Dexcom (NSDQ:DXCM) said today that its G6 continuous glucose monitoring system will be covered for Medicare beneficiaries. The company’s product won coverage as a therapeutic CGM system, making it available to beneficiaries who closely manage their insulin dosing. Get the full story at our sister site, Drug Delivery Business News.
GI Dynamics eyes 2019 EU market return for EndoBarrier
GI Dynamics (ASX:GID) said yesterday that it tapped a new notified body in Europe, nearly a year after losing CE Mark approval there, as it eyes a market return for its EndoBarrier device by the end of next year. In the European Union, notified bodies are used as part of the regulatory system to assess product […]
Obalon Therapeutics wins FDA nod for Obalon Touch inflation system
Obalon Therapeutics (NSDQ:OBLN) said this week it won approval from the FDA for a premarket approval supplement application for its Obalon Touch inflation system. The newly cleared Obalon Touch is an automated system designed to inflate the Obalon balloon, a gas-filled balloon intended to promote weight loss in obese patients, the San Diego-based company said. “We […]
GI Dynamics raises $5 million for diabetes/obesity device
Investors have agreed to buy $5 million worth of GI Dynamics’ (ASX:GID) common stock, representing 6.9 million shares. The Lexington, Mass.-based company said it will use the money to fund the continued development of its EndoBarrier device and for general working capital. EndoBarrier is a plastic gut sleeve designed to treat type 2 diabetes and obesity […]
Obalon surges on $10m private placement
Obalon Therapeutics (NSDQ:OBLN) shares are up today after the weight loss device maker said it inked a private placement deal worth $10 million. San Diego-based Obalon, which makes a gas-filled balloon designed to promote weight loss in obese patients, said investors in the placement include “unaffiliated institutional investors, members of the Company’s management team and […]
GI Dynamics wins FDA nod for pivotal US EndoBarrier trial
GI Dynamics (ASX:GID) said today it won FDA investigational device exemption approval to launch a pivotal trial of its EndoBarrier device designed for treating patients with type 2 diabetes and obesity, pending Institutional Review Board approval. The EndoBarrier device is a plastic gut sleeve designed to prevent the absorption of nutrients from food as it exits the stomach and […]
Apollo Endosurgery prices $21m offering
Apollo Endosurgery today priced a stock offering worth nearly $21 million for its line of bariatric and gastrointestinal devices. Austin, Texas-based Apollo said it plans to float roughly 3.75 million shares at $5.50 apiece, for gross proceeds of $20.6 million. The offering also includes a 45-day option for underwriter Craig-Hallum Capital of another 562,055 shares, […]
ReShape Lifesciences raises $2m
ReShape Lifesciences (NSDQ:RSLS) said yesterday it inked approximately $1.5 million in offering deals with a number of institutional investors. The San Clemente, Calif.-based company said it will float 374,572 shares of its common stock at a price of $3.92 per share in the registered direct offerings. ReShape Lifesciences will also issue warrants for the purchase of […]
FDA warns of 5 new deaths from liquid-filled intragastric balloons
Updated to include response from Apollo Endosurgery The FDA today released a notice warning of five new patient deaths related to two liquid-filled intragastric balloon systems used to treat obesity, produced by Apollo Endosurgery (NSDQ:APEN) and ReShape Lifesciences (NSDQ:RSLS). The additional deaths bring the total number of deaths worldwide from the Orbera intragastric balloon and ReShape integrated […]
GI Dynamics touts insulin resistance improvement, weight loss in EndoBarrier meta-analysis
GI Dynamics (ASX:GID) today released results from a meta-analysis of its EndoBarrier device exploring its use in helping patients with type 2 diabetes and obesity, touting improvements in insulin resistance and positive changes in weight. The EndoBarrier device is a plastic gut sleeve designed to prevent the absorption of nutrients from food as it exits the stomach and […]
7 medtech stories we missed this week: April 27, 2018
From DuPuy Synthes’s spinal implant launch to Lumendi’s FDA clearance, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. DePuy Synthes launches spinal implants DePuy Synthes announced in an April 26 press release that it has launched its Proti 360º integrated titanium family of interbody devices that are designed […]
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