Top related persons:
Top related locs:
Top related orgs:

Search resuls for: "Medical Devices"


25 mentions found


Dr. Chatbot will see you now
  + stars: | 2023-06-06 | by ( Adam Rogers | ) www.businessinsider.com   time to read: +12 min
Almost invariably, the chatbot answers were rated as three or four times as reliable as the ones from the poor wee humans. But here's the most striking part: The chatbot answers, on average, were rated seven times as empathetic as the ones from humans. It's as if the unfeeling android Mr. Data figured out how to convincingly emulate Dr. Crusher's comforting bedside manner. Give those medical chatbots access to people's individual medical records, and they could offer more precisely directed advice. Healthcare AI startups will want the cheapest versions with the most financial bang, which won't necessarily have the best patient outcomes.
Persons: feely, San Diego lurked, I'm, ChatGPT, John Ayers, Ayers, , chatbot, they're, That's, They're, Teva Brender, Brender, Jonathan Chen, Greg Corrado, isn't, Adam Rogers Organizations: University of California, UC San Diego, Pew Research Center, Harvard, Google, Stanford University School of Medicine, Food and Drug Administration, Healthcare Locations: San Diego, San Francisco
Leqembi received accelerated approval from the FDA in January, based on limited evidence suggesting it would slow cognitive decline in early Alzheimer's patients. A panel of FDA advisers will discuss whether Leqembi should receive traditional approval next week, and a decision could come by early July. Medicare, the government health plan for Americans 65 and over, currently pays for Leqembi only if patients are enrolled in a clinical trial. Such "coverage with evidence development" requirements are rare and historically used by Medicare to evaluate medical devices rather than drugs. To receive Medicare coverage, people will need to be diagnosed with mild cognitive impairment or early dementia caused by Alzheimer's and have a qualified physician participating in a registry.
Persons: Biogen, Leqembi, Eisai, Eli Lilly, Co's, Eli Lilly's, Alzheimer's, Sue Peschin, Manas Mishra, Leroy D'souza, Bill Berkrot Organizations: U.S, Eisai Co, FDA, Medicare, Centers, Medicaid Services, CMS, Alzheimer’s Association, Alliance for Aging Research, Thomson Locations: Bengaluru
The two partners sought at their Trade and Technology Council in Sweden to find common interests, such as over artificial intelligence and future trade in environmentally-friendly goods, but China proved a pervasive topic. The statement said the EU and the United States were deeply concerned about foreign information manipulation, interference and disinformation. The European Union plans to recalibrate its China policy, recognising coordination with a more hawkish United States is essential. U.S. Secretary of State Antony Blinken said the EU's and the United States' views of China had increasingly converged, noting neither was looking for confrontation. They also said they were committed to working with the G7 to coordinate action to counteract acts of economic coercion, which would include trade restrictions the EU says China has imposed on EU member Lithuania.
Persons: Antony Blinken, Margrethe Vestager, Jonas Ekstromer, you've, Philip Blenkinsop, Emelia Sithole Organizations: European, Trade, Technology Council, TT News Agency, REUTERS, European Union, TTC, EU, Lithuania, Thomson Locations: Lulea, Sweden, REUTERS LULEA, United States, Ukraine, China, EU, Brussels, recalibrate, Africa, Latin America
Companies Koninklijke Philips NV FollowAMSTERDAM, May 16 (Reuters) - Dutch medical devices maker Philips (PHG.AS) said on Tuesday that independent tests had shown 95% of its respiratory devices involved in a major global recall had shown limited health risks. The company expects to have test results for the remaining machines involved in the recall later in the year. It said exposure to particulate matter emissions and volatile organic compounds from degraded foam in DreamStation devices was "unlikely to result in an appreciable harm to health in patients". Philips had already said last year that tests indicated foam degradation was very rare and was linked to the use of unauthorised ozone-based cleaning products. It now added that foam degradation as a result of such cleaning was also unlikely to result in an appreciable harm.
EU and US to pledge joint action over China
  + stars: | 2023-05-13 | by ( Philip Blenkinsop | ) www.reuters.com   time to read: +2 min
BRUSSELS, May 13 (Reuters) - Washington and the EU will pledge joint action to tackle concerns focused on China about non-market practices and coordinate their export controls on semiconductors and other goods at a meeting this month, a draft statement showed. Brussels says it considers China a partner in some fields, an economic competitor and a strategic rival. The European Union plans to recalibrate its China policy, recognising coordination with a more hawkish United States is essential. Highlighting the medical devices sector in China, the document said the transatlantic partners are "exploring possible actions" over the threat posed by non-market policies and practices. The two sides also said they were committed to working with the G7 to coordinate action to counteract acts of economic coercion, such as the trade restrictions the EU says China has imposed on EU member Lithuania.
Morgan Stanley reiterates Apple as overweight Morgan Stanley said Apple is "delivering under pressure" after its earnings report on Thursday. Guggenheim upgrades Portillo's to buy from neutral Guggenheim said it sees multiple expansion for the restaurant chain. Goldman Sachs downgrades Atlassian to neutral from buy Goldman said the company's "cloud transition [is] likely taking longer than expected." UBS upgrades Shopify to neutral from sell UBS said in its upgrade of Shopify that it sees revenue upside. Jefferies initiates Playboy Group as buy Jefferies said it sees "significant upside" for the adult themed global media and lifestyle company.
The membership of the panel at Musk’s company, Neuralink, raises questions about potential violations of conflict-of-interest regulations aimed at protecting research integrity, a dozen animal-research and bioethics experts told Reuters. Autumn Sorrells has chaired an oversight board approving animal experiments by Elon Musk’s brain-chip startup, Neuralink, and also run the company’s animal care program. Reuters couldn’t determine the compensation terms of the Neuralink IACUC members who are also company employees. The independence of such boards, Nicolelis said, is critical to protecting the integrity of animal research that could impact humans in future clinical trials. These institutions generally prohibit people with direct financial interests from serving on IACUCs or voting on animal experiments.
It may explore a private sale alongside a stock market listing, they added. An IPO might not take place until next year, as market conditions remain challenging for new listings, one person said. LimaCorporate, which designs orthopedic implants, posted revenue of 248.6 million euros ($274.5 million) for 2022, and adjusted earnings before interest, tax, depreciation and amortisation (EBITDA) of 66.2 million euros. It also reported a yearly loss of 27.9 million euros after taxes. EQT was reported in 2020 to be working with advisers on a possible IPO or sale of the business, but a transaction never materialised.
Abuja, Nigeria CNN —Nigeria’s food and drug regulator says it is investigating the popular Indomie brand of instant noodles following recalls in Malaysia and Taiwan where health authorities say they detected a potentially cancer-causing substance. “The public is … informed that the implicated Indomie instant noodle is not registered for sale in Nigeria. Indomie: The instant noodle giant in Nigeria 01:18 - Source: CNNIndonesian food giant Indofoods has defended the safety of its products. Indonesian food giant Indofoods says Indomie noodles is available in more than 100 countries across the world in Africa, Asia, Europe and the Middle East. Indomie first launched instant noodles in 1972 with a chicken flavor but is now produced in many varieties.
May 2 (Reuters) - DuPont de Nemours Inc (DD.N) on Tuesday cut its full-year revenue forecast, citing slower-than-expected recovery in the electronics and industrial markets, sending its shares down nearly 5% in premarket trading. The materials and chemicals maker expects customer utilization in the electronics markets to bottom in the "near-term" and improve only in the third quarter. DuPont cut the top-end of its annual sales forecast to $12.50 billion from $12.90 billion, while retaining the lower end at $12.30 billion. "Within electronics markets, we continue to see weakness and channel inventory destocking in the near-term," Chief Financial Officer Lori Koch said in a statement. "We continue to expect ongoing strength throughout the year in areas such as water, automotive, aerospace and healthcare," Koch said.
Investors may get one share in the spun-out entity for every share of the parent company they owned. What's left of J & J will be focused on pharmaceuticals and medical technologies, which were responsible for over 84% of the company's total 2022 revenue of $94.94 billion. It underscores that once free of the parent company tethers a divested company can chart its own destiny. Those priorities may not have necessarily been wrong when considering J & J as the overall enterprise. We believe J & J and Danaher are poised to deliver two more examples.
“We would like to emphasize that … our Indomie instant noodles are safe for consumption,” Taufik Wiraatmadja, a member of the board of directors at Indofoods, said in a statement issued Friday. Health officials in Malaysia and Taiwan said this week they had detected a compound called ethylene oxide in Indomie’s “special chicken” flavor noodles. Ethylene oxide is a colorless, odorless gas that is used to sterilize medical devices and spices. Indomie first launched instant noodles in 1972 with a chicken flavor. Unlike most types of instant ramen, Indomie noodles are typically eaten dry, without needing to prepare soup.
Circuit Court of Appeals, called the April 7 order by U.S. District Judge Matthew Kacsmaryk "abrupt and profoundly disruptive." The 5th Circuit is preparing to hear May 17 arguments on the matter after the U.S. Supreme Court last week put on hold Kacsmaryk's order. Danco Laboratories, which manufactures the brand-name version of the drug, was due to make a separate filing with the 5th Circuit. A panel of three 5th Circuit judges is scheduled to hear arguments on whether to uphold Kacsmaryk's order. The 5th Circuit has a conservative reputation, with 12 of its 16 active judges appointed by Republican presidents.
There is no evidence that tools used for cervical cancer screenings are cancerous, despite a video circulating online warning about the sterilisation process of test utensils. A controlled amount of the gas ethylene oxide (EO), a carcinogen, is used to sterilise medical instruments, but the process is safe, experts told Reuters. There is no evidence, however, that its use in cervical screening sterilisation processes is cancerous. Guidance from the World Health Organization (WHO) shows EO is used in the sterilisation process for speculums in line with international standards (here). The use of ethylene oxide in the sterilisation process for cervical cancer screening utensils is safe and strictly regulated.
The Supreme Court, which has a 6-3 conservative majority, is expected to act before the deadline to either grant or reject the requests or further pause the litigation. The Food and Drug Administration (FDA), the U.S. agency that signs off on the safety of food products, drugs and medical devices, approved mifepristone in 2000. Circuit Court of Appeals on April 12 declined to block the curbs ordered by Kacsmaryk. Anti-abortion groups led by the recently formed Alliance for Hippocratic Medicine and four anti-abortion doctors sued the FDA in November. The plaintiffs contend that the agency used an unlawful process to approve the drug, which they consider to be dangerous.
CNBC Pro used FactSet data to scan the stock market to find the biggest winners of the week — and then looked to find out where Wall Street thinks these stocks are headed in coming months. One name that stuck out on the list was once-troubled regional bank PacWest Bancorp , which jumped almost 12% this week as of Friday morning. Wall Street believes shares have 55% upside, according to the consensus 12-month price target set by analysts. PacWest shares had a strong week after regional banking peer Western Alliance Bancorp posted quarterly adjusted earnings, according to FactSet. BJ's Restaurants ' stock rose 9.2% this week after Wedbush Securities upgraded shares to outperform from neutral.
Lilly has not previously discussed its Medicare coverage optimism publicly. The U.S. Centers for Medicare & Medicaid Services (CMS) did not immediately respond to a request for comment. Such "coverage with evidence development" requirements are rare and historically used by Medicare to evaluate medical devices. Amyvid, Lilly's Alzheimer's imaging agent that can detect amyloid plaques on PET scans, has been subject to CMS' evidence development program for a decade. "It shuts out many patients," said Dr. Maria Carrillo, chief science officer of the Alzheimer’s Association, "especially minorities and rural patients."
Abbott is the second major company to signal a recovery in medical device sales. Medical devices - Abbott's largest segment - clocked an 8.5% rise in sales to $3.90 billion, with $1.2 billion coming from glucose monitoring device Freestyle Libre. I don't think it's a bolus of backlog," Abbott CEO Robert Ford said about the recovery in medical device sales. The stronger outlook for its non-COVID business was the main takeaway as investors had priced in a fall in COVID testing sales, J.P. Morgan analyst Robbie Marcus said in a note. Abbott lowered its outlook for COVID testing sales this year to $1.5 billion from the $2 billion it forecast in January.
[1/2] Boxes of Abbott's heart stents are pictured inside a store at a hospital in New Delhi, India, April 27, 2018. REUTERS/Adnan AbidiApril 19 (Reuters) - Abbott Laboratories (ABT.N) reported quarterly profit above expectations on Wednesday, underpinned by sales of its diabetes care devices and an improved demand for other devices due to a resumption in non-urgent medical procedures. The upbeat sales of Abbott's medical devices mirror a trend seen by rival Johnson & Johnson (JNJ.N), which also posted better-than-expected sales for the business on Tuesday. Sales of medical devices - Abbott's largest segment - grew 8.5% to $3.90 billion, of which $1.2 billion worth revenue was clocked in by glucose monitoring device Freestyle Libre. Abbott, which witnessed first-quarter sales worth $730 million in global COVID-19 test kits, slashed its annual revenue forecast for these devices to $1.5 billion from $2 billion.
WASHINGTON, April 19 (Reuters) - The U.S. Supreme Court on Wednesday faces a self-imposed deadline to act before significant limits on access to the abortion pill mifepristone take effect in a challenge by anti-abortion groups to the drug's federal regulatory approval. The Supreme Court, which has a 6-3 conservative majority, is expected to act before the deadline to either grant or reject the requests or further pause the litigation. In a case that could undercut federal regulatory authority over drug safety, the New Orleans-based 5th U.S. The 5th Circuit did halt a part of Kacsmaryk's order that would have suspended the U.S. Food and Drug Administration (FDA) approval of the drug in 2000 and effectively pull it off the market. Some 56% of respondents said they have an unfavorable view of the Supreme Court.
Shares of Abbott Laboratories popped Wednesday after the company's earnings and revenue topped Wall Street's expectations, defying a dramatic slowdown in sales of its Covid-19 tests. Abbott reported revenue of $9.7 billion for the first quarter, slightly surpassing the Refinitiv estimate of $9.64 billion due to recovery in its medical devices business. Strong sales in Abbott's medical devices business fueled the company's first-quarter beats. The unit raked in $3.9 billion in sales during the quarter, up nearly 9% from the same period last year. That comes after rival Johnson & Johnson reported strong growth in its own medical devices unit, noting that surgical procedures are "well in recovery."
WASHINGTON, April 18 (Reuters) - The U.S. Supreme Court should restrict the availability of the abortion pill mifepristone, anti-abortion groups challenging the medication's federal regulatory approval told the justices in a filing on Tuesday, urging them to implement curbs ordered by a conservative federal judge in Texas. Mifepristone is taken with another drug called misoprostol to perform medication abortion, which now accounts for more than half of all U.S. abortions. The Supreme Court has a 6-3 conservative majority. Anti-abortion groups led by the recently formed Alliance for Hippocratic Medicine and four anti-abortion doctors sued the FDA in November seeking to reverse approval of mifepristone. Since last year's Supreme Court decision, 12 U.S. states have put in place outright bans while many others prohibit abortion after a certain length of pregnancy.
Johnson & Johnson (JNJ) earnings Q1 2023
  + stars: | 2023-04-18 | by ( Annika Kim Constantino | ) www.cnbc.com   time to read: +5 min
Johnson & Johnson shares fell Tuesday after the company reported adjusted earnings and revenue that topped Wall Street's expectations, but lowered its sales guidance for its pharmaceutical business. J&J is now forecasting 2023 sales of $97.9 billion to $98.9 billion, about $1 billion higher than the guidance provided in January. Lawsuits allege the company's talc products were contaminated with the carcinogen asbestos, which caused ovarian cancer in thousands of individuals. Some suits link several deaths to J&J's talc products. Read the full J&J earnings report.
A Supermodel SuesIn 2021, Ms. Evangelista, one of the most recognizable supermodels of the 1980s and ’90s, said she had gone into a long seclusion after developing P.A.H. Ms. Evangelista declined to comment for this article. received over 1,100 reports of adverse events from CoolSculpting treatments — more than in the entire previous decade. was, she would work out constantly, trying to lose the fat that had emerged after CoolSculpting. Research was contributed by Sheelagh McNeill , Kitty Bennett , Alain Delaquérière , Kirsten Noyes and Jack Begg .
Danco Laboratories, the manufacturer of mifepristone, also asked the U.S. Supreme Court for similar relief on Friday. The Supreme Court has a 6-3 conservative majority. The administration said the lower court orders would have "sweeping consequences" for women who need access to mifepristone and the FDA's scientific judgment authority over drug safety. "The resulting disruption would deny women lawful access to a drug FDA deemed a safe and effective alternative to invasive surgical abortion," the Justice Department told the justices. Since last year's Supreme Court decision, 12 U.S. states have put in place outright bans while many others prohibit abortion after a certain length of pregnancy.
Total: 25