Aging in Place Technology Watch

NOVEMBER 1, 2022

What took the FDA 5 years to complete final review of essentially the same technology available in 2017, especially when they were ordered by Congress to do so? category tags: AgeTech , hearables/hearing technology , IoT and home monitoring. Now take a look at the new report The Future of Sensors and Older Adults. Feedback is welcome.

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Aging in Place Technology Watch

MARCH 12, 2022

Smart tags pinpoint not only locations of phones or keys, but persons with dementia. With the adoption of ear pods amongst the younger generation, expect hearables to further evolve, and over-the-counter hearing aid options to be FDA approved. Disruptions in the hearing technology market will persist.

Health Technology 150

Health Technology Telehealth 150

Aging in Place Technology Watch

DECEMBER 28, 2022

Congress ordered the FDA to approve this in 2017. The hearing aid manufacturers, already consolidating down to five, kept their prices so high ($3500 per uninsured ear) until 2022, while lobbying the FDA (no doubt with nit-picking detail). OTC (Over-the-Counter) Hearing Aids approved for sale direct to consumers.

Medicare 144

Medicare Interoperability Nursing 144

Aging in Place Technology Watch

JANUARY 12, 2022

But the tech has changed – now non-wearable and radar-based fall detection (even in a steam shower), tiny paper sensors in a mat , wearables that can predict the onset of stroke , ones that feature biometrics, including blood pressure , and even Air Tags or Smart Tags that can pinpoint the location of a phone (or suitcase) left behind.

Remote care 75

Remote care Digital Health Health Technology Telehealth 75

Aging in Place Technology Watch

JUNE 12, 2018

The FDA wants you to understand that it regulates hearing aids – which it defines as helping the medical condition of hearing loss. The FDA then observes “ sound amplifiers for consumers with no hearing loss who want to make environmental sounds louder for recreational use.“ category tags: hearing loss. Recreational ?

Medicare 74

Medicare 74

Aging in Place Technology Watch

APRIL 10, 2019

FDA regulations are to be delivered by August, 2020, though Bose was permitted to offer a product that will likely be the first officially FDA-approved on the market, though this audiologist’s article makes that prospect seem worrisome. But the FDA is doing nothing about insurance coverage of hearing aids.

Medicare 106

Medicare 106

Aging in Place Technology Watch

JANUARY 6, 2021

Expect hearables to further evolve; over-the-counter hearing aid purchases to be FDA-legitimized; retail and at-home self-service/self-fitting services expand (further enabled as a result of Covid-19), individuals with hearing loss may opt in to improving what they can hear in home and when out and about.

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Aging in Place Technology Watch

JANUARY 16, 2024

While Concha Labs hearing aids must be FDA approved before being sold in the United States, the combined technology and discreet profile of this product presents some exciting possibilities. category tags: AgeTech , dementia care, cognitive decline , robotics , hearables/hearing technology Learn more. Concha Labs.

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Aging in Place Technology Watch

JANUARY 10, 2023

As part of the new OTC hearing aid category and cleared by the FDA as a self-fitting hearing aid, Enhance Plus empowers millions of Americans with mild to moderate hearing loss to take the first step on their hearing health journey. Jabra Enhance Plus OTC hearing aid. " Jesse Joonho Lim, the founder of Petnow Inc. Learn more. Rise Gardens. "W

Digital Health 140

Digital Health Pain management 140

Aging in Place Technology Watch

OCTOBER 26, 2022

The FDA finally issued its approval in August 2022 for the sale of hearing aids over the counter, directly to consumers without an audiologist involved, offered through retailers like Walmart and online. category tags: AI and machine learning , hearables/hearing technology , fall prevention, fall detection , Voice/AI/Voice Assistants.

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Aging in Place Technology Watch

JANUARY 25, 2023

And the hearing technology market, first disrupted by hearables, saw its biggest disruption in 2022 – FDA approval of OTC hearing aids, driving the average price downward by as much as $3000 , driving sales online and into retail stores like Walmart. Older adults also are leaving a legacy of photos and stories for their loved ones.

Medicare 69

Medicare Telehealth Digital Health 69

Aging in Place Technology Watch

MARCH 24, 2020

Thus the FDA has expanded the ability to remotely monitor “clinical electronic thermometers, ECGs, cardiac monitors, ECG software for over-the-counter use, pulse oximeters, respiratory rate or breathing frequency monitors, non-invasive blood pressure monitors and electronic stethoscopes” used in home settings. If not now, when?

Remote care 71

Remote care mHealth Telehealth Medicare 71

Aging in Place Technology Watch

SEPTEMBER 18, 2018

In July, Tim Cook apparently did not want to get into the world of FDA regulation. In this new watch, both the ECG feature and fall detection have received FDA clearance within 30 days of applying, startling some observers who noted that closer to 150 days was more typical for a medical device.

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Aging in Place Technology Watch

JANUARY 21, 2020

Medical grade, Class II, FDA approved devices provide reliable, commonly used, clinically accurate data to share with healthcare providers. category tags: smart home , IoT and home monitoring , aging in place. Using infrared and ultra-wide band radar, we provide non-intrusive, uninterrupted monitoring. Learn more at VitalTech. .

Health Data 164

Health Data Digital Health Telehealth 164

Insulin Nation

SEPTEMBER 29, 2017

Novo Nordisk announced on September 29th, 2017 that it has received FDA market approval for its new fast-acting insulin, Fiasp*. This was the second attempt by Novo Nordisk to gain the FDA’s approval for the long-anticipated fast-acting insulin. Do you have an idea you would like to write about for Insulin Nation?

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Aging in Place Technology Watch

OCTOBER 4, 2018

In July, Tim Cook apparently did not want to get into the world of FDA regulation. In this new watch, both the ECG feature and fall detection have received FDA clearance within 30 days of applying, startling some observers who noted that closer to 150 days was more typical for a medical device. Read more here.

Medicare 94

Medicare Nursing Digital Health 94

Society for Participatory Medicine

DECEMBER 21, 2020

So, we elected to focus on testing – no reason beyond a possible common thread and the participation in our group of Michael Waters, a testing expert with the FDA. What followed was an exercise in classification, metadata, and tagging. Tagging is further search refinement. Some tags may be more useful than others.

Nursing 52

Nursing 52

Aging in Place Technology Watch

DECEMBER 17, 2019

Continuous Glucose Monitors (CGMs): Beginning in 2016, the FDA began approving Continuous Glucose Monitors. category tags: mHealth-Digital Health-Telehealth-Voice Health.

mHealth 96

mHealth Digital Health Telehealth 96

Aging in Place Technology Watch

JANUARY 13, 2021

It also features ITRI's LPMS (Low Power Microwave Sensor) technology, which passed the FDA-level electromagnetic wave radiation EMC/EMI test by the IEC60601-1/IEC60606-2 regulation." category tags: CES 2021 , Telehealth-RPM-Virtual Visits-Voice Health , Mobile PERS , hearing loss , hearables/hearing technology. Learn more at ITRI.

HIPAA 141

HIPAA Nursing Telehealth 141

Aging in Place Technology Watch

JANUARY 1, 2019

2018 was a big year for disruption in the hearing technology sector following a big change in regulatory terminology at the FDA and a win for consumers who may prefer self-service hearing tests, self-fitting of lower priced hearing aids, and self-service adjustments. Hearing technology got an upgrade and a lower price.

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Insulin Nation

JANUARY 11, 2019

dawn phenomenon. disaccharide. DIY artificial pancreas. gluconeogenesis. Glycemic Index. glycogenolysis. somatostatin. Split-Mixed. SubQ injection. T1D (Type 1 Diabetes). link] [link] . T2D (Type 2 Diabetes). link] [link] . Ultralente. Urine glucose. link] [link] . vascular system. Content of Series.

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Aging in Place Technology Watch

JUNE 25, 2018

FDA – Making the definitional matter worse. The FDA provides a guide which has no doubt worsened market confusion about PSAPs, defining their purpose “to increase environmental sounds for non-hearing impaired consumers. category tags: hearing loss , Technology - AARP. Self-care smartphone apps.

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Insulin Nation

SEPTEMBER 5, 2014

Princeton researcher Claire Gmachl has announced that her laser glucose monitor meets FDA requirements for accuracy, putting it on par with monitor devices now on the market. Although Abbott officials say they are bringing the device to the US marketplace, they didn’t share their timeline for seeking FDA approval. Treatment'

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Healthcare IT News - Telehealth

JULY 16, 2020

Mifepristone, in combination with misoprostol, is FDA-approved for abortions up to ten weeks' gestation. And abortion's price tag isn't always covered by insurance, which could put it out of reach financially. Of course, the ruling doesn't remove all barriers to abortion via telemedicine.

Telehealth 172

Telehealth Telemedicine Healthcare IT Public Health 172

Aging in Place Technology Watch

JULY 1, 2018

The FDA wants you to understand that it regulates hearing aids – which it defines as helping the medical condition of hearing loss. The FDA then observes that Personal Sound Amplification Products (PSAPs) are “ sound amplifiers for consumers with no hearing loss who want to make environmental sounds louder for recreational use.“

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Aging in Place Technology Watch

DECEMBER 31, 2019

In July, Tim Cook apparently did not want to get into the world of FDA regulation. In this new watch, both the ECG feature and fall detection have received FDA clearance within 30 days of applying, startling some observers who noted that closer to 150 days was more typical for a medical device. Don't laugh, though.

Digital Health 69

Digital Health 69

Lloyd Price

AUGUST 5, 2023

Allurion's gastric balloon is FDA-approved and has been shown to be effective in helping people lose weight. Here are some of the key takeaways from Allurion's IPO: The company's gastric balloon is a non-surgical weight loss device that is FDA-approved. Additionally, the company has been criticized for its high price tag.

Medical Technology 52

Medical Technology healthcare technology 52

Aging in Place Technology Watch

DECEMBER 19, 2018

In July, Tim Cook apparently did not want to get into the world of FDA regulation. In this new watch, both the ECG feature and fall detection have received FDA clearance within 30 days of applying, startling some observers who noted that closer to 150 days was more typical for a medical device.

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Aging in Place Technology Watch

JANUARY 17, 2019

It’s an analog watch that can also measure electrocardiograms, and it is currently pending FDA clearance." category tags: hearing loss , vehicle/transportation technology-services , digital health , fall prevention, fall detection. more at Withings. ZVOX VoiceBuds. VoiceBuds® use the latest digital technology to make speech more clear.

Digital Health 96

Digital Health 96

Aging in Place Technology Watch

JANUARY 8, 2022

Patient-monitoring startup Biobeat said today that the FDA has cleared its patch and watch for measurement of blood pressure, oxygenation and heart rate in hospitals, clinics, long-term care and at home. Eargo 6, its sixth-generation FDA Class II exempt hearing aid and most powerful device yet, was launched at CES 2022. Learn more.

Digital Health 75

Digital Health Telehealth 75

American Well

JUNE 4, 2018

Fortunately, there is already a standard of interoperability and cybersecurity from the FDA. With a software update and perhaps a few new peripherals, some with price tags as little as $10, your original machine can now work for everyone. A hypothetical: You have a group of patients with mostly the same needs.

Telehealth 48

Telehealth HIPAA Interoperability Telemedicine 48

American Well

JUNE 4, 2018

Fortunately, there is already a standard of interoperability and cybersecurity from the FDA. With a software update and perhaps a few new peripherals, some with price tags as little as $10, your original machine can now work for everyone. A hypothetical: You have a group of patients with mostly the same needs.

Telehealth 48

Telehealth HIPAA Interoperability Telemedicine 48

Aging in Place Technology Watch

MARCH 28, 2019

category tags: mHealth-Digital Health-Telehealth-Voice Health , hearing loss , wearables, smart watch , vehicle/transportation technology-services. In case a loved one is confused or lost, the caregiver can calm him down and help guide him to safety." Learn more at LocateMotion. KardiaBand. " The only EKG solution for Apple Watch® Series 1-3.

mHealth 111

mHealth Mobile Health Patient Experience Nursing 111

Aging in Place Technology Watch

JANUARY 17, 2019

It’s an analog watch that can also measure electrocardiograms, and it is currently pending FDA clearance." category tags: hearing loss , vehicle/transportation technology-services , digital health , fall prevention, fall detection. more at Withings. ZVOX VoiceBuds. VoiceBuds® use the latest digital technology to make speech more clear.

Digital Health 77

Digital Health 77

American Well

DECEMBER 19, 2017

Fortunately, there is already a standard of interoperability and cybersecurity from the FDA. With a software update and perhaps a few new peripherals, some with price tags as little as $10, your original machine can now work for everyone. A hypothetical: You have a group of patients with mostly the same needs.

Telehealth 48

Telehealth HIPAA Interoperability Telemedicine 48

American Well

DECEMBER 19, 2017

Fortunately, there is already a standard of interoperability and cybersecurity from the FDA. With a software update and perhaps a few new peripherals, some with price tags as little as $10, your original machine can now work for everyone. A hypothetical: You have a group of patients with mostly the same needs.

Telehealth 48

Telehealth HIPAA Interoperability Telemedicine 48

Healthcare IT News - Telehealth

JANUARY 22, 2021

For reimbursement by the CMS, a device must be an FDA-listed device. However, an FDA approval ensures a medical device is safe and effective for its intended use. FDA classifies medical devices into three classes based on risk to human life.

FHIR 175

FHIR EHR Telehealth EMR 175