FDA

CDRH Releases Update on Actions Related to Philips Respironics 2021 Recall

By MedTech Intelligence Staff

In June 2021, Philips Respironics issued a voluntary recall for specific ventilators, bi-level positive airway pressure and continuous positive airway pressure machines due to device breakage that could lead to…

In June 2021, Philips Respironics issued a voluntary recall for specific ventilators, bi-level positive airway pressure and continuous positive airway pressure machines due to device breakage that could lead to…

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Kristen Hanich, Parks Associates
Soapbox

Telehealth Among Seniors: Drivers for Remote Care

By Kristen Hanich

…and local services are more comparably used. Telehealth service providers with a direct-to-consumer strategy are best served targeting younger consumers to grow their user base. Older consumers are less likely…

…and local services are more comparably used. Telehealth service providers with a direct-to-consumer strategy are best served targeting younger consumers to grow their user base. Older consumers are less likely…

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Alert

Medtronic Recalls Harmony Delivery Catheter Due to Risk of Capsule Breakage During Use

By MedTech Intelligence Staff

…The Class I recall affects 665 devices in the United States. There have been six complaints and one injury related to this device issue, but no deaths have been reported….

…The Class I recall affects 665 devices in the United States. There have been six complaints and one injury related to this device issue, but no deaths have been reported….

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Wearable Cloud, Medical Device Connectivity

Virtual Event Addresses Telemedicine and Healthcare Outside of the Hospital

By MedTech Intelligence Staff

…being said, many questions remain: What does the future of telemedicine hold, and how will it change medicine and the way provider facilities operate? Will parts of healthcare become completely…

…being said, many questions remain: What does the future of telemedicine hold, and how will it change medicine and the way provider facilities operate? Will parts of healthcare become completely…

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Ames Gross, Pacific Bridge Medical
Ameing for Asia

Is China Still A Good Opportunity For Device Manufacturers?

By Ames Gross

…Chinese factories, due to COVID-19. Many Chinese factories are not currently fully staffed, and many Western medtech companies are complaining about this issue. Some device companies are looking to diversify…

…Chinese factories, due to COVID-19. Many Chinese factories are not currently fully staffed, and many Western medtech companies are complaining about this issue. Some device companies are looking to diversify…

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Harry Glorikian
Soapbox

Telemedicine Moved Forward During the Pandemic. Our Policies and Regulations Need to Catch Up

By Harry Glorikian

…latest data from McKinsey shows that utilization is now 38 times higher than pre-pandemic levels and holding strong. It’s easy to see why: Telemedicine is a convenient, cost-effective, efficient way…

…latest data from McKinsey shows that utilization is now 38 times higher than pre-pandemic levels and holding strong. It’s easy to see why: Telemedicine is a convenient, cost-effective, efficient way…

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Minnetronix Medical

Overcoming Challenges in Bringing Optical Systems to the Medical Device Market

By Matt Adams

…add a layer of complexity. Translating high precision optical designs at micron-level tolerances into viable, manufacturable commercial products requires seamless integration between their fundamental materials of glass or plastic (the…

…add a layer of complexity. Translating high precision optical designs at micron-level tolerances into viable, manufacturable commercial products requires seamless integration between their fundamental materials of glass or plastic (the…

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FDA

Risk of False Results with Certain Prenatal Genetic Screening Tests

By MedTech Intelligence Staff

…with NIPT tests that look for genetic abnormalities in a fetus via testing a blood sample, and the agency has stated that these screening tests are not diagnostic tests. “They…

…with NIPT tests that look for genetic abnormalities in a fetus via testing a blood sample, and the agency has stated that these screening tests are not diagnostic tests. “They…

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Brian Stallard, AAMI
MEDdesign

A State of Alarm: Research Advances for Medical Warning Systems

By Brian Stallard

validated to improve the detective value of monitoring devices,” the authors wrote. “Once replicated and validated, vendors are encouraged to work collaboratively with other stakeholders to integrate AI-based, multivariate-alarm-detection algorithms…

validated to improve the detective value of monitoring devices,” the authors wrote. “Once replicated and validated, vendors are encouraged to work collaboratively with other stakeholders to integrate AI-based, multivariate-alarm-detection algorithms…

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authentication, QR code

Patient-Operated Devices Are Changing the Healthcare Landscape

By Philip Remedios

…the comfort of their own homes. It is no surprise, therefore, that patient-administered healthcare is one of the fastest-growing segments in the medtech industry, with an estimated CAGR of 12.5%…

…the comfort of their own homes. It is no surprise, therefore, that patient-administered healthcare is one of the fastest-growing segments in the medtech industry, with an estimated CAGR of 12.5%…

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