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CAPTION HEALTH: FDA Expedites Clearance of Caption Health …

WebCaption AI software in action showing a successful ultrasound. Caption Health issued the following announcement on May 12. In response to the growing body …

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URL: https://fdahealthnews.com/stories/536696635-caption-health-fda-expedites-clearance-of-caption-health-ultrasound-software-to-aid-frontline-healthcare-workers-in-fight-against-covid-19-pandemic

NOCTRIX HEALTH: Granted FDA Breakthrough Device Designation …

WebNoctrix Health, Inc. issued the following announcement on June 2. Noctrix Health, Inc., a privately held medical device company announced today that the US …

Category: Medical Go Health

INSMED: Receives FDA Breakthrough Therapy Designation for …

WebInsmed Incorporated issued the following announcement on June 8. Insmed Incorporated (Nasdaq:INSM), a global biopharmaceutical company on a mission to …

Category: Health Go Health

FDA: Launches the Digital Health Center of Excellence

WebU.S. Food and Drug Administration issued the following announcement on September 22. Today, the U.S. Food and Drug Administration announced it is launching …

Category: Food Go Health

CALA HEALTH: Receives FDA Breakthrough Device

WebCala Health, Inc. issued the following announcement on October 22. Cala Health, Inc., a bioelectronic medicine company developing wearable therapies for …

Category: Medicine Go Health

DIRECT BIOLOGICS: Granted Expanded Access by FDA for ExoFlo™ …

WebDirect Biologics issued the following announcement on October 13. Direct Biologics, LLC, announced today that the FDA has granted expanded access for ExoFlo …

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VIOME: Viome and Helomics Partner to Identify

WebViome issued the following announcement on March 21. Viome, a company transforming health through personalized nutrition based on individual biology, today …

Category: Nutrition Go Health

MEDTRONIC: Announces FDA Approval for MiniMed™ 770G

WebMedtronic plc issued the following announcement on September 1. Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced it has …

Category: Medical Go Health

ZEBRA MEDICAL VISION: Secures its First FDA Clearance in …

WebThis latest clearance makes Zebra Medical the first AI startup with six FDA clearances across three different modalities under its belt. In initial testing Zebra-Med …

Category: Medical Go Health

FDA Update: June facility inspection results FDA Health News

WebThe U.S. Food and Drug Administration inspects numerous facilities around the nation to ensure that they comply with current rules governing FDA-regulated products.

Category: Food Go Health

HEARTVISTA: Receives FDA 510(k) Clearance for One Click™ …

WebHeartVista issued the following announcement on Oct. 29. HeartVista, a pioneer in AI-assisted MRI solutions, today announced that it received 510(k) clearance …

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ACCURATE DIAGNOSTIC LABORATORIES: Adds Another Weapon …

WebAccurate Diagnostic Labs issued the following announcement on May 11. Accurate Diagnostic Labs, in collaboration with RUCDR Infinite Biologics, will continue to …

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FDA: Approves First Generic of a Commonly Used Albuterol …

WebThe U.S. Food and Drug Administration approved the first generic of Proventil HFA (albuterol sulfate) Metered Dose Inhaler, 90 mcg/Inhalation, for the treatment or …

Category: Food Go Health

GENEQUANTUM HEALTHCARE: World's first iLDC

WebGeneQuantum Healthcare issued the following announcement on June 11. GeneQuantum Healthcare (GQ) has recently received the US IND approval for its in …

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Bongo Rx may replace the CPAP for treatment of mild to …

WebBongo Rx may replace the CPAP for treatment of mild to moderate sleep apnea. More than 70 percent of 200 patients with mild to moderate sleep apnea …

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SECTRA, INC.: Sectra and Hospital for Special Surgery Collaborate …

WebSectra, Inc. issued the following announcement on April 7. International medical imaging IT and cybersecurity company Sectra (STO: SECT B) has gone live with …

Category: Medical Go Health

FIRSTKIND LTD: FDA Clears GEKO DEVICE for Use in Non-surgical …

WebFirstkind Ltd issued the following announcement on Oct. 10. UK-based medical devices company, Sky Medical Technology Ltd, has received U.S. Food and …

Category: Food, Medical Go Health

PHOSPHORUS: Announces FDA Approval Of At-Home Saliva Test …

WebPhosphorus issued the following announcement on June 8. Tests Facilitate Safe Clinical Care and Employer Health Programs, Also Available to General Public …

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POLYTECH HEALTH &amp; AESTHETICS GMBH: Welcomes …

WebPOLYTECH Health & Aesthetics GmbH, a global leader in breast aesthetics, welcomes a recent statement by the FDA that textured breast implants will …

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