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FDA approves the first over-the-counter continuous glucose monitor
The US Food and Drug Administration has approved the first continuous glucose monitor (CGM) people can buy without a prescription.
Don't use smartwatches and rings that claim to measure blood sugar without needles, the FDA warns
“The FDA has not authorized, cleared, or approved any smartwatch or smart ring that is intended to measure or estimate blood glucose values on its own,” the agency wrote in a safety communication, and asked consumers, patients, and caregivers to stay away from such devices.
Samsung gets FDA approval for a sleep apnea feature on Galaxy Watch
The Food and Drug Administration has given Samsung approval to add a sleep apnea detection feature to Galaxy watch in the US,
Vibrating belt that treats low bone density gets FDA approval
The FDA has provided clearance for a medical device called Osteoboost, a vibrating belt that improves bone density in patients with osteopenia.
2023 was a big year for CRISPR-based gene editing but challenges remain
2023 was an important year for patients with sickle cell disease. The FDA approved Vertex’s “Casgevy,” a CRISPR-based therapy for the treatment of sickle cell disease marking it as the first genetically edited therapy to reach the general market.
CRISPR-based gene editing therapy approved by the FDA for the first time
The FDA greenlit two new drugs for the treatment of sickle cell disease in patients 12 and older, one of which —Vertex’s drug Casgevy.
UK authorizes first gene therapy for treating sickle cell disease
The UK’s Medicines and Healthcare products Agency approved the first-ever CRISPR-based gene editing treatment for blood disorders.
Researchers developed a gene-editing technology that reduces 'bad' cholesterol
Researchers discovered that a single infusion of a gene-editing treatment called VERVE-101 can reduce high cholesterol in patients.
The new COVID-19 vaccines are here for the fall
A new lineup of COVID-19 vaccines are now available in the US. The CDC is urging most Americans to get an updated COVID-19 vaccine.
The most common oral decongestant in the US does not work, FDA finds
The FDA ruled that phenylephrine, a key ingredient in many over-the-counter cold medications, does not actually work to treat nasal congestion when taken orally. The agency will now need to determine if it will revoke the ingredient's oral OTC designation as “safe and effective.”
Withings gets FDA approval for its upcoming Body Scan Connected Health Station
The Withings Body Scan Connected Health Station has received the go-ahead from the FDA and is set to launch this fall. Engadget’s Daniel Cooper tried it earlier this year and had “nothing but praise for” the luxury smart scale when trying it earlier this year, although he also described its $400 price tag as “mad money” to pay for an extravagance many of us won’t need.
FDA approves first oral postpartum depression pill
The FDA approves a new pill for postpartum depression. The drug was developed by Biogen and Sage.The approval is based on research that backs the oral drug's effectiveness.
Johnson & Johnson gets FDA approval for heart treatments that don't require X-rays
Johnson and Johnson MedTech got FDA approval for a safer heart treatment workflow that reduces the risk of cancer for patients and providers. The approval is the first and only of its kind.
The first drug that slows Alzheimer's has finally received FDA approval
Japanese drugmaker Eisai and US-based Biogen have received FDA approval for Leqembi, making it the first approved treatment available that can slow the progression of Alzheimer’s in patients.
FDA approves Owlet’s baby-monitoring sock two years after halting sales
Owlet, a baby monitoring device manufacturer, has received a nod from the FDA for its latest pulse-oximeter device BabySat. The approval comes after the FDA previously took the technology off consumer shelves.
Neuralink receives FDA clearance to begin human trials of its brain-computer interface (Updated)
Following a reported denial in March, the FDA approved Neuralink's application to begin human trials of its prototype Link brain-computer interface (BCI) on Thursday.
FDA reportedly denied Neuralink's request to begin human trials of its brain implant
According to Reuters, the FDA denied Neuralink's request to being human trials last year over concerns of safety arising from animal model testing.
FDA clears Wandercraft's exoskeleton for stroke patient rehab
Wandercraft's exoskeleton has received FDA clearance to help stroke patients recover their gait.
Over-the-counter hearing aids go on sale in the US
A prescription is no longer needed for those with mild-to-moderate hearing impairment, the FDA said.
The FDA may have unintentionally made 'NyQuil Chicken' go viral on TikTok
Nyquil Chicken was neither new, nor particularly viral, and the FDA’s bizarrely-timed warning may have backfired, making the meme more popular than ever.
