#medical-devices

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How to Create Effective Instructions for Use | ClickUp

Clear Instructions for Use (IFU) are crucial to avoid user frustration and ensure safety, particularly in high-risk industries like medical devices.
#business-strategy

Its stock is up 50 percent. Billion-dollar deals for breakfast. How did Boston Scientific get its mojo back?

Boston Scientific has successfully recovered and transformed from past failures through strategic acquisitions and effective leadership, culminating in a $130 billion valuation.

Philips new CEO is overhauling company culture and adding a role to the C-suite

Royal Philips emphasized patient safety post-recall by establishing a new C-suite role and fostering a culture of openness and responsibility.

Its stock is up 50 percent. Billion-dollar deals for breakfast. How did Boston Scientific get its mojo back?

Boston Scientific has successfully recovered and transformed from past failures through strategic acquisitions and effective leadership, culminating in a $130 billion valuation.

Philips new CEO is overhauling company culture and adding a role to the C-suite

Royal Philips emphasized patient safety post-recall by establishing a new C-suite role and fostering a culture of openness and responsibility.
morebusiness-strategy

Horrifying medical device malfunction: Abdominal implant erupts from leg

The case highlights concerns over the safety and transparency of IVC filter devices after a patient experienced severe complications from a failed filter.
#patient-care

From AI to Musk's Brain Chip, the F.D.A.'s Device Unit Faces Rapid Change

Advancements in medical devices significantly impact patient care, prompting increased regulatory scrutiny by the FDA.

FDA's promised guidance on pulse oximeters unlikely to end decades of racial bias

Pulse oximeters show racial bias, with readings less reliable for Black patients, leading to delayed treatments and worsening health outcomes.

From AI to Musk's Brain Chip, the F.D.A.'s Device Unit Faces Rapid Change

Advancements in medical devices significantly impact patient care, prompting increased regulatory scrutiny by the FDA.

FDA's promised guidance on pulse oximeters unlikely to end decades of racial bias

Pulse oximeters show racial bias, with readings less reliable for Black patients, leading to delayed treatments and worsening health outcomes.
morepatient-care
#startups

Endless possibilities of a digital stethoscope

Lapsi Health's innovative digital stethoscope aims to improve patient care through technology integration in medical devices.

Level Zero Health is working on a potentially life-changing device for hormone health | TechCrunch

Level Zero Health aims to develop a continuous hormone monitoring device, potentially transforming hormone health similar to CGMs for diabetes.

Endless possibilities of a digital stethoscope

Lapsi Health's innovative digital stethoscope aims to improve patient care through technology integration in medical devices.

Level Zero Health is working on a potentially life-changing device for hormone health | TechCrunch

Level Zero Health aims to develop a continuous hormone monitoring device, potentially transforming hormone health similar to CGMs for diabetes.
morestartups
#fda-approval

Elon Musk's Neuralink brain chip receives FDA's 'breakthrough device' status - and could help blind people see again

Neuralink's Blindsight implant has been approved to assist blind patients, even those blind from birth, in regaining their sight.

Calming Tremors

The GyroGlove is a groundbreaking device for stabilizing hands affected by essential tremors, significantly improving users' quality of life.

Elon Musk's Neuralink brain chip receives FDA's 'breakthrough device' status - and could help blind people see again

Neuralink's Blindsight implant has been approved to assist blind patients, even those blind from birth, in regaining their sight.

Calming Tremors

The GyroGlove is a groundbreaking device for stabilizing hands affected by essential tremors, significantly improving users' quality of life.
morefda-approval

Apple wins a battle (and $250) in its smartwatch patent fight with Masimo

Apple won a patent infringement case against Masimo but received only $250 in damages, reflecting the intricacies of patent law.
#healthcare

The Importance of Implementing Explainable AI in Healthcare

Explainable AI (XAI) is essential in healthcare for accurate diagnoses and treatment.
XAI has use cases in medical devices, patient analytics, and medical research.

14,000 medical devices are online, unsecured and vulnerable

Nearly half of the world's exposed medical devices are located in the U.S., highlighting significant cybersecurity vulnerabilities in the healthcare sector.

How Philips CEO Roy Jakobs is turning the company around after a major recall

Philips is focusing on healthcare innovations and leveraging AI to redefine its business model for the future.

FDA Names a New Chief of Medical Devices

Dr. Michelle Tarver begins her new role at the FDA to strengthen safety standards and restore credibility regarding medical device regulation.

US FDA issue warning over smartwatches and smart rings

Consumers should not use smart devices to manage blood glucose without skin piercing
FDA emphasizes the importance of using FDA-approved devices for accurate blood glucose measurements.

The Importance of Implementing Explainable AI in Healthcare

Explainable AI (XAI) is essential in healthcare for accurate diagnoses and treatment.
XAI has use cases in medical devices, patient analytics, and medical research.

14,000 medical devices are online, unsecured and vulnerable

Nearly half of the world's exposed medical devices are located in the U.S., highlighting significant cybersecurity vulnerabilities in the healthcare sector.

How Philips CEO Roy Jakobs is turning the company around after a major recall

Philips is focusing on healthcare innovations and leveraging AI to redefine its business model for the future.

FDA Names a New Chief of Medical Devices

Dr. Michelle Tarver begins her new role at the FDA to strengthen safety standards and restore credibility regarding medical device regulation.

US FDA issue warning over smartwatches and smart rings

Consumers should not use smart devices to manage blood glucose without skin piercing
FDA emphasizes the importance of using FDA-approved devices for accurate blood glucose measurements.
morehealthcare
#healthcare-innovation

Would YOU let a robot check your breasts? Bot could diagnose cancer

The developed robotic finger enhances early detection of breast cancer and improves patient comfort during examinations.

Top 5 Breakthrough Medical Technologies You Need To Know About - Yanko Design

Preparedness and innovation are key in enhancing healthcare and managing medical emergencies.

Would YOU let a robot check your breasts? Bot could diagnose cancer

The developed robotic finger enhances early detection of breast cancer and improves patient comfort during examinations.

Top 5 Breakthrough Medical Technologies You Need To Know About - Yanko Design

Preparedness and innovation are key in enhancing healthcare and managing medical emergencies.
morehealthcare-innovation
#ai-in-healthcare

Dutch startup targets remote patient monitoring with its smart stethoscope

Lapsi Health launches Keikku, a digital stethoscope, enhancing diagnostics with AI-enabled insights by listening to body sounds.

A Healthy Dose of AI

AI transforming medical devices for enhanced diagnostics
The need to address structural inequities in healthcare alongside AI implementation

Can AI detect skin cancer? FDA authorizes use of device to help doctors identify suspicious moles.

The FDA has authorized an AI-powered medical device to help detect skin cancer
The AI device analyzes spectral data to provide real-time assessments of lesions

Dutch startup targets remote patient monitoring with its smart stethoscope

Lapsi Health launches Keikku, a digital stethoscope, enhancing diagnostics with AI-enabled insights by listening to body sounds.

A Healthy Dose of AI

AI transforming medical devices for enhanced diagnostics
The need to address structural inequities in healthcare alongside AI implementation

Can AI detect skin cancer? FDA authorizes use of device to help doctors identify suspicious moles.

The FDA has authorized an AI-powered medical device to help detect skin cancer
The AI device analyzes spectral data to provide real-time assessments of lesions
moreai-in-healthcare
#fda

Lawmakers Seek Inquiry of F.D.A. Device Chief's Potential Conflicts

Concerns over potential conflicts of interest regarding FDA's Dr. Jeffrey Shuren's role and his wife's position in medical device law.

He Regulated Medical Devices. His Wife Represented Their Makers.

Dr. Jeffrey E. Shuren's FDA career was marked by both record device approvals and significant ethical concerns due to his industry's connections.

The FDA calls them recalls,' yet the targeted medical devices often remain in use

The term 'recall' can be misleading as it may not mean removal from usage, potentially endangering public safety.

Lawmakers Seek Inquiry of F.D.A. Device Chief's Potential Conflicts

Concerns over potential conflicts of interest regarding FDA's Dr. Jeffrey Shuren's role and his wife's position in medical device law.

He Regulated Medical Devices. His Wife Represented Their Makers.

Dr. Jeffrey E. Shuren's FDA career was marked by both record device approvals and significant ethical concerns due to his industry's connections.

The FDA calls them recalls,' yet the targeted medical devices often remain in use

The term 'recall' can be misleading as it may not mean removal from usage, potentially endangering public safety.
morefda

Helmet helps mitigate hair loss for cancer patients undergoing chemotherapy - Yanko Design

The Luminate Lily helmet helps prevent hair loss during chemotherapy by blocking drugs from hair follicles, addressing a significant concern for cancer patients.

I tested a 600 ear-zapping device - and it boosted my memory by 80%

The Nurosym vagus nerve stimulation device may significantly enhance short-term memory and provide a range of health benefits by stimulating the vagus nerve.

Munich-based Symphera bags 2.4M to simplify laparoscopic surgical workflows - Silicon Canals

Symphera has raised €2.4M in seed funding to develop surgical systems that automate tool-switching in laparoscopic procedures.

The AlleyWatch Startup Daily Funding Report: 7/26/2024

NYC startups Voom Medical Devices and Photon Health secured funding: $11.2M and $7.35M respectively.

1.5 million adult bed rails are recalled following 2 reports of entrapment deaths

Recall of 1.5 million Medline Bed Assist Bars in the U.S. and Canada due to entrapment hazards and two reported deaths.

Neuralink rival sets brain-chip record with 4,096 electrodes on human brain

Precision Neuroscience sets world record with 4,096 electrodes on a living human's brain, focusing on safety and precision in brain-computer interface technology.

This wearable device is the most scientifically effective way to treat knee pain - Yanko Design

Combination of heat, light, massage for knee pain relief
Kneeflow promotes healing without chemicals or prescription

pneumatic robotic glove aids training for stroke and hand disability rehabilitation

Robotic glove for hand rehabilitation by IDC and XFT Medical uses EMG feedback and flexible robotics.
Six training modes cater to various needs, promoting muscle strengthening and motor skill improvement.

Medical device bias needs immediate action - review

Immediate action needed to address biases in medical devices, especially for darker skin tones
Recommendations include design of fairer devices and acceptance of report's conclusions by government

Earlybird Health closes twice-larger second fund, will write bigger checks | TechCrunch

Earlybird Health has closed its second fund at €173 million, more than double the size of its first healthcare-focused fund.
The fund will enable Earlybird Health to write larger checks and invest in European healthtech startups.

EU countries vote unanimously to approve AI Act

EU member countries have unanimously voted to advance the Artificial Intelligence Act, bringing new rules for governing AI.
Germany initially had reservations about the bill, but reached a compromise after clarifying that it does not apply to AI in medical devices.

Artificial muscle device produces force 34 times its weight

Researchers have developed a fluid switch using ionic polymer artificial muscles that operates at ultra-low power and produces a force 34 times greater than its weight.
The artificial muscle is composed of metal electrodes and ionic polymers, and it generates force and movement in response to electricity.

From Dr. Oz to heart valves: A tiny device charted a contentious path through the FDA

MitraClip, invented by Mehmet Oz, revolutionized cardiac treatment but faced safety concerns post-FDA approval, raising questions about regulatory oversight and industry practices.

Oregon Department of Corrections ends practice of charging prisoners for medical devices

The Oregon Department of Corrections stopped making prisoners pay for medical devices, reimbursing thousands after legal actions.
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