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 […]
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. […]
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 […]
Cutera slides on Q1 reports, reiterates outlook
Cutera (NSDQ:CUTR) posted first-quarter results today that missed the consensus on Wall Street and made no changes to its guidance for the rest of the year. The Brisbane, Calif.-based company reported losses of -$8.2 million, or -59¢ per share, on sales of $36 million for the three months ended March 31, increasing its losses by 304.5% […]
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 […]
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 […]
Medtronic touts CGM study results
Medtronic (NYSE:MDT) today announced the results of its SMILE study that investigated the safety and effectiveness of its MiniMed 640G system with SmartGuard. The study was conducted in adults who have type 1 diabetes and are more prone to severe hypoglycemia. The SMILE study tested the MiniMed 640G insulin pump with SmartGuide to prevent low glucose […]
FDA clears RemUnity drug pump co-developed by Deka, United Therapeutics
United Therapeutics and Deka Research and Development have received FDA 510(k) clearance for the co-developed RemUnity system. The RemUnity system is a subcutaneous delivery system for Remodulin injections. The two companies have co-developed the device that is indicated to treat pulmonary arterial hypertension. “We developed the RemUnity system to address safety and patient convenience problems […]
Mylan shares fall on sales miss, swing to Q1 losses
Mylan (NSDQ:MYL) posted first-quarter results today that missed the consensus revenue forecast on Wall Street, sending its share prices down. The Canonsburg, Penn.-based company swung to red ink for the three months ended March 31, reporting losses of -$25 million, or -5¢ per share, on a -7.0% sales decline to $2.5 billion, compared with Q1 […]