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Recently cleared by the FDA, Osteoboost is clinically proven to significantly slow bone density and strength loss through its patented precision vibration therapy, specifically targeting postmenopausal women with osteopenia.
Food and Drug Administration (FDA) for post-traumatic stress disorder (PTSD) means the drug may be rescheduled, which will lead to substantially decreased regulations attached to it. However, in 2016, DEA added some clarity to the “accepted medical use” qualification, saying that FDA approval was one way to achieve this threshold.
Food and Drug Administration (FDA) has approved the Teal Wand , marking it as the first and only at-home self-collection device for cervical cancer screening in the United States. The Teal Wand simply offers a different, FDA-approved method for collecting the sample.
An FDA announcement that semaglutide injection products, the GLP-1 medication in the blockbuster drugs Wegovy and Ozempic, are no longer in shortage. An FDA announcement that semaglutide injection products, the GLP-1 medication in the blockbuster drugs Wegovy and Ozempic, are no longer in shortage.
Abbott has received clearance from the FDA for its imaging software that uses artificial intelligence to provide doctors a better view of blood flow and blockages in heart vessels.
Cognoa, maker of the first FDA-approved autism diagnostic tool, announced Highmark has signed on as its first commercial payer partner. | The tool, Canvas Dx, leverages AI to empower doctors to quickly and accurately diagnose developmental risk without bias, the company claims. It is the first FDA-approved autism diagnostic tool.
It recently invested in Hong Kong-based health technology company Belun, which received the first United States FDA approval for an AI-powered platform for sleep apnoea diagnosis. The ring collects data which is then compiled into a clinical report for doctors who are helping manage their health.
Yet, once approved, FDA will put limits on the approved drug. The MDMA NDA Back in December 2023, Lykos Therapeutics (formerly MAPS PBC ) submitted a New Drug Application (NDA) for MDMA-assisted therapy for post-traumatic stress disorder (PTSD), which FDA recently granted priority review.
– Opill® , the first FDA-approved daily oral contraceptive available over the counter, will be the inaugural product offered through this new service. This service allows consumers to purchase eligible health products and medications directly on the GoodRx platform and have them shipped to their homes.
Food and Drug Administration (FDA) for its Smileyscope™ Therapy system. – The FDA clearance marks Smileyscope as the first and only VR Analgesic™ available in the US. The company envisions widespread adoption in hospitals, doctor’s offices, and an expanded range of patients benefiting from their drug-free treatments.
In 2022, the FDA ( Federal Food and Drug Administration ) will clear or approve over 1,000 medical devices. This is great news for patients who stand to benefit from the latest and greatest technology, but it can be tough for hospitals and doctors to keep up with all of the new devices on the market. PMA Applicant: Allergan.
Doctors’ use of and demand for augmented intelligence in medical practice is on the rise — with many factors that could bolster or risk adoption on the journey toward AI in the doctor’s office, based on the latest survey from the American Medical Association (AMA) published this week. The AMA polled U.S. First, U.S.
With this background, it’s no surprise that I was intrigued by an email I received that talked about an FDA-approved wearable for nasal congestion ( SONU is indicated for the relief of moderate to severe nasal congestion due to allergic and non allergic rhinitis. ). Turns out, I’m not alone. Their background story is interesting.
The FDA is approving digital therapeutics tools (i.e., Much like your doctor writes you a prescription for medication or physical therapy, you can now be prescribed FDA-approved digital apps. Expect a regulatory backlash to follow. Digital Therapeutics. Rejoyn, CBT-i Coach, Happify Health) at an increasing rate each year.
ActiGraft, based on RedDress’ proprietary patented technology, is an FDA-cleared wound care solution that enables health care providers to produce—in real-time—in vitro blood clots from a patient’s whole blood. The systems are expected to be delivered to Ukraine this week and could be used in the field as early as next week.
As more and more wearable devices are becoming common in the technology, they have even started to get some FDA approvals as well. Blood pressure, oxygen level, pulse rate, respiratory rate – all those things can be captured and sent back to the software system and doctors.
Before joining BCGDV, they practised as medical doctors or worked in industries such as health insurance, medtech or pharma”, the company spokesperson informed Healthcare IT News. “They represent a broad range of disciplines at Digital Ventures – from product, strategic design to engineering.
Forward Health launches staffless CarePods Forward Health, which launched its AI-driven medical concierge service in 2017, announced it will soon bring doctor-built CarePods – stand-alone medical diagnostic rooms – to major cities like San Francisco, New York and Chicago. breast screening market.
medical licensing exam , diagnose illnesses , and even outshine human doctors on measures of perceived empathy , raising many questions about how AI will reshape health care as we know it. Food and Drug Administration (FDA). In the field of medicine, ChatGPT already has been reported to ace the U.S.
Before joining BCGDV, they practised as medical doctors or worked in industries such as health insurance, medtech or pharma”, the company spokesperson informed Healthcare IT News. “They represent a broad range of disciplines at Digital Ventures – from product, strategic design to engineering.
The company says that it aggregates a care team of nurses, doctors, pharmacists, coordinators and others and partners with payers, providers and employers. Payer and healthcare systems that are Google Cloud Partners can now purchase and deploy Pager's connected care system. million remote STI testing kits it has dispatched.
LainaHealth addresses this directly by providing an initial evaluation with a dedicated Doctor of Physical Therapy (DPT) within one week. This plan is then delivered and monitored through Laina, an FDA-registered, HIPAA-compliant WebAI assistant.
It’s likely the FDA will approve a new cough drug by the end of this year – the first in more than 60 years. It will empower them to better understand their disease and communicate its severity to their doctors. It will enable providers to better diagnose, select effective therapies and monitor the course of treatment.
As the developer of the world’s first FDA-cleared online visual acuity test, Visibly is committed to growing convenient access to quality vision care nationwide. Visibly , a leading healthcare technology company, is thrilled to announce the merger of Visibly and EyecareLive. Originally announced January 18th, 2024
Instead, we should take a step back and think about how we can better support doctors in delivering high-quality care. In fact, 8 in 10 doctors believe that AI will enhance patient interactions. By narrowly concentrating on one dimension, we risk missing the myriad factors that contribute to errors.
To gauge the magnitude of this trend, consider this: as of August 7, 2024, 950 AI/ML-enabled medical devices have received clearance from the FDA , with 76% of these designed for radiology. Therefore, a doctor’s examination remains a must.
"For instance, if an individual is diagnosed with high blood pressure by a One Medical doctor, will he later be advertised over-the-counter blood pressure medications whenever he shops at Whole Foods Market?" " There are currently no FDA-approved OTC medications for hypertension.
The company labels Addison the next generation of remote patient monitoring technology that offers a solution to the caregiver shortage by providing healthcare management outside a doctor's four walls. Addison, to be released later this year, is a 3D-animated caregiver. " Numerous telehealth functions.
a large number of sperm tests are referred by doctors and specialists, but only a limited number of clinics can process them, leading to delays for patients. a large number of sperm tests are referred by doctors and specialists, but only a limited number of clinics can process them, leading to delays for patients. In the U.S.,
The tool, which has been submitted to the FDA for clearance, will initially detect abnormalities in lung exams. However, relying on such a workflow for all virtual care needs has obvious limitations, as anyone who has tried to show their doctor their tonsils via a dimly lit phone camera can tell you. " Smith said. ON THE RECORD.
Diagnostics, represented by Last Gadget Standing winner for CES 2020, MedWand — “a doctor’s visit at a patient’s fingertips” — bolstering patient engagement in-between physician visits.
Most consumers would be willing to try an FDA-approved app or online to treat a medical condition, as well as receiving hospital care at home if would be less costly. This statistic also demonstrates a new tipping point and convergence between health consumers and their doctors, which has been a chasm for a while.
Nurses are more likely than doctors to contemplate leaving their jobs , according to the 2025 Healthcare Trends Report from Qualtrics. While 70% of doctors intend to stay with their organizations for five years, only 58% of nurses intend to. Allina Health chose TytoCare to offer on-demand virtual urgent care.
many Parkinsons individuals struggle to get the guidance they need between doctor visits. Leveraging the StrivePD app and Apple Watch, coaches track FDA-cleared measures such as tremor and dyskinesia while adapting care to each patients unique disease journey. –With a shortage of movement disorder specialists in the U.S.,
PROM responses can be used for purposes of clinical care, research, quality improvement, Food and Drug Administration (FDA) approval of drugs and devices, and even insurance reimbursement. Missing data may also diminish PROM usefulness. First, not everyone who is asked to complete PROMs will be willing to do so.
FDA is currently reviewing use of Selux's NGP Gram-Negative panel. With more than 50 specialties offering more than 20,00 appointments each week, patients without health insurance can book doctors' visits for a set price with no referrals required. Inspira Technologies said it received patent approval from the U.S.
They are still waiting on FDA clearance (like most in this space), but the concept is so simple and beautiful. Of course, these companies can’t say this is what they’re able to do until they get FDA clearance, but the early results seem promising. Here’s a look at how their demo worked for me.
By implementing its strategic plan and, through its suite of solutions already cleared by the FDA, the company will support healthcare providers and clinical researchers to process an unprecedented amount of data from medical scans. Excited that Quibims AI-enabled insights from MRI, CT, and PET scans are coming to the US!
Food and Drug Administration (FDA) De Novo classification grant and authorization to market the tibial extension for Persona IQ® , the world’s first and only smart knee cleared by the FDA for total knee replacement surgery. Key information (e.g.,
Almost all of their new devices are regulated by the FDA as medical devices. “Doctors need reassurance,” he says. .” The impact can be widespread, because only 16% of people with diabetes get their annual foot exam, but the scale can identify problems with their feet early.
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