STAT+: FDA proposes changes to key approval pathway for medical devices, five years after promising
Five years after promising to fix a flawed regulatory pathway widely used by medical device…
Category: medical devices
STAT+: As competition looms, Insulet sues a rival for allegedly stealing trade secrets on diabetes tech
Insulet filed a lawsuit this month against its rival EOFlow, accusing it of stealing trade…
FDA greenlights medical device to combat bladder issues
You’re reading the web edition of STAT Health Tech, our guide to how tech is…
STAT+: FDA advisory panel to debate contentious data on Medtronic’s high blood pressure device
An advisory committee to the Food and Drug Administration will convene on Tuesday to evaluate…
STAT+: Health care CEOs hauled in $4 billion last year as inflation pinched workers, analysis shows
The health care industry didn’t just provide a safe haven for jittery stock investors in…
The latest recall of Philips ventilators reveals one death, two injuries
In March, Philips recalled more than 73,000 ventilators that absorbed dust and dirt into breathing…
Opinion: Home blood pressure machines are often wrong. The FDA must speak up
Hypertension is considered to be the No. 1 risk factor for death globally. So it’s…
Kim Kardashian sparks debate on the benefits of full-body MRI scans
The last time Kim Kardashian posted about medical imaging, it was to prove her butt…
STAT+: For brain-computer interfaces, the commercial hurdles may be bigger than scientific ones
Rodney Gorham loves fast, flashy cars: His WhatsApp profile picture is a bright yellow Corvette…
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STAT+: Flow Neuroscience shows promising results in trial of brain-stimulation headset for depression
Flow Neuroscience, a small Swedish company treating depression with brain-stimulating headsets, released early data on…
To detect breast cancer sooner, an MIT professor designs an ultrasound bra
Canan Dagdeviren has dedicated her career to creating tools that can capture data from every…
STAT+: Medical device maker Teleflex to acquire urology company Palette Life Sciences for $600 million
Teleflex announced plans on Wednesday to acquire Palette Life Sciences, the maker of a slate…
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STAT+: Truvian presents data for its desktop blood-testing device in a field still in Theranos’s shadow
SAN DIEGO — Truvian Health, a San Diego blood diagnostics company, shared data on Tuesday…
STAT+: To get better heart data from wearables, researchers train AI to separate the signal from the noise
As wearable health devices grow more popular in the U.S., there’s a growing opportunity to…
STAT+: As digital health tech proliferates, a new institute aims to cut through hype
A new $50 million nonprofit initiative aims to independently evaluate health technologies’ impact on costs…
Hearing aids may slow mental decline in those at higher risk of dementia, study finds
Doctors have long suspected that hearing loss in older adults hastens dementia, the cognitive decline…
Nearly 8,000 blood tests recalled over risk of missed heart attack diagnosis
QuidelOrtho has recalled nearly 8,000 potentially faulty blood tests meant to help doctors quickly determine…
STAT+: Dexcom CEO on strategy for bringing continuous glucose monitoring to type 2 diabetes patients
For years, diabetes tech company Dexcom has been striving to get its continuous glucose monitors…
STAT+: Medicare’s new proposal to cover medical devices draws a mixed reaction
The medical device industry is split on whether a proposed new Medicare reimbursement pathway will…
STAT+: With Wegovy and Ozempic’s success, can device makers keep up in the race to treat obesity?
The makers of minimally invasive surgical devices seemed poised to capture a wide swath of…
Does DIY still have a place in diabetes care?
When Dana Lewis built her first artificial pancreas in 2014, she — and millions of…
CMS proposes new pathway for reimbursing breakthrough devices
Medical device makers may soon have an easier path to securing health insurance reimbursement for…
STAT+: Federal advisory group rejects proposal to make medical device tracking easier
Every medical device has its own unique code, allowing manufacturers to keep track of their…
FDA’s letter to medical device maker iRhythm is a warning for the industry
Heart monitoring company iRhythm is in hot water with the Food and Drug Administration, which…
For many who use power wheelchairs, CMS decision just made seat elevation much less expensive
This article is adapted from STAT’s latest report, Decoding Medicare: 10 key coverage decisions and…
Listen: Fake medical devices, real cancer drugs, & curious Ozempic effects
Why are fake medical devices more lucrative than real ones? Is Ozempic a neurological treatment?…
STAT+: Lured by a bigger payday, a medical device maker sold fake plastic parts. Many were implanted in chronic pain patients
Stimwave’s pitch was alluring. As a startup tackling chronic pain with nerve-stimulating devices, it promised…
STAT+: Neuralink can now study its brain implant in humans, but it’s still catching up to its peers
Neuralink can now study its brain implant in humans after securing a go-ahead from the…
Omada tackles obesity drugs, Boston Scientific nixes deal, and Microsoft health exec on GPT
You’re reading the web edition of STAT Health Tech, our guide to how tech is…
STAT+: Boston Scientific cancels $230 million deal to buy Korean device company
Boston Scientific is scrapping its $230 million plan to buy a majority stake in M.I….
STAT+: Masimo’s CEO on battling Apple for the health wearable market
It’s been a chaotic three years for Masimo CEO Joe Kiani. First came the pandemic,…
An ultrasound device may unlock brain cancer treatment, early study shows
Brain cancer patients are left with few options when tumor cells spread, as most potent…
STAT+: Legal battle between Apple and Masimo over trade secrets ends in mistrial
A California jury was unable to reach a verdict in a messy, drawn-out legal battle…
A research team airs the messy truth about AI in medicine — and gives hospitals a guide to fix it
In public, hospitals rave about artificial intelligence. They trumpet the technology in press releases, plaster…
Wireless pacemakers may work for children with slow heart rhythms — but first, doctors need child-sized catheters
Pacemakers, relied upon by many patients with irregular heart rhythms, are not built for children….
EPA proposes limits on carcinogenic gas used to sterilize medical devices
On Tuesday, the Environmental Protection Agency proposed new limits on the use of a carcinogenic…
FDA warns some Philips respirators may not deliver the right treatment
On Friday, the Food and Drug Administration issued a Class I recall for certain Philips…
Abbott recalls 4 million glucose monitor readers over risk they can catch fire
Health care giant Abbott has recalled four million readers for glucose monitors after reports that…
STAT+: With Apollo Endosurgery acquisition, Boston Scientific dives into the obesity treatment market
The landscape of obesity treatment is quickly changing — and with its acquisition this week…
STAT+: Former Magellan Diagnostics execs charged with selling defective lead testing machines used for kids
Three former executives at Magellan Diagnostics Inc. are charged with knowingly selling defective lead testing…
Apple and Masimo face off in trial over patient monitoring patents
You’re reading the web edition of STAT Health Tech, our guide to how tech is…
STAT+: Medical device companies now need to prove to FDA they’re protected against cyber attacks
Hidden in this year’s federal spending bill, among major changes to Medicare payments to doctors…
STAT+: A new Medicare ruling could give virtual reality companies an easier path to payment
The path to payment for virtual reality companies working in health care just became slightly…
STAT+: Momentum grows to subject medical devices to medicine’s gold standard — the placebo treatment
It’s the gold standard in medicine: taking a treatment, and putting it head-to-head against a…
These blood-clot catching devices have been controversial for years. Why are doctors still relying on them?
Inferior vena cava filters are supposed to save lives. The spider-like devices catch blood clots…
An FDA pathway to clear medical devices is putting patients at risk, research suggests
The Food and Drug Administration’s approach to evaluating some new medical devices might actually increase…
STAT+: The FDA’s ‘breakthrough’ program for medical devices keeps gaining steam
For medical devices in the Breakthrough Devices Program, 2022 has been a breakout year. The…
STAT+: Apple Watch hit with import ban, but ruling remains suspended as AliveCor patent battle plays out
In the latest twist in a battle between Apple and medical device company AliveCor, the…
No one’s quite sure how to fix pulse oximeters. The FDA asked this lab to find answers
SAN FRANCISCO — The discovery that fingertip oxygen-measuring devices might contribute to health disparities because…
Opinion: To protect the medical supply chain, ‘made in America’ will be key
The Covid-19 pandemic exposed a serious flaw in the United States’ medical supply chain: an…