…cybersecurity, allowing manufacturers who have made security upgrades on devices to have a streamlined regulatory approval process on the upgraded device. This is good news, but companies will still need…
…cybersecurity, allowing manufacturers who have made security upgrades on devices to have a streamlined regulatory approval process on the upgraded device. This is good news, but companies will still need…
From intelligent prosthetics embedded with sensors to cuff-less blood pressure monitoring to smart patches, wearable technology continues to make leaps and bounds. This article briefly reviews a few examples of…
From intelligent prosthetics embedded with sensors to cuff-less blood pressure monitoring to smart patches, wearable technology continues to make leaps and bounds. This article briefly reviews a few examples of…
…contains the entire contents of the Audit Model and adds some guidance for the auditors. More good news: You don’t necessarily need to worry about total compliance for all five…
…contains the entire contents of the Audit Model and adds some guidance for the auditors. More good news: You don’t necessarily need to worry about total compliance for all five…
In addition to all the bells and whistles that come with an Apple Watch, the Series 4 product has received FDA clearance—specifically De Novo classification. Unveiled at an Apple event…
In addition to all the bells and whistles that come with an Apple Watch, the Series 4 product has received FDA clearance—specifically De Novo classification. Unveiled at an Apple event…
FDA has awarded up to $6 million in grants to support the development of pediatric medical devices. The awards are in the form of five grants that will be distributed…
FDA has awarded up to $6 million in grants to support the development of pediatric medical devices. The awards are in the form of five grants that will be distributed…
With Labor Day behind us, the traditional American summer has come and gone. Despite the light reading that many summer lovers seek, the audience of MedTech Intelligence was interested in…
With Labor Day behind us, the traditional American summer has come and gone. Despite the light reading that many summer lovers seek, the audience of MedTech Intelligence was interested in…
This week Alcon announced the withdrawal of all versions of the CyPass Micro-Stent from the worldwide market. The move was made after the company analyzed five-year data from the COMPASS-XT…
This week Alcon announced the withdrawal of all versions of the CyPass Micro-Stent from the worldwide market. The move was made after the company analyzed five-year data from the COMPASS-XT…
…is available on the Pediatric Device Innovation Symposium’s website. The competition will be held on September 23, and the symposium will be co-located with The MedTech Conference in Philadelphia. https://medtechintelligence.com/news_article/cardboard-incubator-gives-preemies-better-chance-survival/…
…is available on the Pediatric Device Innovation Symposium’s website. The competition will be held on September 23, and the symposium will be co-located with The MedTech Conference in Philadelphia. https://medtechintelligence.com/news_article/cardboard-incubator-gives-preemies-better-chance-survival/…
Every day, we are being bombarded by news of cyberattacks and breaches of our national critical infrastructure—which includes our healthcare system and the connected technologies that are now associated with…
Every day, we are being bombarded by news of cyberattacks and breaches of our national critical infrastructure—which includes our healthcare system and the connected technologies that are now associated with…
This week FDA released the new figures for medical device user fees, annual establishment registration fees, and small business designation and fees for FY 2019 (October 1, 2018–September 30, 2019)….
This week FDA released the new figures for medical device user fees, annual establishment registration fees, and small business designation and fees for FY 2019 (October 1, 2018–September 30, 2019)….
