FREMONT, Calif., Nov. 20, 2020 /PRNewswire/ — THINK Surgical, an innovator in the field of orthopedic active robot surgery, announced today that the Food and Drug Administration (FDA) has cleared the second-generation of the TSolution One Total Knee […]
Tag: FDA
FDA clears Think Surgical’s second-gen robotic knee surgery system
Think Surgical announced today that FDA has granted 510(k) clearance for the second generation of its TSolution One total knee application. The TSolution One is an active robot for total knee replacement; it includes fully […]
THINK Surgical® Receives FDA Clearance of Second-Generation Active Robot
FREMONT, Calif., Nov. 20, 2020 /PRNewswire/ — THINK Surgical, an innovator in the field of orthopedic active robot surgery, announced today that the Food and Drug Administration (FDA) has cleared the second-generation of the TSolution One […]
Lantheus Holdings Announces FDA Clearance for AI-Enabled Automated Bone Scan Index (aBSI) in Prostate Cancer on GE Healthcare’s Xeleris Platform
NORTH BILLERICA, Mass.-(BUSINESS WIRE)-Lantheus Holdings, Inc. (the “Company”) (NASDAQ: LNTH), the parent company of Lantheus Medical Imaging, Inc., Progenics Pharmaceuticals, Inc., and EXINI Diagnostics AB, and a global leader in the development, manufacture and commercialization […]
'Major Victory': Federal Court Rejects FDA Approval of 'Frankenfish' - EcoWatch
‘Major Victory’: Federal Court Rejects FDA Approval of ‘Frankenfish’ EcoWatch Source link
MIRA surgical robot from Virtual Incision gets exemption from the FDA
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Belcampo beefs up portfolio with organic meatballs and carnitas | 2021-10-27
OAKLAND, CALIF. – Belcampo, a producer of better-for-you meats, broths and jerky, is introducing fully cooked organic carnitas and meatballs. Belcampo Organic Carnitas and Organic Meatballs are made with grass-fed and finished, USDA Certified Organic and […]
Why the FDA Is Warning Pregnant Women Not to Use Over-the-Counter Pain Relievers
By C. Michael White, University of Connecticut The Food and Drug Administation issued a warning on Oct. 15, 2020 to both health care professionals and women about the use of nonsteroidal anti-inflammatory drugs (NSAIDs) after […]
Baylor Scott & White-Frisco adds augmented reality guidance system for spine surgeries
The surgical guidance system allows Baylor Scott & White Medical Center-Frisco surgeons to use augmented reality to see patients’ spinal anatomy in three dimensions. (Courtesy Baylor Scott & White Medical Center-Frisco) Baylor Scott & White […]
The dirt on soil and why it matters | 2021-10-13
CHICAGO – For the past 10 years, Kristy Lewis, founder and chief executive officer of the snack company Quinn, Louisville, Colo., has been on a mission to create the future of food. Through her commitment […]
BD’s automated flow cytometry system wins FDA clearance
[Image courtesy of BD] Becton Dickinson (NYSE:BDX) today announced it has received 510(k) clearance from the FDA for its FACSLyric flow cytometer with the integrated BD FACSDuet sample preparation system. The system enables clinical laboratories to […]
White House bars FDA commissioner from testifying before committee
The White House blocked FDA Commissioner Dr. Stephen Hahn from testifying before the Energy and Commerce Committee, Politico reported. Energy and Commerce Committee Chairman Democratic Rep. Frank Pallone, Jr. and Health Subcommittee Chairwoman Democratic Rep. […]
General Mills helps wheat supplier gain USDA organic certification | 2021-09-17
MINNEAPOLIS — Gunsmoke Farms, a supplier to General Mills, Inc., has received organic certification from the US Department of Agriculture’s National Organics Program, General Mills said on Sept. 17. Gunsmoke Farms, a 34,000-acre farm near […]
Martin Bauer acquires Core Botanica | 2021-09-08
SECAUCUS, NJ. — The Martin Bauer Group has acquired Core Botanica, a manufacturer of customized mint leaf products. The acquisition expands Martin Bauer’s portfolio of raw materials and botanical ingredients, servicing the food and dietary […]
Podcast: ‘Clean’ wine isn’t so clean; FDA blocks hemophilia gene therapy; Universal flu vaccine?
Actress Cameron Diaz and fashion entrepreneur Katherine Power are marketing a new brand of “clean” wine using long-debunked claims about the benefits of organic farming. The FDA has temporarily halted the approval of a gene […]
FDA Approves Automated Insulin System for Young Kids
(Image: Getty) Type 1 diabetes patients need to monitor their glucose levels throughout the day and inject insulin as needed. This can be stressful for young patients (and their parents), but the US Food and […]
FDA approves first automated insulin system for kids
Testing blood sugar frequently and administering insulin as needed throughout the day isn’t easy, especially if the individual with diabetes is a young child who can’t do it on their own yet. Now, there’s an […]
FDA Clears the XACT Robot for CT-Guided Percutaneous Procedures
The hands-free, tablet-sized robot with the potential to democratize percutaneous interventional procedures is on the verge of disrupting the U.S. interventional radiology market. After winning FDA clearance last year for its first robotic system, XACT Robotics recently scored FDA […]
FDA approves unproven plasma treatment for COVID-19
The FDA on Sunday announced an emergency authorization for the use of convalescent plasma to treat COVID-19. The unproven treatment involves injecting plasma from people who have recovered into patients still fighting the coronavirus. The […]
Mark Meadows defended Trump calling FDA deep state
White House chief of staff Mark Meadows defended President Donald Trump describing the Food and Drug Administration as part of a “deep state” conspiracy that is slowing coronavirus treatment development to affect the November presidential […]
Trump attacks FDA on vaccine testing as he pushes for Nov. 3 rollout
President Trump attacked the US Food and Drug Administration in a tweet on Saturday, claiming the agency was “making it very difficult for drug companies to get people in order to test the vaccines and […]
FDA authorizes saliva-based coronavirus test funded by NBA, NBPA
The US Food and Drug Administration granted emergency use authorization to a saliva-based coronavirus test funded by the NBA and NBPA to be made available for public use, the agency announced Saturday. Unlike most other […]
J&J gets FDA breakthrough status for robot-assisted ablation device
Dive Brief: Johnson & Johnson has secured FDA breakthrough device designation for transbronchial microwave ablation technology using robot-assisted bronchoscopy, the company disclosed on Thursday. J&J moved into microwave ablation in 2016 through the takeover of NeuWave […]
FDA clears Neocis robot for full-arch dental implants
[Image courtesy of Neocis] Neocis said today that it has received FDA 510(k) clearance for its Yomi system for robot-assisted dental implant surgery. The clearance allows for a new splint attachment, which broadens Yomi’s application […]