AngioDynamics (NSDQ:ANGO) today announced the FDA has approved its investigational device exemption application for its NanoKnife irreversible electroporation pilot study. The non-randomized pilot study will include six subjects at up to three sites and is designed to inform the design of a pivotal clinical study in the U.S. to help support the company’s bid for pre-market […]
Ocular Therapeutix OTX-TP trial misses primary endpoint
A Phase 3 clinical trial of the ORX-TP eye insert made by Ocular Therapeutix (NSDQ:OCUL) failed to meet the primary endpoint of significant superiority in the reduction of intraocular pressure. OTX-TP is an intracanalicular insert that delivers a preservative-free formulation of travoprost to reduce intraocular pressure. The randomized, double-blind, placebo-controlled clinical trial took place across more […]
DarioHealth prices $7m public offering
DarioHealth today priced an underwritten public offering of 4.8 million shares of common stock at 60¢ per share with additional pre-funded warrants. Pre-funded warrants offer 7.2 million shares of common stock at 59¢ each for gross proceeds of roughly $7.2 million. Get the full story on our sister site, Drug Delivery Business.
FDA warns against using ‘hacked’ diabetes devices
The FDA is warning the public against using unauthorized devices for diabetes management. After a report of a serious adverse event from a patient using an unauthorized device, the FDA is concerned about hacked devices used alone or with other authorized devices. In the report, a patient used an unauthorized device that received an electronic […]
How IoT is affecting connected medical device designs
By Joe Fegelman and Natalie Shortt, Emergo Group In the established landscape of the design of digital products, software and UI/UX design is generally broken down into two formats: desktop and mobile. For years, user interactions with “connected” medical devices have revolved around PCs and, more recently, mobile phones and smart televisions. Get the full […]
8 BIOMEDevice exhibitors you should know
BIOMEDevice Boston is one of the largest medical device manufacturing tradeshows in New England The annual event— held at the Boston Convention and Exhibition Center, May 15–16 — provides an opportunity for more than 4,000 engineers and executives and 400 suppliers in the region’s design and manufacturing industry to connect and network. Hundreds of medical […]
Ocular Therapeutix escapes SEC probe
The SEC recently closed its probe into Ocular Therapeutix (NSDQ:OCUL) and found no wrongdoing in the investigation. Ocular Therapeutix received a subpoena from the SEC on Dec. 15, 2017, for documents and information pertaining to its Dextenza 0.4mg and related communication with the FDA, investors and other parties. The company received a second subpoena on Aug. 21, […]
FDA issues final Q-Submission guidance to include medical device cybersecurity coverage
By Stewart Eisenhart, Emergo Group Finalized US Food and Drug Administration guidance for its Q-Submission (Q-Sub) Program whereby manufacturers solicit feedback from the agency prior to submitting their premarket applications now includes recommendations for cybersecurity-related issues. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the […]
Ocular Therapeutix posts wider-than-forecast Q1 losses
Ocular Therapeutix (NSDQ:OCUL) posted first-quarter results today that were wider than the consensus on Wall Street, missing the earnings consensus and beating on revenue. The Bedford, Mass.-based company reported losses of -$17.1 million, or -45¢ per share, on sales of $492,000 for the three months ended March 31, widening its losses by 24.4% on sales growth […]
Canadian regulators recommend 3D-printed medical device license applicants
By Stewart Eisenhart, Emergo Group Health Canada has published new guidance for manufacturers of higher-risk 3D-printed medical devices regarding what to include in their Medical Device License (MDL) applications and commercialize in the country. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only […]
Report: Google’s AI is better at spotting early lung cancer than doctors
Google developers said this week that the company has trained algorithms to analyze CT scans to find early signs of lung cancer. At the Google I/O developer conference, Google said its AI model could identify early signs of lung cancer in patients who later developed the disease despite five out of six radiologists missing the […]