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 […]
7 innovations that made nurses’ jobs easier
There are approximately 4 million registered nurses in the U.S., according to the American Nurses Association. As the heart of every hospital, nurses have to handle different patients and situations on a daily basis and are pivotal to the healthcare setting across the globe. I asked veteran nurses who have taken care of a wide […]
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 2018. […]
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