Gastroenterology
Genetic Analysis CEO Ronny Hermansen and Christina Casén, senior VP of clinical and medical affairs, discuss the company’s polymerase chain reaction (PCR)-based approach to gut microbiota profiling versus DNA sequencing, competitive landscape, and opportunities for supporting pharma R&D and assessing drug treatment success.
Announced in conjunction with a $97m Series D financing round, Neptune underscores its gastrointestinal focus and robotics aspirations by spinning out Jupiter Endovascular, which will leverage $21m of the funding to support ongoing development of its Endoportal Control technology.
A survey of over 1,000 patients worldwide found that the majority of patients agree that hospitals and endoscopists are responsible for mistakes made by devices that use AI.
In 2024, Visana Health will leverage $10.1m in seed funding to expand its holistic, value-based virtual clinic to add conditions that differently or disproportionally affect women and provide at-home testing. Health plans and employers are taking notice, and Visana’s CEO expects further investment to follow.
Olympus Medical has issued a recall of its High-Flow Insufflation Unit after reports of cardiac events during surgical procedures performed while using the device. The company has also requested providers stop using the device unless no alternative is available.
The Food and Drug Administration is providing patients with information on the pros and cons of hernia mesh surgery, a procedure that has come under intense scrutiny in recent years.
Medtronic, an investor in Allurion, will help distribute Allurion’s inflatable gastric balloon in specific regions.
During MD&M East in New York, Robert Austring, vice president of sales and marketing at Precision Optics, described the opportunities and challenges of marketing either reusable or single-use endoscopic devices.
The Federal Trade Commission said it supports Boston Scientific’s decision to walk away from a planned $230m acquisition of Korea-based MI Tech. Boston Scientific said it could not obtain needed global regulatory approvals.
Two Swedish companies are working on tackling GERD – one with a drug, one with a device.
The Indiana company is the latest medtech firm to announce that it is making broad headcount reductions to cut costs.
The US FDA has cleared a new endoscopy system from Olympus along with two compatible gastrointestinal endoscopes for the diagnosis and treatment of a range of GI issues.
The US FDA recently rebuked Tokyo-based medical device firm Olympus for failing to adhere to good manufacturing practices for its endoscopes and for not investigating complaints related to the devices.
Allurion markets the Allurion Program, a unique temporary gastric balloon treatment paired with a digital health platform to support weight loss. Supported by $70m in new money from a merger with Compute Health Acquisition Corporation, the company hopes to submit a PMA to the FDA for system later this year.
This new Medtech Insight feature compiles news briefs on a range of US regulatory and legal happenings. This week: Congressional criticism of ClinicalTrials.gov, new radiation device performance standards, clearance of a new sepsis test and two new device classifications.
The US Food and Drug Administration issued warning letters in 2022 to Japanese device maker Olympus Medical Systems Corporation and a subsidiary concerning good manufacturing practices related to its endoscopes.
In this month’s Digital Health Roundup, Medtech Insight’s Marion Webb provides highlights from the recent HLTH conference in Las Vegas. Reed Miller and Barnaby Pickering offer an overview of the highly competitive diabetes tech market. We also talk about digital health in Germany and Europe.
The company has developed a highly-customizable polymer that can repair tissue, negating the need for stitches and staples, for use in multiple applications.
Two Massachusetts-based infusion pump manufacturers with the same founder and CEO received warning letters from the US FDA for similar violations.
People with obesity now have new tools to help them lose weight, thanks to the US agency’s de novo authorization.