FDA Archives - Page 2 Of 13

Medical watch CardiacSense gets approval from Indian regulatory authority CDSCO – ET HealthWorld

16 February 2023 by Admin

New Delhi: Homegrown MedTech solutions provider Xplore Health on Thursday announced that it received approval from the Indian Regulatory Authority CDSCO (Central Drug Standard Control Organisation) under the Health Ministry of India for its aspirational medical smartwatch “CardiacSense“. The approval came ahead of its commercial launch in collaboration with Israeli Medtech company CardiacSense Ltd. The … Read more

Lupin Digital Health launches evidence-based holistic heart care programme LYFE, Health News, ET HealthWorld

25 January 2023 by Admin

Mumbai: Lupin Digital Health announced the launch of its digital therapeutics solution, LYFE, an evidence-based holistic heart care programme that significantly reduces the risk of a heart attack and improves vitals and quality of life for cardiac patients. Designed by leading Indian cardiologists, the programme helps patients improve their heart health through doctor-connected online and … Read more

Garmin brings ECG support to its smartwatches, Health News, ET HealthWorld

25 January 2023 by Admin

New Delhi: Garmin is finally allowing its users to take an electrocardiogram reading using their smartwatches. The company has announced its new ECG app and it is currently available in the US for users who happen to have a Venu 2 Plus smartwatch. The new app allows users to record heart rhythms and check for … Read more

US FDA clears Dozee’s contactless measurement system, Health News, ET HealthWorld

22 December 2022 by Admin

Bengaluru: Dozee announced its proprietary contactless vital signs (VS) measurement technology has received US FDA 510(k) clearance. According to nursing and midwifery professional organisations, India falls short of the WHO recommended rate of three nurses per 1,000 population and needs 4.3 million more nurses by 2024 to meet the WHO norms. Dozee aims to bridge … Read more

FDA Admits Flaws in Response to Infant Formula Shortage

21 September 2022 by Admin

By Cara Murez HealthDay Reporter HealthDay Reporter WEDNESDAY, Sept. 21, 2022 (HealthDay News) – In a report issued Tuesday, the U.S. Food and Drug Administration acknowledged numerous shortcomings in its response to the infant formula shortage earlier this year. “For things that are critical to the public health, if you don’t … Read more

IIIT-Delhi researchers develop AI-based model to detect carcinogens in chemical structures – ET HealthWorld

19 September 2022 by Admin

New Delhi: Researchers from IIIT-Delhi have developed an Artificial Intelligence-based model to detect carcinogens in chemical structures, which could have importance for the pharma industry for the screening of new drugs. The research on the software, named as Metabokiller, has also been published in Nature Chemical Biology, which is one of the most reputed journals … Read more

FDA Approves Botox Competitor That Lasts Longer

10 September 2022 by Admin

FRIDAY, Sept. 9, 2022 (HealthDay News) — People wanting to keep wrinkles at bay will soon have a new option now that the U.S. Food and Drug Administration has approved the first competitor for Botox in decades. Daxxify, made by Revance Therapeutics Inc. in Nashville, Tenn., is injected into the face along worry … Read more

Juul to Pay $438.5 Million for Its Role in Teen Vaping Crisis

8 September 2022 by Admin

Juul to Pay 8.5 Million for Its Role in Teen Vaping Crisis

By Cara Murez HealthDay ReporterHealthDay Reporter WEDNESDAY, Sept. 7, 2022 (HealthDay News) – Juul Labs said Tuesday it will pay $438.5 million, without acknowledging wrongdoing, to settle dozens of lawsuits filed over company practices that may have fueled widespread vaping among American teens. “This settlement with 34 states and territories is a significant part of … Read more

FDA Warns of Dangers From Skin Lightening Creams

2 September 2022 by Admin

THURSDAY, Sept. 1, 2022 (HealthDay News) — Skin lightening products can be dangerous for consumers when they contain harmful ingredients that are illegal for over-the-counter sales, the U.S. Food and Drug Administration warned Wednesday. The potentially harmful ingredients are hydroquinone or mercury, the agency said in a news release. People who have … Read more

FDA Authorizes Updated COVID Boosters to Target Newest Variants

31 August 2022 by Admin

Aug. 31, 2022 – The FDA on Wednesday granted emergency use authorization to Omicron-specific COVID-19 vaccines made by Pfizer/BioNTech and Moderna. The agency cited data to support the safety and efficacy of this next generation of mRNA vaccines targeted toward variants of concern. If you’ve been waiting to get a variant-specific booster shot, you may … Read more