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Implant shows potential as opioid alternative: Nerve-Cooling Implant Could Ease Pain Without Opioids

Hinting at a future alternative to opioid painkillers, scientists have developed a tiny implant designed to ease post-surgery pain and then dissolve once the job is done.

E-nose designed to diagnose Parkinson's disease by smelling skin

Currently, Parkinson’s Disease (PD) diagnosis is mainly based on medical history and physical examination, and there is no objective and consistent basis. By the time of diagnosis, the disease would have progressed to the middle and late stages that it’s difficult to treat. Although there’s no cure, early diagnosis and treatment can improve one’s quality of life, relieve symptoms and prolong survival.

Artificial Intelligence (AI) Algorithms Help Guide Decisions In Palliative Care

How machine learning is influencing "The Conversation" - Artificial intelligence (AI) is beginning to affect every aspect of our lives, including when physicians should have the conversation broaching palliative care with patients.  Machine learning, a type of AI, uses statistical models and algorithms to recognize data patterns and make predictions on behalf of doctors.  But how accurate is it?

Plans underway to ramp up monkeypox testing if outbreak grows quickly

As more cases are uncovered in a global monkeypox outbreak, biotech companies and health officials are looking to make PCR testing for the virus more widely available in the US.

Artificial Intelligence (AI) Device May Help Diagnose Children's Autism in Primary Care Settings

A new study shows that implementing an artificial intelligence-based medical device in primary care settings can help clinicians accurately diagnose autism spectrum disorder in children.

FDA guidances for medical device regulation after enforcement discretion and EUA expiration
This article summarizes the requirements for transitioning medical devices, marketed with lowered standards for effectiveness under emergency use authorization (EUA) during the COVID-19 pandemic, after the EUA declaration expires.  These policies may evolve as the US Food and Drug Administration (FDA) awaits declaration from the secretary of Health and Human Services (HHS) stating that the pandemic has ended.  The author suggests this limited oversight of the manufacture of medical devices and the lowered expectations for device effectiveness may affect future requirements for objective evidence for marketing submissions after EUAs have been terminated and diagnostics for COVID-19 undergo increased scrutiny by the Agency for marketing authorization.  The scope of this article covers medical devices with published enforcement discretion policies from the FDA and those authorized under EUAs during the COVID-19 public health emergency.
Cochlear Implants Beneficial for Deafness and Developmental Delays

Gains in cognitive skills and adaptive function appear to be slower for children with low cognition and low adaptive behavior with hearing aids versus implants

Medtech groups want more time to implement FDA's QMSR rule

Medical device lobby groups say they support the US Food and Drug Administration’s plan to align its Quality System Regulations (QSR) with the international quality system standard, but they want more than a year to make the transition.

A call to action for treating uterine fibroids

A call to action in the journal Reproductive Sciences hopes to empower health care providers to optimize their quality of care for women with uterine fibroids by relying on the best available evidence and best patient-centered practices.

"Smart" pacifier could improve care of premature babies in Neonatal Intensive Care Unit (NICU)
Babies who are in the neonatal intensive care unit or NICU are at risk for dehydration and electrolyte imbalances and are therefore often subjected to blood draws multiple times a day.  A wireless, bioelectronic pacifier could eliminate the need for invasive, twice-daily blood draws to monitor babies’ electrolytes in NICUs.
AdvaMed joins Biden's Joint Supply Chain Resilience Working Group

AdvaMed executive Abby Pratt has joined the Executive Committee for the Biden Administration’s Joint Supply Chain Resilience Working Group, the MedTech industry association said in mid-May 2022.

Google Health hires FDA's Chief Digital Health Officer
Former FDA Chief Digital Health Officer of Global Strategy and Innovation Bakul Patel has started a new job with Google after 13 years with the regulatory agency
Study says Diadem blood test accurately predicts Alzheimer's disease progression

Data from a clinical validation study published in the Journal of Prevention of Alzheimer’s Disease (AD) show that Diadem's AlzoSure Predict Alzheimer's disease blood test was able to accurately predict the progression of the disease.  The researchers compared the test, which has been designated a breakthrough device by the FDA, with gold-standard amyloid beta-PET imaging.

The half-hour superbug test 'that will save thousands of lives on wards' by rapidly discovering if the infection is resistant to powerful antibiotics

In England, 5,000 patients die each year from antibiotic-resistant super bugs.  Scientists at Imperial College London have developed a new rapid diagnosis test.  Superbugs spread rapidly and often kill patients admitted for minor problems.

FDA recommends sponsors plan to include race, ethnicity in clinical trial design

The US Food and Drug Administration (FDA) is recommending sponsors include a plan to increase diversity when proposing clinical trial designs for investigational products to Agency reviewers.  The move is part of the Biden administration’s focus on addressing racial and ethnic disparities in health care.

Researchers develop Artificial Intelligence (AI) guided handheld catheter surgical robot placement device which could automate catheter placement

Researchers at the Massachusetts Institute of Technology’s (MIT) Lincoln Laboratory have developed an artificial intelligence-guided ultrasound device to help physicians quickly deploy a catheter at a point of injury.

New mobile low-field MRI scanner inches closer to increasing imaging access in rural communities

Experts are on the cusp of breaking access barriers with the development of mobile magnetic resonance imaging.

FDA cannot explain record-low medical device recalls

Medical device product recalls were down 14.3% in the federal government’s fiscal year 2021, according to a recent Medical Design & Outsourcing (MDO) analysis of recall data.

Today's Top Medical Device Security Challenges, Mitigation Strategies

Collaboration, communication, and education can help healthcare organizations manage medical device security challenges and ensure patient safety.

Electrochemical Test Measures Antibiotic Resistance
Researchers at Washington State University have developed an electrochemical test that can rapidly identify antibiotic-resistant bacteria in patient samples.

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