F.D.A. Reinstates Fired Medical Device, Food and Legal StaffersFDA has recalled many specialized employees involved in food safety and medical device review after recent layoffs.
FDA staff reviewing Musk's Neuralink among latest federal firings, sources sayFDA layoffs affect the review process for Neuralink's brain-computer interface device applications.
Lawmakers warn of impact HHS firings will have on medical device cybersecurity effortsTrump administration's layoffs at HHS raise concerns over medical device cybersecurity efforts during congressional hearings.
FDA-Approved Artificial Blood Vessel Stirs ConcernsFDA approved Humacyte's lab-grown blood vessels despite serious patient complications, raising concerns about study validation and patient safety.
Pulse oximeters may misread oxygen levels in people of color. The FDA wants to change thatThe FDA proposes extra data requirements for pulse oximeter efficacy in patients of color due to racial biases in medical technology.
Lawmakers Seek Inquiry of F.D.A. Device Chief's Potential ConflictsConcerns over potential conflicts of interest regarding FDA's Dr. Jeffrey Shuren's role and his wife's position in medical device law.
F.D.A. Reinstates Fired Medical Device, Food and Legal StaffersFDA has recalled many specialized employees involved in food safety and medical device review after recent layoffs.
FDA staff reviewing Musk's Neuralink among latest federal firings, sources sayFDA layoffs affect the review process for Neuralink's brain-computer interface device applications.
Lawmakers warn of impact HHS firings will have on medical device cybersecurity effortsTrump administration's layoffs at HHS raise concerns over medical device cybersecurity efforts during congressional hearings.
FDA-Approved Artificial Blood Vessel Stirs ConcernsFDA approved Humacyte's lab-grown blood vessels despite serious patient complications, raising concerns about study validation and patient safety.
Pulse oximeters may misread oxygen levels in people of color. The FDA wants to change thatThe FDA proposes extra data requirements for pulse oximeter efficacy in patients of color due to racial biases in medical technology.
Lawmakers Seek Inquiry of F.D.A. Device Chief's Potential ConflictsConcerns over potential conflicts of interest regarding FDA's Dr. Jeffrey Shuren's role and his wife's position in medical device law.
Digital thermometer concept stores pills and reminds you when to take them - Yanko DesignCombining related functions in product design can enhance user experience without overwhelming them.
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.
Top 5 Breakthrough Medical Technologies You Need To Know About - Yanko DesignPreparedness and innovation are key in enhancing healthcare and managing medical emergencies.
Level Zero Health is working on a potentially life-changing device for hormone health | TechCrunchLevel Zero Health aims to develop a continuous hormone monitoring device, potentially transforming hormone health similar to CGMs for diabetes.
The Electric Nose Frida Pro relieves infant congestion with hospital-grade snot suckingFrida Baby's new Electric NoseFrida Pro offers powerful, automatic snot extraction for infants, addressing congestion more effectively than previous versions.
Digital thermometer concept stores pills and reminds you when to take them - Yanko DesignCombining related functions in product design can enhance user experience without overwhelming them.
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.
Top 5 Breakthrough Medical Technologies You Need To Know About - Yanko DesignPreparedness and innovation are key in enhancing healthcare and managing medical emergencies.
Level Zero Health is working on a potentially life-changing device for hormone health | TechCrunchLevel Zero Health aims to develop a continuous hormone monitoring device, potentially transforming hormone health similar to CGMs for diabetes.
The Electric Nose Frida Pro relieves infant congestion with hospital-grade snot suckingFrida Baby's new Electric NoseFrida Pro offers powerful, automatic snot extraction for infants, addressing congestion more effectively than previous versions.
TI's tiny microcontroller is the world's smallest and costs less than 20 centsThe MSPM0C1104 is the world's smallest microcontroller, ideal for space-constrained applications.
FDA's promised guidance on pulse oximeters unlikely to end decades of racial biasPulse oximeters show racial bias, with readings less reliable for Black patients, leading to delayed treatments and worsening health outcomes.
Endless possibilities of a digital stethoscopeLapsi Health's innovative digital stethoscope aims to improve patient care through technology integration in medical devices.
14,000 medical devices are online, unsecured and vulnerableNearly half of the world's exposed medical devices are located in the U.S., highlighting significant cybersecurity vulnerabilities in the healthcare sector.
European Commission Publishes Action Plan on Cybersecurity of Hospitals and Healthcare ProvidersThe European Commission's Action Plan seeks to enhance cybersecurity in the healthcare sector in response to rising cyber threats.The Action Plan addresses interdependencies within the healthcare ecosystem, impacting not just providers but also pharmaceutical and medical device industries.
The Trade War Poses a Threat to Canadian Health Care | The WalrusA possible trade war could severely impact Canada's health care system through increased costs and disruption of medical device supplies.
How Philips CEO Roy Jakobs is turning the company around after a major recallPhilips is focusing on healthcare innovations and leveraging AI to redefine its business model for the future.
FDA's promised guidance on pulse oximeters unlikely to end decades of racial biasPulse oximeters show racial bias, with readings less reliable for Black patients, leading to delayed treatments and worsening health outcomes.
Endless possibilities of a digital stethoscopeLapsi Health's innovative digital stethoscope aims to improve patient care through technology integration in medical devices.
14,000 medical devices are online, unsecured and vulnerableNearly half of the world's exposed medical devices are located in the U.S., highlighting significant cybersecurity vulnerabilities in the healthcare sector.
European Commission Publishes Action Plan on Cybersecurity of Hospitals and Healthcare ProvidersThe European Commission's Action Plan seeks to enhance cybersecurity in the healthcare sector in response to rising cyber threats.The Action Plan addresses interdependencies within the healthcare ecosystem, impacting not just providers but also pharmaceutical and medical device industries.
The Trade War Poses a Threat to Canadian Health Care | The WalrusA possible trade war could severely impact Canada's health care system through increased costs and disruption of medical device supplies.
How Philips CEO Roy Jakobs is turning the company around after a major recallPhilips is focusing on healthcare innovations and leveraging AI to redefine its business model for the future.
Level Zero Health banks $6.9M to prove wearable medtech can take the strain out of hormone testing | TechCrunchLevel Zero Health seeks to innovate continuous hormone monitoring with a groundbreaking non-invasive device.
Munich-based Symphera bags 2.4M to simplify laparoscopic surgical workflows - Silicon CanalsSymphera has raised €2.4M in seed funding to develop surgical systems that automate tool-switching in laparoscopic procedures.
Leader Spotlight: Building technology to advance modern surgery, with Jonathan Conta - LogRocket BlogRobotic-assisted surgery is revolutionizing surgical approaches by enabling minimally invasive procedures that improve patient outcomes.
Munich-based Symphera bags 2.4M to simplify laparoscopic surgical workflows - Silicon CanalsSymphera has raised €2.4M in seed funding to develop surgical systems that automate tool-switching in laparoscopic procedures.
Leader Spotlight: Building technology to advance modern surgery, with Jonathan Conta - LogRocket BlogRobotic-assisted surgery is revolutionizing surgical approaches by enabling minimally invasive procedures that improve patient outcomes.
Why Validated DevOps is the Path Forward for Regulated Software - DevOps.comValidated DevOps revolutionizes medical device development by aligning speed and compliance, enhancing safety and innovation in healthcare.
Would YOU let a robot check your breasts? Bot could diagnose cancerThe developed robotic finger enhances early detection of breast cancer and improves patient comfort during examinations.
Swiss medical device company CeQur secures 116.4M - Silicon CanalsCeQur raised $120M to expand its commercial operations and enhance its insulin delivery technology for diabetes care.
Top 5 Cutting-Edge Medical Innovations That Are Enhancing Patient Care & Health Solutions - Yanko DesignA proactive approach and innovative technology are key to improving health monitoring and patient care.Groundbreaking medical innovations like wearable devices and adaptive casts are reshaping healthcare delivery.
New tongue-stimulating implant offers hope to millions with sleep apnoea in UK firstInnovative nerve stimulation device for sleep apnoea offers patients a new treatment option in the UK.
Why Validated DevOps is the Path Forward for Regulated Software - DevOps.comValidated DevOps revolutionizes medical device development by aligning speed and compliance, enhancing safety and innovation in healthcare.
Would YOU let a robot check your breasts? Bot could diagnose cancerThe developed robotic finger enhances early detection of breast cancer and improves patient comfort during examinations.
Swiss medical device company CeQur secures 116.4M - Silicon CanalsCeQur raised $120M to expand its commercial operations and enhance its insulin delivery technology for diabetes care.
Top 5 Cutting-Edge Medical Innovations That Are Enhancing Patient Care & Health Solutions - Yanko DesignA proactive approach and innovative technology are key to improving health monitoring and patient care.Groundbreaking medical innovations like wearable devices and adaptive casts are reshaping healthcare delivery.
New tongue-stimulating implant offers hope to millions with sleep apnoea in UK firstInnovative nerve stimulation device for sleep apnoea offers patients a new treatment option in the UK.
Liangxi Medical Equipment Industrial Park / UDG About StudioLiangxi Medical Industrial Park innovates industrial architecture and transportation, showcasing modern design while fostering economic development in Wuxi.
Ceramtec GMBH v. Coorstek Biocermanics LLCThe case underscores the complexity of trademark functionality doctrine in the medical device industry, particularly regarding product coloration and patent-exhaustion.
Patents as Product Liability Admissions: A Cert Petition Highlights Novel Use of Patent Filings in Whistleblower CaseMinerva Surgical's patents may reveal prior knowledge of significant safety issues with its devices, raising questions of accountability in product claims.
Ceramtec GMBH v. Coorstek Biocermanics LLCThe case underscores the complexity of trademark functionality doctrine in the medical device industry, particularly regarding product coloration and patent-exhaustion.
Patents as Product Liability Admissions: A Cert Petition Highlights Novel Use of Patent Filings in Whistleblower CaseMinerva Surgical's patents may reveal prior knowledge of significant safety issues with its devices, raising questions of accountability in product claims.
This MIT spinout wants to spool hair-thin fibers into patients' brains | TechCrunchNeuroBionics seeks to revolutionize treatment for neurological conditions through minimally invasive neuromodulation therapies using advanced materials.
Aurora Patents is Seeking a Medical Device and Software Patent Agent (Remote) - IPWatchdog.com | Patents & Intellectual Property LawThe role involves patent portfolio management for medical devices and software with a flexible remote work setup.
How the latest materials are taking biosensors to the next levelThe biosensor for newborns addresses the issue of skin sensitivity with innovative materials and design.Growing market for health sensors indicates a significant demand for advanced monitoring technology.
US medical device giant Artivion says hackers stole files during cybersecurity incident | TechCrunchArtivion's services are disrupted due to a cybersecurity incident, possibly a ransomware attack.
How to Create Effective Instructions for Use | ClickUpClear Instructions for Use (IFU) are crucial to avoid user frustration and ensure safety, particularly in high-risk industries like medical devices.
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-suiteRoyal 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-suiteRoyal Philips emphasized patient safety post-recall by establishing a new C-suite role and fostering a culture of openness and responsibility.
Horrifying medical device malfunction: Abdominal implant erupts from legThe case highlights concerns over the safety and transparency of IVC filter devices after a patient experienced severe complications from a failed filter.
From AI to Musk's Brain Chip, the F.D.A.'s Device Unit Faces Rapid ChangeAdvancements in medical devices significantly impact patient care, prompting increased regulatory scrutiny by the FDA.
Elon Musk's Neuralink brain chip receives FDA's 'breakthrough device' status - and could help blind people see againNeuralink's Blindsight implant has been approved to assist blind patients, even those blind from birth, in regaining their sight.
Calming TremorsThe 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 againNeuralink's Blindsight implant has been approved to assist blind patients, even those blind from birth, in regaining their sight.
Calming TremorsThe GyroGlove is a groundbreaking device for stabilizing hands affected by essential tremors, significantly improving users' quality of life.
Apple wins a battle (and $250) in its smartwatch patent fight with MasimoApple won a patent infringement case against Masimo but received only $250 in damages, reflecting the intricacies of patent law.
Dutch startup targets remote patient monitoring with its smart stethoscopeLapsi Health launches Keikku, a digital stethoscope, enhancing diagnostics with AI-enabled insights by listening to body sounds.
Helmet helps mitigate hair loss for cancer patients undergoing chemotherapy - Yanko DesignThe Luminate Lily helmet helps prevent hair loss during chemotherapy by blocking drugs from hair follicles, addressing a significant concern for cancer patients.
The AlleyWatch Startup Daily Funding Report: 7/26/2024NYC 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 deathsRecall 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 brainPrecision Neuroscience sets world record with 4,096 electrodes on a living human's brain, focusing on safety and precision in brain-computer interface technology.
From Dr. Oz to heart valves: A tiny device charted a contentious path through the FDAMitraClip, 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 devicesThe Oregon Department of Corrections stopped making prisoners pay for medical devices, reimbursing thousands after legal actions.