Observation

Sol-Millennium Responds to FDA’s Warning Letter and Safety Communication

Retrieved on: 
Thursday, March 21, 2024
Medical Devices, FDA, Health, Other Health, Pharmaceutical, Biotechnology, Communication, Letter, Knowledge, Observation, Nature, Syringe, Potential, Needle, Safety, ISO, Medical device

Sol-Millennium, manufacturer of medical devices, including syringes for medicine delivery and testing, issued a statement regarding March 19th update to the FDA’s Safety Communication (“Evaluating Plastic Syringes Made in China for Potential Device Failures”) and a Warning Letter to Sol-Millennium.

Key Points: 
  • Sol-Millennium, manufacturer of medical devices, including syringes for medicine delivery and testing, issued a statement regarding March 19th update to the FDA’s Safety Communication (“Evaluating Plastic Syringes Made in China for Potential Device Failures”) and a Warning Letter to Sol-Millennium.
  • Since November 2023, Sol-Millennium has been providing reports of actions it has taken to address any findings identified in the Warning Letter.
  • The principal focus of the Warning Letter is on our 510(k) and whether our “combination” products (needle + syringe attached) constitute a significant change or modification in design that could significantly alter the safety and effectiveness of the devices.
  • These are the two manufacturers cited in the FDA’s Safety Communication Letter that the FDA recommends to “Immediately transition away from using plastic syringes manufactured” by these manufactures… “[because of] potential quality and performance issues”.

Collette Health Appoints Christine Gall as Chief Nursing Officer

Retrieved on: 
Tuesday, March 19, 2024
Nursing, Practice Management, Technology, Managed Care, Health, General Health, Health Technology, Other Technology, Hospitals, Telemedicine, Virtual Medicine, Hardware, Engagement, Champaign–Urbana metropolitan area, Risk, Business administration, Gall, Patient, Knowledge, Hospital, Observation, Science, University, Life, Doctor of Public Health, BSN, Safety, Multimedia, Bachelor, Patient safety

Collette Health , a leading provider of virtual patient observation solutions, is pleased to announce the appointment of healthcare visionary Christine Gall DrPH, MS, BSN, as chief nursing officer.

Key Points: 
  • Collette Health , a leading provider of virtual patient observation solutions, is pleased to announce the appointment of healthcare visionary Christine Gall DrPH, MS, BSN, as chief nursing officer.
  • View the full release here: https://www.businesswire.com/news/home/20240319551571/en/
    Collette Health appoints Christine Gall DrPH, MS, BSN as chief nursing officer.
  • (Photo: Business Wire)
    Gall brings three decades of experience and a wealth of knowledge in Patient Safety and Engagement, Quality, and Public Health Leadership.
  • “I’m thrilled to be joining Collette Health at such a pivotal time as we see the role of clinicians evolve and new technology transform the healthcare industry,” said Gall.

Natera Announces Phase III Randomized CIRCULATE Trial in France, Evaluating Signatera™ in Stage II Colorectal Cancer

Retrieved on: 
Monday, March 18, 2024
Science, Other Science, Biometrics, Biotechnology, Oncology, Health, Genetics, Clinical Trials, ACT, Cordeliers, Survival, Colorectal cancer, Patient, DNA, Observation, Standard of care, Doctor of Philosophy, MD, FOLFOX, Gastroenterology, Circulating tumor DNA, NTRA, CRC, MRD, Neoplasm, Nursing

The study’s main objective is to determine the benefit of adjuvant chemotherapy (ACT) in stage II CRC patients with detectable circulating tumor DNA (ctDNA) post-surgery.

Key Points: 
  • The study’s main objective is to determine the benefit of adjuvant chemotherapy (ACT) in stage II CRC patients with detectable circulating tumor DNA (ctDNA) post-surgery.
  • Patients who are Signatera MRD-positive will be randomized to receive ACT (FOLFOX 6m) or pursue observation (no chemotherapy).
  • While the Japanese and U.S. trials evaluate the benefit of MRD-guided treatment in stage III and high-risk stage II CRC patients, the French trial is focused on stage II CRC.
  • “We believe this randomized study could establish a new standard of MRD-guided care in stage II colorectal cancer, potentially improving treatment decisions for thousands of patients.”
    Natera has joined the study in progress.

SONIC Celebrates Upcoming Total Solar Eclipse with New Limited-Edition Blackout Slush Float

Retrieved on: 
Monday, March 18, 2024
Retail, Other Consumer, Consumer, Restaurant, Bar, Specialty, Food, Beverage, Eclipse, BBQ, International Organization (journal), Lettuce, International Space Station, Candy, Moon, Observation, Learning, SONIC, City, NASA, DonorsChoose, Cheese, ISS, Fruit, Safety, Multimedia, ISO, Communications satellite

Guests will also receive one free pair of solar eclipse viewing glasses* with every purchase of the Blackout Slush Float, while supplies last, to help safely watch the eclipse and create fun memories of this momentous occasion.

Key Points: 
  • Guests will also receive one free pair of solar eclipse viewing glasses* with every purchase of the Blackout Slush Float, while supplies last, to help safely watch the eclipse and create fun memories of this momentous occasion.
  • View the full release here: https://www.businesswire.com/news/home/20240318899054/en/
    SONIC Celebrates Upcoming Total Solar Eclipse with New Limited-Edition Blackout Slush Float (Photo: Business Wire)
    Featuring a sweet, cotton candy and dragon fruit flavored, all-black slush representing the temporary darkness from the solar eclipse and topped with creamy white soft serve and blue and purple galaxy-themed sprinkles, the Blackout Slush Float will transport fans straight to outer space.
  • SONIC is also partnering with former NASA astronaut, International Space Station commander and SONIC superfan, Terry Virts, to share tips on how to best enjoy the total solar eclipse.
  • Guests planning to view the eclipse from SONIC should get their branded eclipse viewing glasses, free with every Blackout Slush Float purchase, in advance since supply is limited.

Coinbase Announces Pricing of Upsized Offering of $1.1 Billion of 0.25% Convertible Senior Notes Due 2030

Retrieved on: 
Thursday, March 14, 2024
Professional Services, Blockchain, Technology, Cryptocurrency, Finance, Electronic Commerce, Banking, Exercise, Sale, Observation, Public expenditure, Convertible, Investment, Note, Debt-to-GDP ratio, Person, Security (finance)

The aggregate principal amount of the offering was increased from the previously announced offering size of $1.0 billion.

Key Points: 
  • The aggregate principal amount of the offering was increased from the previously announced offering size of $1.0 billion.
  • Coinbase also granted the initial purchasers of the notes a 30-day option to purchase up to an additional $165.0 million principal amount of notes, solely to cover over-allotments.
  • If the initial purchasers exercise their option to purchase additional notes, Coinbase expects to use a portion of the net proceeds from the sale of such additional notes to enter into additional capped call transactions.
  • No sinking fund is provided for the notes, which means that Coinbase is not required to redeem or retire the notes periodically.

Merck Announces Plans to Conduct Clinical Trials of a Novel Investigational Multi-Valent Human Papillomavirus (HPV) Vaccine and Single-Dose Regimen for GARDASIL®9

Retrieved on: 
Wednesday, March 13, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, MSD, Hypersensitivity, Pregnancy, Wart, Head, Congress, Recombinant, Multiple endocrine neoplasia, Dizziness, Safety, Vain, Headache, Bruise, Public, Syncope, Ageing, Merck & Co., Cervical intraepithelial neoplasia, Vulvar intraepithelial neoplasia, Anal cancer, Virus-like particle, Observation, CIN, Thigh, Human, HPV, Plant, Vaginal intraepithelial neoplasia, Nausea, MRK, VLP, Investment, Immunity, Fever, Erythema, Vaccination, Injury, Vaccine, Allergy, Itch, AIN, Swelling

Separately, the company also plans to conduct clinical trials in both females and males to evaluate the efficacy and safety of a single-dose regimen of GARDASIL®9 (Human Papillomavirus 9-valent, recombinant), compared to the approved three-dose regimen.

Key Points: 
  • Separately, the company also plans to conduct clinical trials in both females and males to evaluate the efficacy and safety of a single-dose regimen of GARDASIL®9 (Human Papillomavirus 9-valent, recombinant), compared to the approved three-dose regimen.
  • Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
  • The latest addition to the pipeline employs the company’s proprietary virus-like particle (VLP) technology to incorporate additional VLPs for expanded HPV type coverage.
  • These randomized, double-blind, multi-year clinical trials will examine the short and long-term efficacy and immunogenicity of a single-dose of GARDASIL 9 versus the currently approved three-dose regimen.

Coinbase Announces Proposed Private Offering of $1.0 Billion of Convertible Senior Notes Due 2030

Retrieved on: 
Tuesday, March 12, 2024
Professional Services, Blockchain, Technology, Cryptocurrency, Finance, Electronic Commerce, Banking, Exercise, Sale, Observation, Public expenditure, Convertible, Investment, Note, Debt-to-GDP ratio, Person, Security (finance)

Coinbase also expects to grant the initial purchasers of the notes a 30-day option to purchase up to an additional $150.0 million principal amount of notes solely to cover over-allotments.

Key Points: 
  • Coinbase also expects to grant the initial purchasers of the notes a 30-day option to purchase up to an additional $150.0 million principal amount of notes solely to cover over-allotments.
  • The notes will be senior, unsecured obligations of Coinbase, will accrue interest payable semi-annually in arrears and will mature on April 1, 2030, unless earlier repurchased, redeemed or converted.
  • The notes will be convertible into cash, shares of Coinbase’s Class A common stock, or a combination thereof, at Coinbase’s election.
  • The interest rate, initial conversion rate, and other terms of the notes are to be determined upon pricing of the offering.

United States Video Game Market Size and Forecasts Report 2024: A $196.61 Billion Industry by 2030 from $96.67 Billion in 2023 - Trends, Growth, Share, Outlook, Impact of Inflation, Opportunity - ResearchAndMarkets.com

Retrieved on: 
Monday, March 11, 2024
Internet, Online, Consumer Electronics, Technology, Apps, Applications, Electronic Games, Mobile, Wireless, Entertainment, Cloud, Video game, VR, ESA, Video, Female, Observation, Traction, Parent, Virtual reality

The "United States Video Game Market, Size, Forecast 2024-2030, Industry Trends, Growth, Share, Outlook, Impact of Inflation, Opportunity Company Analysis" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "United States Video Game Market, Size, Forecast 2024-2030, Industry Trends, Growth, Share, Outlook, Impact of Inflation, Opportunity Company Analysis" report has been added to ResearchAndMarkets.com's offering.
  • The United States video game market size will reach US$ 196.61 Billion by 2030 US$ 96.67 Billion in 2023, growing at a CAGR of 10.67% from 2024 to 2030
    Video games make up one of the fastest-growing entertainment industries in the United States.
  • These factors have contributed to the mainstream popularity of video games as enjoyment, leading to a developing number of players.
  • According to an ESA observation, over 227 million players inside the United States area played video games last year.

Aohua Endoscopy's AQ-300 is Recognized as "Endoscopy Product Innovation Award" by the Healthcare Asia Medtech Awards 2024

Retrieved on: 
Friday, March 29, 2024
Biopsy, CBI, Health, ENT, Endoscopy, Observation, Urology, Gastroenterology, Telescopic sight

SINGAPORE, March 29, 2024 /PRNewswire/ --  Medical equipment manufacturing company Aohua Endoscopy clinched the Endoscopy Product Innovation Award at the recently held Healthcare Asia Medtech Awards 2024 for its development of the Aohua 4K AQ-300 video endoscopy system, which offers an improved endoscopic diagnosis and treatment option.

Key Points: 
  • SINGAPORE, March 29, 2024 /PRNewswire/ --  Medical equipment manufacturing company Aohua Endoscopy clinched the Endoscopy Product Innovation Award at the recently held Healthcare Asia Medtech Awards 2024 for its development of the Aohua 4K AQ-300 video endoscopy system, which offers an improved endoscopic diagnosis and treatment option.
  • The awards program recognizes outstanding medical technology companies in Asia that are influencing the transformation of healthcare by excelling in medical device innovation, service delivery, and patient care.
  • When used in conjunction with Aohua's magnification endoscope, AQ-300 can guarantee that the image is clear even at high magnification.
  • It features dual-frame display support, which enables simultaneous observation of the same location in modes with CBI and white light.

Global Ultra Wideband Chipset Market Report 2023-2028: New Application Areas in Wireless Sensor Network and Growing Deployment in Mobile Devices

Retrieved on: 
Monday, March 25, 2024
NXP Semiconductors, Growth, Apple, COVID-19, Risk, SWOT, Observation, Market development, Texas Instruments, Ansoff matrix, Investment, Zebra Technologies, Emotion

DUBLIN, March 25, 2024 /PRNewswire/ -- The "Global Ultra Wideband Chipset Market (2023-2028) Competitive Analysis, Impact of Covid-19, Ansoff Analysis" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • DUBLIN, March 25, 2024 /PRNewswire/ -- The "Global Ultra Wideband Chipset Market (2023-2028) Competitive Analysis, Impact of Covid-19, Ansoff Analysis" report has been added to ResearchAndMarkets.com's offering.
  • Market dynamics are forces that impact the prices and behaviors of the Global Ultra Wideband Chipset Market stakeholders.
  • The report presents a detailed Ansoff matrix analysis for the Global Ultra Wideband Chipset Market.
  • The report offers a comprehensive evaluation of the Global Ultra Wideband Chipset Market.