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Reports about industry: product launches, accreditations, etc.

TransEnterix sells AutoLap image-based positioning system to GBIL

TransEnterix, a medical device company that is digitising the interface between the surgeon and the patient to improve minimally invasive surgery, has announced the sale of certain AutoLap image-based laparoscope positioning system (AutoLap) assets to Great Belief International Limited (GBIL), for total proceeds of US$47.0 million.

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. 

Spatz3 balloon has highest success rates of all gastric balloons

For the first time, a safe non-surgical out-patient weight loss treatment approaches the results of bariatric surgery. Spatz Medical has announced the FDA trial results of its innovative adjustable gastric balloon, the Spatz3 adjustable balloon. The results demonstrate that the Spatz3 balloon is significantly more effective than any non-adjustable balloon in the market.

"The idea for developing an adjustable balloon was triggered by two main challenges the industry has been facing," said Dr Jeffrey Brooks, CEO and inventor of the Spatz3 adjustable balloon.

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. 

Gelesis gains FDA approval for PLENITY hydrogel

Gelesis has gained FDA approval for its lead product candidate, PLENITY (Gelesis100), as an aid in weight management in adults with a BMI25–40, when used in conjunction with diet and exercise. According to the company, PLENITY represents a new prescription option for millions of adults. More than half of the approximately 150 million adults in the US with a BMI ranging from 25 to 40 are classified as overweight.

AspireAssist is endorsed by ASMBS

Aspire Bariatrics has received an endorsement from the American Society of the Metabolic and Bariatric Surgeons (“ASMBS”) for its AspireAssist system. The device consists of a low-profile implantable gastrostomy tube and a siphon system. Patients drain the contents of their stomachs after a meal, thereby reducing caloric absorption. The AspireAssist is given in conjunction with lifestyle therapy, in which patients are taught portion control, careful chewing, and other healthy lifestyle habits.

Novo Nordisk launches semaglutide once-weekly GLP-1 RA for T2DM

Novo Nordisk UK has announced that Ozempic (semaglutide), a once-weekly GLP-1 analogue injection1 for the treatment of type 2 diabetes is now available in the UK. According to the company, Ozempic works by mimicking the function of the GLP-1 (human glucagon-like peptide-1) hormone produced in the gut that lowers post-meal blood glucose levels and also slows glucose absorption into the bloodstream.

Apollo Endosurgery sells Lap-Band system to ReShape Lifesciences

Apollo Endosurgery has announced the sale of its surgical product line, which consists of the Lap-Band adjustable gastric banding system and other accessories used in laparoscopic bariatric surgery, to ReShape Lifesciences. The definitive transaction agreements were signed and closed on 17 December 2018. This transaction will allow Apollo to focus all its efforts on growing the clinical adoption of its Endo-bariatric product offerings, which consists of its OverStitch Endoscopic Suturing Systems and the Orbera Intragastric Balloon technologies.

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. 

GI Dynamics and Apollo Sugar to establish Indian EndoBarrier study

GI Dynamics entered into an agreement with Apollo Sugar to jointly study the safety and efficacy of EndoBarrier in India. The agreement between Apollo Sugar and GI Dynamics provides for the commencement of a clinical trial, pending appropriate regulatory submissions and approvals, that consists of 100 patients randomized into 75 EndoBarrier and 25 control patients with a 3-to-1 ratio. Subject to GI Dynamics raising additional capital, enrolment is expected to commence in the first half of 2019 and conclude by the end of the third quarter of 2019.

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