TearLab Corp. (OTC:TEAR) said this week that the FDA ruled that the company’s 510(k) submission for its TearLab Discovery MMP-9 test, designed to measure an inflammatory biomarker found in tears, did not meet criteria for substantial equivalence. The San Diego-based company’s TearLab Discovery lab-on-a-chip platform is intended to analyze multiple biomarkers in human tears with nanoliter […]
TearLab Corp. (OTC:TEAR) said today that the FDA told the company it needs more information regarding its 510(k) application for the TearLab Discovery platform and test card designed to measure an inflammatory biomarker found in tears. The U.S. regulatory agency specifically took issue with the FDA-cleared predicated that TearLab chose to establish substantial equivalence. Get the […]
Invuity (NSDQ:IVTY) said late last week that its president and chief executive officer Philip Sawyer has resigned and will be replaced by board member Scott Flora on an interim basis. Flora has served as a member of the board since last November, and has held positions as prez, CEO and director of Omniguide. He has also held […]
TearLab Corp. (OTC:TEAR) lost a patent infringement lawsuit in a Canadian federal court against i-Med Pharma last month, according to the company’s annual report. In Feb. 2016, TearLab alleged that i-Med’s i-Pen Osmolarity test infringed 10 claims of TearLab’s Canadian patent for its own osmolarity test. Both systems are designed to measure the osmolarity of tears […]
TearLab Corp. (OTC:TEAR) is looking to keep its customer base and reduce the company’s cash burn rate with a new business model that will result in people losing their jobs, according to regulatory filings. The company said that it wants to focus resources on the development of its next-gen TearLab Discovery platform. Get the full story at […]
Shares in TearLab Corp. (NSDQ:TEAR) said last week that its board approved a 1-for-1 reverse split of its common stock. The company’s shares have fallen nearly 20% since the beginning of the month. The San Diego, Calif.-based company’s move reduced the total number of authorized shares of its common stock from 95 million t0 9.5 […]
TearLab Corp. (NSDQ:TEAR) said today it is undertaking a strategic restructuring that will result in the loss of 54 employees as the company looks to tighten the bolts in pursuit of positive cash flow. The San Diego, Calif.-based company said the reorganization of will cost approximately $300,000, but is expected to save the company $9.4 million […]
Interventional Spine said it has tagged ex-ConMed executive and 25-year medical veteran Joseph Darling as its new vice president and COO. Darling spent 7 years with ConMed, serving as the COO, executive veep and prez of ConMed Linvatec until February this year. Before his time at ConMed, Darling worked with Smith & Nephew, Wyeth-Ayerst Pharmaceuticals, Baxter […]
Intact Vascular said yesterday that it named medical device veteran Bruce Shook as its new president & CEO.
Histogenics has a new face in the corner office with the appointment of Peter Greenleaf, an AstraZeneca veteran favored by the board for his experience moving products toward commercialization.
The company has its eyes on an end-stage pivotal trial for NeoCart, a device that uses patients’ own cells to regenerate knee cartilage.