STAT+: Most cardiovascular devices with serious safety recalls aren’t tested in patients
When someone’s heart doesn’t beat quite right, an implantable defibrillator can save their life. The…
Category: medical devices
STAT+: A ‘tie-breaker’ study of Abbott’s heart clip brings more questions than answers
A study meant to serve as a tie-breaker between two major trials of a heart…
Opinion: Medicare’s new transitional coverage of emerging technologies program doesn’t go far enough
Included in the original law that established Medicare in 1965 was a short but consequential…
Glucose monitors, mpox vaccine inequity and effects of LGBTQ+ restrictions
STAT’s coverage of chronic health issues is supported by a grant from Bloomberg Philanthropies. Our financial…
STAT+: Continuous glucose monitoring for the masses is here. Are we ready for it?
NEW YORK — Glucose tracking is the future, Dexcom executives gushed at a glitzy launch…
STAT+: Q&A: How the FDA could use AI for drug and device safety surveillance
The Food and Drug Administration’s responsibilities don’t end when a drug hits the market after…
STAT+: Another suit filed against FDA over lab-developed test rule
A group representing molecular pathologists sued the Food and Drug Administration on Monday over its…
STAT+: AI app claiming to diagnose STIs from penis pictures shut down after FTC scrutiny
The company that claimed its AI model could identify sexually transmitted infections from a single…
STAT+: Medicare finalizes reimbursement rule for breakthrough medical devices
The Centers for Medicare and Medicaid Services has finalized its rule easing reimbursement for medical…
STAT+: Jeff Shuren stabilized the FDA’s medical devices center, winning over industry but not all patients
Retirements from the Food and Drug Administration are hardly shocking, especially in the wake of…
Robotic aid helped improve balance, gait in children with cerebral palsy
For many kids with cerebral palsy, walking is taxing. They might spend thousands of hours…
Opinion: Fixing the reimbursement and coverage divide between ‘breakthrough’ drugs and medical devices
The Food and Drug Administration designates as “breakthrough” technologies certain drugs and devices. This designation…
House panel passes bills to expand Medicare obesity drug coverage, cancer screening
WASHINGTON — A House committee overwhelmingly passed four bills on Thursday that would expand Medicare…
STAT+: Experts split on whether Eli Lilly’s Zepbound will hamper CPAP sales
Continuous positive airway pressure “is here to stay,” sleep medicine doctor Atul Malhotra declared in…
STAT+: How the medical device tracking director at Kaiser Permanente weeds out risky devices
When a new medical device hits the market, there’s typically still some uncertainty about whether…
STAT+: Boston Scientific to buy vascular device maker for $1.16 billion
Boston Scientific said on Tuesday it will buy Silk Road Medical, a medical device company…
STAT+: Former medical device CEO who sold fake plastic parts sentenced to 6 years in prison
The former CEO of Stimwave, a company that sold pain-relief devices with dummy pieces of…
STAT+: Medical device trials still don’t enroll enough women, study finds
Women have always been underrepresented in medical research. A new study reveals that not much…
STAT+: How a device maker inundated pain patients with unwanted batteries and surprise bills
Michelle Bean is drowning in batteries she doesn’t need. For two years, the batteries and…
5 takeaways from STAT’s look at unwanted supplies and surprise bills from device maker Zynex Medical
Sending patients heaps of medical supplies to score more money from insurers is common in…
STAT+: Becton Dickinson to buy Edwards patient monitoring unit for $4.2 billion
Becton Dickinson plans to pay $4.2 billion for Edwards Lifesciences’ critical care business, which sells…
STAT+: Clinical lab trade group sues FDA over plan to regulate lab-developed tests
A group representing clinical labs across the country sued the Food and Drug Administration on…
To detect risk of stroke, tiny probe acts ‘like a microscope’ inside brain’s blood vessels
To better understand problems in the brain’s blood vessels that may lead to stroke, we…
STAT+: Abbott’s dissolvable stent, which failed in heart disease patients, may help vascular patients
An Abbott device that failed in heart disease patients is getting a new life in…
STAT+: The White House hikes tariffs on Chinese medical products
WASHINGTON — The Biden administration announced Tuesday that it’s raising taxes on a range of…
Opinion: Health care needs a new profession: neuroimaging counseling
Until recently, getting an MRI meant traveling to the hospital. But a new generation of…
STAT+: Software glitch caused Tandem insulin pumps to prematurely shut down, FDA warns
At least 224 diabetes patients have been harmed by a software error causing their insulin…
STAT+: Akili to lay off 46% of its staff, explore strategic options amid sluggish sales
Akili Interactive on Tuesday announced it will lay off 46% of its staff and evaluate…
STAT+: FDA finalizes plan to regulate some lab-developed tests
The Food and Drug Administration will start actively regulating tests developed in laboratories, with some…
Philips will pay $1.1 billion to resolve U.S. lawsuits over breathing machines that expel debris
WASHINGTON — Medical device maker Philips said Monday it will pay $1.1 billion to settle…
STAT+: Medicare official says breakthrough device reimbursement rule coming in early summer
WASHINGTON — A federal rule aiming to make reimbursement for breakthrough devices easier is slated…
STAT+: The next frontier in data privacy? Your brain
Consumer neurotechnology is booming. You can buy a funky-looking headband for $500 on the internet…
Philips, maker of millions of defective sleep apnea machines, ordered to overhaul manufacturing
WASHINGTON — The company responsible for a global recall of sleep apnea machines will be barred…
STAT+: Device made by company J&J is buying for $13 billion clears hurdle in independent study
A fully independent clinical trial researchers thought might disprove a cardiac device made by Shockwave…
STAT+: In first big randomized trial, Abiomed’s heart pump reduced deaths in heart attack patients
A controversial heart pump from Abiomed reduced the number of deaths in severe heart attack…
STAT+: Johnson & Johnson to buy Shockwave Medical for $13.1 billion
Johnson & Johnson on Friday announced it would acquire heart device firm Shockwave Medical for…
STAT+: FDA approves TriClip for tricuspid heart valve disease, pitting Abbott against Edwards
The Food and Drug Administration approved a new device from Abbott meant to treat tricuspid…
STAT+: FDA clears digital stethoscope company’s AI algorithm for heart failure
An AI algorithm to detect heart failure, embedded in a digital stethoscope, earned clearance from…
STAT+: This AI company scans penis pictures for STIs. Its unproven tech is in an FDA gray zone
Artificial intelligence is already assessing decay in your teeth, abnormalities in your heart rhythm, and…
STAT+: Payments by drug and device makers to doctors remain widespread, but also vary considerably
The financial ties between drug and device makers and some physicians remains pervasive, despite concerns…
Opinion: STAT+: Medical devices makers are trying to take a page from Uber’s playbook
In a recent survey of U.S. companies, medical device makers reported spending $31 million on…
STAT+: Digital tools for diabetes management did not deliver benefits that justify cost, new report finds
The last decade has seen billions of dollars flow into digital health companies that promise…
STAT+: EPA restricts cancer-causing chemical used to sterilize medical devices
On Thursday, the Environmental Protection Agency finalized limits on a carcinogenic gas called ethylene oxide…
STAT+: Researchers create talking throat patch for people with voice disorders
Researchers at the University of California, Los Angeles have built a soft, adhesive patch capable…
STAT+: U.K. researchers warn about biases in medical devices, health care algorithms
LONDON — Regulators, clinicians, and health care algorithm developers need to take additional steps to…
STAT+: Former medical device CEO who sold dummy, plastic parts convicted of fraud
A New York jury on Wednesday convicted the former CEO of Stimwave, a company that…
STAT+: FDA clears first over-the-counter continuous glucose monitor
For the first time, anyone in the United States will soon be able to buy…
STAT+: Medical device lobby says it’s tired of waiting on Medicare to cover breakthrough devices
Medical technology lobby AdvaMed is fed up with the Centers for Medicare and Medicaid Services….
STAT+: FDA warns medical device makers about rise in fabricated data
An increasing number of medical device companies are submitting fabricated and unreliable data, the Food…
Opinion: STAT readers on what human health care can learn from veterinary medicine and more
STAT now publishes selected Letters to the Editor received in response to First Opinion essays…