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@pz98 @vanshamin I think you guys brought up some great points about the use of AI in the medical device industry. I have read many articles and learned about how AI could effectively change factors like reducing the time for finding different diseases or irregularities. For example, one thing I learned from a course last year was the use of AI to detect tumors, specifically in MRI scans of the brain. If trained correctly, tumors could be imaged and located much faster (with relatively high accuracy). Although there are cases where AI could make mistakes or miss over things, the implementation of these types of software's could serve as a future improvement to help reduce the time for finding things like tumors. For example, just as a thought, doctors could still go through the regular procedures of imaging, but they could also run the images through a AI self-learning model and over the course of 5-10 years, with the correct processing power, it could have the potential to accurately predict the locations of certain masses (if that is the desired outcome of the imaging). It is absolutely certain that the current models would have issues and miss over things, but just in the case where a doctor might miss over something on an image and the AI detects it, it could be a good form of secondary securement for the patient since doctors can also make mistakes. Vansh, you made a good point about the misuse of AI models but I think as a secondary checking method after the primary check (the doctor), it could be helpful in finding things the doctors may have missed. In my opinion, with the rise of such technologies like AI, reducing FDA funding towards these types of things does not make sense because they could really revolutionize and reduce the cost and time for tests at hospitals (which ultimately helps with the most important thing, saving lives and detecting problems early on)


 
Posted : 08/09/2025 7:36 pm
(@kartikeyakulkarni)
Posts: 17
Active Member
 

Medical technology has experienced a major breakthrough through AI systems which now enable better disease detection at early stages. A startup company created an AI-based blood screening method which identifies ovarian cancer during its initial development stages. The test analyzes blood samples (lipid and protein) patterns through an AI system which learned from ovarian cancer and non-ovarian cancer patient data. The test achieved more than 90% accuracy during clinical trials when detecting cancers at their earliest stages which are typically the most difficult to achieve. The medical field has made a groundbreaking discovery through this technology because it enables doctors to start treatments before cancer progresses. 


 
Posted : 09/09/2025 9:22 am
(@sic23njit-edu)
Posts: 13
Active Member
 

A medical device that comes to mind in lieu of this topic would be the Acurate Heart Valve from Boston Scientific which was recently cancelled in May. An official statement regarding the cancellation of the heart valve points its cancellation to "heightened clinical and regulatory requirements." From my understanding, the medical device regulations from the FDA Post-Covid have become less tolerant of ambiguous safety signals and I assume Boston Scientific's Acurate heart valve was unable to meet those standards and with the current tariff climate, it would be hard to allocate large sum of funds to redesigning such an implant. I'm sure there are other similar examples of previously approved medical implants in Europe or the U.S. have been put through a much more strict criteria post-covid since outside of tariffs, medical devices are constantly improving, competitors are trying to one-up what already exists in market and I assume the FDA would be more likely to approve a product from a company that can prove it's efficacy, safety, and overall low mortality rates. The stricter criteria that they implement may slow down device approvals since they must undergo more safety testing and clinical trials. 


 
Posted : 09/09/2025 12:49 pm
(@agebraeil)
Posts: 13
Active Member
 

@vanshamin I completely agree that AI has completely changed the industry and how things work. I do believe that AI has made it possible to manufacture medical devices but I do agree that the FDA has made the process slower. I think that AI can completely evolve the industry and medical devices and in pharmaceutical companies I just do think the FDA needs to catch up with this quick technological world that we are living in for the industry to make these new advances. An example of a FDA approved medical device that involves AI would be Aidoc Medical which is an AI feature that can detect a collapsed lung on X-rays.


 
Posted : 09/09/2025 1:51 pm
(@agebraeil)
Posts: 13
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I think AI is one of the biggest improvements in the medical device industry. I believe that it can be used to improve accuracy and personalize treatments more efficiently. I have read that AI can identify things that are wrong in manufacturing to improve high quality standards and this has to do with quality control. I think AI is going to revolutionize the industry and make things a lot better and faster. I do believe that companies need to keep up with AI and all the upgrades that are happening.


 
Posted : 09/09/2025 8:18 pm
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