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product approval

Apollo gains FDA approval for Polypropylene Suture-Anchor Assembly

Apollo Endosurgery has received 510(k) clearance from the FDA for its Polypropylene Suture-Anchor Assembly for use specifically with the OverStitch Endoscopic Suturing Systems. This proprietary suture-anchor implant is used as part of Apollo’s OverStitch and OverStitch Sx Endoscopic Suturing Systems to pass and anchor suture in the gastrointestinal tract.  The comapny is currently distributing a suture anchor that is manufactured by a third party according to Apollo design specifications.

FDA approves Ethicon’s Vistaseal Dual Applicator devices

Ethicon has received 510(k) clearance from the FDA for its Vistaseal open and laparoscopic Dual Applicators (35cm and 45cm), three next generation airless spray devices that combine biologics with device technology to address mild to moderate surgical bleeding. 

BAROnova gains FDA Approval for TransPyloric Shuttle Device

BAROnova has announced FDA approval for its the TransPyloric Shuttle (TPS) Device, a non-surgical weight loss solution for adult individuals with obesity with a BMI35.0-40.0 or a BMI of 30.0-34.9 with one or more obesity-related comorbid conditions and is intended to be used in conjunction with a diet and behaviour modification programme. 

FDA approves navigation system for the Obalon Balloon

Obalon Therapeutics, has received approval from the FDA of the Obalon Navigation System, which eliminates the need to use x-ray when placing the Obalon Balloon System. The Obalon Navigation System utilises magnetic resonance, rather than x-ray radiation, to image the Obalon Balloon during placement and displays a dynamic, real-time image of the Balloon on a notebook computer screen. 

Standard Bariatrics receives FDA clearance for Standard Clamp

Standard Bariatrics has received FDA clearance for the Standard Clamp, which according to the company, is a first-of-its-kind, disposable laparoscopic surgical clamp can assist surgeons performing laparoscopic sleeve gastrectomy, the most common and effective weight loss surgery. The company has begun commercial distribution of the product in the US.

Apollo gains special 510(k) clearance for OverStitch Sx System

Apollo Endosurgery has received Special 510(k) clearance from the FDA for the OverStitch Sx Endoscopic Suturing System. The OverStitch Sx System is a full-thickness flexible endoscopic suturing system, received initial 510(k) clearance in November 2017. The Special 510(k) addressed an accessory to the system that is intended to ease the attachment of the device to compatible endoscopes (single-channel endoscopes with diameters ranging from 8.8mm to 9.8mm). The Special 510(k) clearance is the last regulatory requirement needed prior to the system’s introduction into the US market.

Apollo’s Orbera365 approved in the Kingdom of Saudi Arabia

Apollo Endosurgery has announced that the Saudi Food and Drug Authority (SFDA) has approved the Orbera365 Managed Weight Loss System and has issued a Medical Device Marketing Authorization (MDMA) for the product. This MDMA allows Apollo Endosurgery to market Orbera365 in the Kingdom of Saudi Arabia with its exclusive distribution partner, AL-Nozha Medical. The Orbera365 Managed Weight Loss System doubles the indwell period from a six to a 12 month treatment period.

ReShape Balloon gains approval in Saudi Arabia

ReShape Lifesciences has announced approval of the company's ReShape Balloon by the Kingdom of Saudi Arabia Saudi Food and Drug Authority. Congruent with this approval, the company received an initial stocking order from Dar Al Zahrawi Medical.

Saudi Arabia has one of the highest obesity and overweight prevalence rates in the world, with close to 30% of the global population is estimated to be obese. In 2017, obesity rates in Saudi Arabia was estimated at 53% and is projected to grow to 60% by 2022 according to World Atlas.

Apollo gains South Korean approval for the Orbera Balloon System

Apollo Endosurgery has announced that the South Korean Ministry of Food and Drug Safety’s (MFDS) has approved of its Orbera Intragastric Balloon System to assist adult patients who are overweight with a BMI> 27 in losing and maintaining weight.

FDA clearance for Endoflip with Flip Topography Module

Crospon, an endoscopic diagnostics company, has received FDA clearance for its Endoflip System with Flip Topography Module, providing a new way for clinicians to assess patient motility disorders during endoscopy. This next generation of the Endoflip System, Endoflip 2.0, introduces imaging software that displays real-time oesophageal contractility patterns on a 24-inch touch-screen.

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