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12838 results for "fda-cleared devices"
A Baltimore medical company just received FDA clearance for a device that makes minimally invasive heart procedures safer and easier. The breakthrough tool completed its first human trials with 100% success and zero complications.
The FDA is speeding up approval for AI-powered medical devices through a breakthrough program designed to get innovative health tech to patients faster. A new pilot launching this year will accelerate early-stage clinical trials for promising AI tools.
A new app just became the first FDA-cleared medical device that lets diabetes patients chat with AI to manage their treatment. UpDoc's breakthrough technology translates doctor plans into daily guidance through simple voice and text conversations.
A tech journalist regrew visible hair in just eight weeks using a light therapy cap after shaving his head for 15 years. The science-backed device uses specific red-light wavelengths to wake up dormant follicles.
Federal agencies just launched a new pathway to get breakthrough medical devices covered by Medicare faster. The program could help millions of seniors access life-changing technology sooner.
A new once-daily pill just won FDA approval after helping 7 out of 10 people with moderate to severe psoriasis achieve clear or nearly clear skin in clinical trials. The treatment offers hope to more than 8 million Americans living with the painful skin condition.
A headset that uses gentle electrical pulses to treat depression just won FDA approval for home use. The device offers a medication-free option for millions struggling with mental health.
For the first time, children 2 and older can get continuous glucose monitors without a prescription, potentially helping families catch diabetes risk early. The FDA's decision opens new doors for underserved kids who couldn't afford prescription devices.
For the first time in three decades, patients with inoperable pancreatic cancer have a new treatment option. The FDA just approved Optune Pax, a wearable device you use at home that uses electric fields to kill cancer cells.
Patients with one of the deadliest cancers can now use an electric field device at home alongside chemotherapy. The wearable patches add two months of survival time without the harsh side effects of traditional treatments.
For the first time, Americans with depression can use a prescription brain-stimulation device at home, marking a breakthrough for the 7 million people who don't respond to traditional medication. The FDA-approved headset delivers gentle electrical currents to restore healthier brain activity in just 30 minutes a day.
Life-saving medical devices will reach patients up to 10 months faster thanks to a groundbreaking partnership between the FDA and Medicare. The new RAPID program could help 60 devices get immediate coverage approval.
A groundbreaking treatment that could prevent PTSD before it takes hold just cleared a major regulatory hurdle. The FDA has approved human trials for RST-101, a drug designed to stop trauma from becoming chronic psychological distress.
A medical device designed to help cancer patients has passed its final safety review with zero serious side effects, clearing the way for the last phase of testing. The clean safety record brings hope for future cancer treatment options.
Wearable fitness tracker Whoop resolved a year-long dispute with federal regulators, opening the door for more personal health data to reach consumers. The FDA ended enforcement action after the company tweaked how its blood pressure feature works. #
Surgeons can now track spinal movement in real time during surgery thanks to a newly cleared robotic system that combines planning, navigation, and execution in one platform. The technology aims to make complex spine procedures more precise and predictable for millions of patients.
A tongue-stimulating mouthpiece just got FDA approval to treat the phantom ringing that affects 25 million Americans. Clinical trials show 91% of users experienced major relief from their tinnitus symptoms.
After three decades without new options, patients with locally advanced pancreatic cancer now have access to a wearable device that extends life and reduces pain. The breakthrough treatment adds two months of survival time while maintaining quality of life.
Nearly 10 million Americans under 60 with hearing loss can now access affordable solutions starting at just $100, thanks to a 2022 FDA rule change that eliminated the prescription requirement. After testing 45 models over four years, experts confirm budget options now rival $4,000 prescription devices for mild to moderate hearing loss.
A simple earpiece could prevent devastating brain damage after hemorrhagic strokes by calming dangerous inflammation. The FDA just gave it breakthrough status to speed it to patients who desperately need it.
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