FDA designates devices for heart surgery, smart knee implant as ‘breakthroughs’
The program gives manufacturers better access to regulators and the ability to design more flexible clinical trials.
Elon Musk’s Neuralink brain chip receives FDA’s ‘breakthrough device’ status — and could help blind people see again
Elon Musk’s brain chip firm Neuralink has received “breakthrough device” status for an implant aimed at helping blind patients regain their sight, the firm announced. Dubbed “Blindsight,” the experimental brain implant gained clearance from the US Food and Drug Administration to participate in the voluntary program.
Neuralink says the FDA designated its Blindsight implant as a 'breakthrough device'
Neuralink says the Food and Drug Administration has designated its experimental Blindsight implant as a "breakthrough device." The company is developing the technology in an attempt to restore blind people's sight.
Neuralink Wins ‘Breakthrough Device’ FDA Approval for Tackling Blindness
The regulatory approval is just the first phase of a long project, but Neuralink owner Elon Musk is already touting his brain implant tech as a world-changing solution for people with vision loss.
Neuralink's Blindsight gets FDA approval for testing
T-Mobile is making a bold move into AI in 2024, partnering with OpenAI to revolutionize how it handles customer support.
Elon Musk’s Neuralink wins FDA breakthrough tag for Blindsight device
Elon Musk-owned neurotechnology firm Neuralink has received the U.S. FDA’s breakthrough device designation for its brain implant, Blindsight. Read more here.
Medical Device Manufacturers Fail To Make The Grade On Cybersecurity
It’s not a time to do the minimum. Medical device cybersecurity is volatile and constantly changing, so your strategy must be ...
Medical Moment: Pros and cons of smart devices
New research shows the pros and the cons of smart devices. From steps and calories to heartbeats and ZZ’s, your smart watch ...
Medical AI could be great. But the way we are regulating it now is dangerous
In this edition...what's wrong with the way we regulate medical AI and how one startup plans to fix it; OpenAI rolls out its ...
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What lies ahead for New Zealand’s medical device market?
A shift in policy involves decreased funding for digital health, impacting the sector’s growth. The growth of New Zealand’s ...
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How HHS aims to keep AI-enabled medical devices working as they should
The DA has approved nearly a thousand AI-enabled medical gadgets. The question must be asked of how to keep these devices working properly over time.
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Think of the New Apple AirPods and Watch As Medical Devices
This sort of comprehensive body tracking was, when the Apple Watch first launched, both technologically infeasible and well ...
Doctors overwhelmed by blast injuries as civilian impact of device explosions sparks outcry
The pagers and walkie-talkies were used by Hezbollah, which has exchanged months of escalating fire and threats with Israel that have displaced and killed civilians on both sides of the border — but ...
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AI’s growing influence on the medical device company’s value chain
With the rise of interest around AI since the release of large language models (LLMs), there is pressure on MedTech executives to get ahead of industry peers regarding AI, not only within devices but ...
SAPD officer shoots woman waving gun and pointing it at police in Medical Center area, Chief McManus says
SAN ANTONIO — A woman was hospitalized after pointing a gun at police and drawing the fire of one officer, resulting in her ...
E&E3d
Washed-up medical waste closes beaches in 3 states
Syringes, needles and other potentially harmful medical devices were found Sunday morning largely along Assateague Island ...
Pediatric Medical Device Market Is Expected To Reach Revenue Of USD 70.3 Bn By 2033, At 8.1% CAGR: Dimension Market Research.
Advancements and Projections in the Pediatric Medical Device Market: Insights, Trends, Opportunities, and Recent ...