LITTLE ROCK, Ark. (AP) — Building a successful medical device startup is more expensive and time-consuming than building other types of small businesses, but the potential return on investment is...
WASHINGTON (AP) — Joe Biden was on friendly turf when he appeared in January 2018 at a San Francisco health care conference to call for urgency in the search for a cancer cure. He had come before...
KALAMAZOO, Mich. (AP) — Health officials say some Michigan patients who had a test used to help evaluate for constipation or incontinence should consider being tested for HIV and...
KNOXVILLE, Tenn. (AP) — In an exam room at East Tennessee Children's Hospital, all eyes were on 14-year-old Tinsley Allen as he became the first patient in Tennessee and one of the first in the...
Maine, NH piece of medical device settlement each $1.4M
AUGUSTA, Maine (AP) — Both Maine and New Hampshire will receive $1.4 million each as their share of a multistate settlement with medical device companies.
They and 43 other attorneys general, including Vermont's, reached the $120 million consent judgment with Medical Device Business Services and other defendants to resolve allegations the company unlawfully promoted a pair of hip implant devices.
FDA permits ‘export only’ medical devices not for use in US
Australian Army veteran Wolfgang Neszpor was stunned when he heard his recently repaired shoulder squeak.
"You could really hear it," he said.
He recalled when the surgeon examined him and lifted up his arm, "It was a stupid amount of pain." Two months earlier, Neszpor, 36, had gotten a new shoulder joint, a PyroTITAN made by Integra LifeSciences of New Jersey.
Insulin pumps have most reported problems in FDA database
DESTIN, Florida (AP) — When Polly Varnado's 9-year-old daughter was diagnosed with Type 1 diabetes, it didn't take long for the family to hear about insulin pumps.
In September 2012, the girl picked out a purple one — her favorite color.
Over the next seven months, she proceeded to be hospitalized four times in a McComb, Mississippi medical center with high blood sugar. But when Varnado asked about all her daughter's problems, she said, her doctor blamed user error.
FDA’s ‘flawed’ device pathway persists with industry backing
WASHINGTON (AP) — Roughly 3,000 medical devices enter the U.S. market every year through a system that generally requires little or no patient testing to verify safety and effectiveness.
Unlike new pharmaceuticals, most medical devices reviewed by the Food and Drug Administration are cleared based on similarities to already-approved devices, not specific clinical trial testing.
Improving medical device tracking a slow, imperfect process
WASHINGTON (AP) — For nearly two decades, health advocates have pushed to standardize the way medical devices are tracked and studied.
They eventually landed on a solution that others, including other parts of the medical industry, already had adopted — a unique code to help track the type, manufacturer and other key information about a device.
In 2007, Congress asked the U.S. Food and Drug Administration to create the system, and the FDA passed a final rule establishing it in 2013.
Spinal device to treat pain shocks, burns patients
Spinal device to treat pain causes shocks, burns
Patients shocked, burned by device touted to treat pain
COLUMBIA, South Carolina (AP) — Desperate for relief after years of agony, Jim Taft listened intently as his pain management doctor described a medical device that could change his life.
It wouldn't fix the nerve damage in his mangled right arm, Taft and his wife recalled the doctor saying, but a spinal-cord stimulator would cloak his pain, making him "good as new."
Medtronic co-founder who created wearable pacemaker dies
MINNEAPOLIS (AP) — Earl Bakken, an electronics repairman who created the first wearable external pacemaker and co-founded one of the world's largest medical device companies, Medtronic, has died. He was 94.
Bakken, who also commercialized the first implantable pacemaker in 1960, died Sunday at his home in Hawaii, Medtronic said in a statement. It didn't give a cause of death.
The Apple Watch is inching toward becoming a medical device
CUPERTINO, Calif. (AP) — Apple is trying to turn its smartwatch from a niche gadget into a lifeline to better health by slowly evolving it into a medical device.
In its fourth incarnation, called Series 4 and due out later this month, the Apple Watch will add features that allow it to take high-quality heart readings and detect falls. It's part of Apple's long-in-the-making strategy to give people a distinct reason to buy a wrist gadget that largely does things smartphones already do.
Medical device maker settles suit over psychologist’s death
HARTFORD, Conn. (AP) — A medical device maker has settled a lawsuit over the death of a prominent Yale University psychologist who died in 2013 when a machine part detached and caused her blood to be pumped onto a hospital room floor.
WASHINGTON (AP) — The House has voted to repeal a tax on some medical devices that has helped finance President Barack Obama's health care overhaul.
Revoking the 2.3 percent tax has been a longtime goal for Republicans and some Democrats from states that are home to device manufacturers. Tuesday's vote was 283-132.
Repeal proponents say the levy kills jobs and hurts manufacturers. Opponents and some outside analysts say its impact is trifling.
MINNEAPOLIS (AP) — A medical device company in Minnesota will pay investors $43 million in a proposed class-action legal settlement that would resolve one of the last remaining lawsuits involving its bone-growth product.
COLONIE, N.Y. (AP) — A New York-based medical device company will pay the U.S. government $12.5 million to resolve allegations that it had health care providers submit false claims to federal programs.
The Department of Justice said Wednesday that suburban Albany-based AngioDynamics will pay $11.5 million to resolve allegations related to an unapproved drug delivery device. The company will also pay another $1 million to settle claims stemming from a device used to treat malfunctioning veins.
BEIJING (AP) — Chinese exporters were scrambling Monday to cope with a plunge in U.S. sales while China's state press shrugged off the impact of Washington's tariff hikes in a spiraling technology dispute.
WOLCOTT, Conn. (AP) — Seventy-four years after inventor Frank DeBisschop opened a tool and die shop in Thomaston, his grandson is still running a spinoff of his manufacturing business, mass-producing medical devices and honing prototypes in Wolcott.
Experts gather in Twin Cities to discuss protecting medical targets from hackers
When computer hackers breach a hospital system, they work quickly to find valuable patient medical records to smuggle out, while also infecting other computers that might harbor valuable data or protect their unauthorized network access.
Dear Doctor: As a fan of the TV show "Homeland," I was skeptical (and also creeped out) when a character was assassinated by someone hacking his pacemaker. But I just read that this might actually be possible. My dad has a pacemaker, and now I'm worried. Is this really a serious risk?
WASHINGTON (AP) — U.S. health officials on Tuesday proposed steps to improve the government's system for overseeing medical devices, which has been criticized for years for failing to catch problems with risky implants and medical instruments.
The plan from the Food and Drug Administration includes few immediate changes, but lists a number of ideas and proposals with the goal of improving safeguards on pacemakers, artificial joints, medical scanners and other devices.
Medical devices can extend and save lives but only if someone will pay for them.
Appeals court panel revives suit faulting Medtronic drug pump in patient death
The Minnesota Court of Appeals is reviving a lawsuit against Medtronic from the mother of a deceased patient, despite the medical device makers insistence in court filings that it is all but immune from personal liability in such cases.
Young entrepreneurs to make pitches for $50K in prizes during Morgenthaler-Pavey competition
Young entrepreneurs to make pitches for $50K in prizes during Morgenthaler-Pavey competition
CLEVELAND, Ohio - Six startups will compete for $50,000 in prizes Thursday as part of a program at Case Western Reserve University that honors legendary investor David Morgenthaler.
Busy heart hospitals and clinics often have a procedure room where pacemaker and defibrillator patients go to get regular checkups on the small computers implanted inside their chests.
Lately, device companies have been reminding doctors to make sure to lock the doors and cabinets in those rooms, as reports surface that the machines used to conduct the device checkups could be vulnerable targets for hackers and thieves.
U.S. regulators have approved a tiny mechanical valve for young children with troubled hearts, culminating years of effort in Minnesota to produce a dependable pediatric version of a common adult-sized medical device.
The Food and Drug Administration announced Tuesday that it has granted approval for Illinois-based Abbott Laboratories to sell the 15-millimeter Masters Series Mechanical Heart Valve with Hemodynamic Plus, making it the smallest mechanical valve available commercially in the world.
Medtronic gets OK to sell glucose monitor, small stent
Medical device maker Medtronic announced two regulatory approvals on Monday, including a new way that patients with diabetes can use its latest blood-glucose monitor and a narrower stent that fits inside some of the smallest blood vessels near the heart.
Woman pleads guilty in alleged bogus medical device scheme
SIOUX FALLS, S.D. (AP) — A Canadian woman has pleaded guilty in federal court in South Dakota in what authorities say was a scheme to sell bogus laser medical devices known as QLasers.
The Justice Department says 63-year-old Irina Kossovskaia of Ontario, Canada, reached a deal with prosecutors and pleaded guilty to a conspiracy charge Wednesday. She faces up to five years in prison. A sentencing date wasn't immediately set.
During the three years that the government collected a tax on sales of medical devices, Maple Grove’s Inspire Medical Systems never turned a profit on its sleep apnea treatments.
CEO Tim Herbert says the company could have had 12 to 15 more employees if that tax money, which helped pay for the Affordable Care Act, had stayed in-house.
Medical device tax is back; industry seeks repeal
WASHINGTON - Like a medical condition that won't go away, a controversial Affordable Care Act tax on medical device manufacturers was reinstated on Jan. 1 despite repeated drives to end it for good.
The 2.3 percent excise tax was placed on makers of devices like catheters and artificial joints with the goal of raising $29 billion over 10 years to cover some of the costs of providing Obamacare medical insurance to previously uninsured Americans.
BOSTON - While much of corporate America will enjoy a tax cut in the new year, one industry is getting a tax increase it has fought hard but so far unsuccessfully to avoid.
A 2.3 percent excise tax on medical device manufacturers went back into effect Monday after a two-year hiatus. It was first imposed in 2013 as one of several taxes and fees in the Affordable Care Act that pay for expanded health insurance under the law.
Tax on medical devices to resume after 2-year suspension
BOSTON (AP) — While much of corporate America will enjoy a tax cut in the new year, one industry is getting a tax increase it has fought hard but so far unsuccessfully to avoid.
A 2.3 percent excise tax on medical device manufacturers went back into effect Monday after a two-year hiatus. It was originally imposed in 2013 as one of several taxes and fees in the Affordable Care Act that pay for expanded health insurance under the law.
Medical Device Professional Living With Diabetes Now Uses The Insulin Pump He Helped Get Approved In The U.S.
(NAPSI)—Chip Zimliki, 47, had been living with type 1 diabetes for over 33 years and was managing his blood sugar levels with multiple daily injections (MDI). This meant Chip had to give himself a shot of long acting insulin once a day, as well as injections of rapid acting insulin at each mealtime. Having worked at the Food and Drug Administration (FDA) for eight years, Chip was very familiar with insulin pump therapy and the advancements made to increase automation and create what’s called “hybrid closed loop technology.”
Apple Inc. is developing an advanced heart-monitoring feature for future versions of its smartwatch, part of a broader push by the company to turn what was once a luxury fashion accessory into a serious medical device, according to people familiar with the plan.
By Matt Murphy
State House News Service
BOSTON -- The failure of Republicans in Congress this year to repeal the Affordable Care Act means that a controversial tax on medical-device sales will return in 2018 unless legislators intervene in the next couple weeks, putting a major Bay State industry on edge.
Rep. Erik Paulson co-sponsor of bill to suspend collecting medical device tax
WASHINGTON — Some members of the House Ways and Means Committee, including Minnesota Republican Rep. Erik Paulsen, want to suspend collection of a medical device tax for five more years.
WASHINGTON As the U.S. Senate and House resolve different plans to cut taxes for American corporations and businesses, the repeal of the medical device tax is missing from the discussion.
Killing the 2.3 percent tax on device sales, a top legislative priority for Minnesotas massive medical technology sector, did not make it into either the Senate or House versions of tax reform.
India is reopening discussions about its price caps on coronary stents next year, after protests from medical-device companies that want to pull their high-end stents off the Indian market because they say they are being forced to sell them at a loss.
Two U.S. senators are urging the agency that controls Medicare to support putting the full serial numbers for medical devices into insurance-claims forms to better track how poorly performing devices affect federal spending and patient health.
AdvaMed turns to White House to intervene in stent price cap dispute with India
The U.S. medical device lobby in Washington is asking the White Houses top trade official to strip away a coveted favorable-trade status for goods from India following Indian officials refusal to lift price caps on imported heart stents and knee implants.
Medical device supplier plans Fort Wayne expansion
FORT WAYNE, Ind. (AP) — A company that makes precision wire and cables for the medical device industry is planning a $51 million expansion of its Fort Wayne facilities.
Fort Wayne Metals said Wednesday its project would include an addition to its corporate office building and renovation of a factory building it recently bought. Both facilities are near Fort Wayne International Airport.