Obalon Gas-Filled Balloon Not Subject of Fourth FDA Letter to Health Care Providers Related To Serious Risks, Including Death, With Liquid-Filled Intragastric Balloons Posted on 04/28/2020 10

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2017-09-18 · In a trial involving 255 patients, individuals receiving the Orbrera device “lost an average of 21.8 pounds (10.2% of their body weight) after the device had been in place for six months,” 2020-04-28 · Obalon Gas-Filled Balloon Not Subject of Fourth FDA Letter to Health Care Providers Related To Serious Risks, Including Death, With Liquid-Filled Intragastric Balloons Obalon reported no device Obalon Therapeutics (NSDQ:OBLN) said last week that it treated the first patients at its company-owned Obalon Center for Weight Loss in San Diego.. The San Diego-based company produces an FDA Obalon® Touch™ Inflation Dispenser Gas-Filled Balloon •~10 minutes with no anesthesia or sedation •X-ray free imaging for placement •Light, buoyant and durable •Well-tolerated & strong safety profile Obalon® Navigation System™ •Simple, reliable inflation 9 August 2019 The components of the Obalon system: Obalon Therapeutics has 34 employees at their 1 location and $1.59 M in annual revenue in FY 2020. See insights on Obalon Therapeutics including office locations, competitors, revenue, financials, executives, subsidiaries and more at Craft. Information regarding Obalon's directors and executive officers is contained in Obalon's annual report on Form 10-K and Form 10-K/A for the fiscal year ended December 31, 2020, which were filed SAN DIEGO, June 19, 2020 -- Obalon Therapeutics, Inc. (Nasdaq: OBLN), a weight loss solutions company with the first and only FDA-approved swallowable, gas-filled intragastric. Obalon Gas-Filled Balloon Not Subject of Fourth FDA Letter to Health Care Providers Related To Serious Risks, Including Death, With Liquid-Filled Intragastric Balloons PRESS RELEASE GlobeNewswire Obalon Gas-Filled Balloon Not Subject of Fourth FDA Letter to Health Care Providers Related To Serious Risks, Including Death, With Liquid-Filled Intragastric Balloons Posted on 04/28/2020 10 2020-04-28 · Obalon Gas-Filled Balloon Not Subject of Fourth FDA Letter to Health Care Providers Related To Serious Risks, Including Death, With Liquid-Filled Intragastric Balloons Obalon is the FIRST and ONLY swallowable, FDA-approved balloon system for weight loss. The Obalon Balloon System helps facilitate weight loss by taking up space in your stomach so you eat less.

Obalon deaths

The System is intended to be used as an adjunct to a moderate intensity diet and behavior modification program. The Obalon Balloon System is intended for adults with a body mass index (BMI) of 30 to 40 kg/m 2 willing to follow a diet and exercise program. All Obalon balloons must be removed in 6 months. Patients with prior weight loss surgeries are not eligible. Information regarding Obalon's directors and executive officers is contained in Obalon's annual report on Form 10-K and Form 10-K/A for the fiscal year ended December 31, 2020, which were filed About Press Copyright Contact us Creators Advertise Developers Terms Privacy Policy & Safety How YouTube works Test new features Press Copyright Contact us Creators Obalon, on the other hand, is a balloon “system”. The Obalon system is made up of 3 smaller balloons that are placed at separate appointments.

20 Jan 2021 The urgent warning comes less than a month after the exercise equipment maker itself released news of a child's death by a Peloton Tread+ and

Information regarding Obalon's directors and executive officers is contained in Obalon's annual report on Form 10-K and Form 10-K/A for the fiscal year ended December 31, 2020, which were filed About Press Copyright Contact us Creators Advertise Developers Terms Privacy Policy & Safety How YouTube works Test new features Press Copyright Contact us Creators Obalon, on the other hand, is a balloon “system”. The Obalon system is made up of 3 smaller balloons that are placed at separate appointments. The Obalon balloons are filled with gas instead of saline. Both types of balloons usually result in a substantial improvement in weight loss, when compared to diet and exercise alone.

10 May 2016 Risk of death (rare). There is a risk of the complications of perforation or obstruction from the gastric balloon or aspiration pneumonia from

A third type of balloon, the Obalon (which is filled with air), has also recently been The Obalon balloon system has the potential to provide patients and physicians or abuse associated with our product, could result in patient injury or death.

In August 2017, the FDA issued a warning after 5 11 Aug 2017 Four of the deaths involved people using the Orbera Intragastric Balloon we do not know the root cause or incidence rate of patient death, nor 6 days ago Detailed price information for Obalon Therapeutics Inc (OBLN-Q) from The Globe and Mail including charting and trades. Real-time Price Updates for Obalon Therapeutics Inc (OBLN-Q). Charting, Tear Sheets, Press, Price Performance & more. 21 Jan 2014 Unlike other gastric balloon treatments, Obalon does not require invasive surgery .
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One reported death involved a patient outside the U.S. who Four of the five newly reported deaths involved the Orbera device. Of the 12 total deaths, seven were U.S. patients, the FDA says. Gastric perforation, when a hole forms in the wall of the stomach, Obalon has not received any reports of any deaths related to the use of Obalon Six-Month Balloon System since it was launched in January 2017. Since launching the Obalon Balloon in January 2017, Obalon has worked methodically and diligently in an effort to enable the best outcomes for patients.

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Obalon Announces Fourth Quarter and Full Year 2020 Financial Results SAN DIEGO , March 12, 2021 (GLOBE NEWSWIRE) -- Obalon Therapeutics, Inc. (NASDAQ:OBLN), a vertically integrated medical technology company with the first and only FDA-approved swallowable, gas-filled intragastric balloon system for the treatment of obesity, today announced its financial results for

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Obalon Therapeutics (NSDQ:OBLN) today touted that it has never received a report of a death related to the use of its Obalon six-month gas-filled gastric balloon system designed to aid in weight

Gastric perforation, when a hole forms in the wall of the stomach, Obalon has not received any reports of any deaths related to the use of Obalon Six-Month Balloon System since it was launched in January 2017. Since launching the Obalon Balloon in January 2017, Obalon has worked methodically and diligently in an effort to enable the best outcomes for patients. The Company provides Obalon Product Specialists, whom are separate from the sales function, to help providers utilize the Obalon Balloon in a safe and effective manner.

The balloons were removed in late June — an endoscopic procedure performed under general anesthesia — and I've remained within five pounds of the 185 pounds Dana Goossens, 29, lives in Illinois and participated in a recent clinical trial for a weight loss device called the Obalon Balloon System. Here’s her story: 2019-05-22 · Average weight loss for patients receiving three balloons and six months of therapy was 21.7 pounds, reducing total body weight by 10.2%. Non-serious side effects occurred in 10.3% of patients Obalon Therapeutics provided further clarification that it's gas-filled balloon is not the subject of the April 27, 2020 letter issued by the FDA to health care providers warning of serious potential risks, including deaths, associated with the use of liquid-filled intragastric balloons.