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Tearlab Corp.

FDA: TearLab’s Discovery MMP-9 test 510(k) fails to meet substantial equivalence

October 12, 2018 By Fink Densford

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 […]

Filed Under: 510(k), Clinical Trials, Diagnostics, Food & Drug Administration (FDA), Regulatory/Compliance Tagged With: Tearlab Corp.

FDA requests more info for TearLab’s eye diagnostic tech

April 11, 2018 By Sarah Faulkner

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 […]

Filed Under: 510(k), Diagnostics, Food & Drug Administration (FDA), Regulatory/Compliance, Wall Street Beat Tagged With: Tearlab Corp.

Invuity prez & CEO Sawyer steps down, Flora in as interim | Personnel Moves – March 13, 2018

March 13, 2018 By Fink Densford

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 […]

Filed Under: Business/Financial News Tagged With: Boston Scientific, CHF Solutions Inc., Endologix, endospan, Frequency Therapeutics, Intuitive Surgical, Invuity, Johnson and Johnson, Medtronic, milestonescientific, OmniGuide, Physeon, Precision Therapeutics Inc., Raumedic, Tearlab Corp.

TearLab loses Canadian patent spat with i-Med Pharma

March 8, 2018 By Sarah Faulkner

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 […]

Filed Under: Diagnostics, Legal News, Optical/Ophthalmic, Wall Street Beat Tagged With: imedpharma, Tearlab Corp.

TearLab cuts headcount in restructuring effort

December 22, 2017 By Sarah Faulkner

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 […]

Filed Under: Diagnostics, Optical/Ophthalmic, Wall Street Beat Tagged With: Tearlab Corp.

TearLab readies for reverse split

February 28, 2017 By Sarah Faulkner

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 […]

Filed Under: Diagnostics, Optical/Ophthalmic, Wall Street Beat Tagged With: Tearlab Corp.

TearLab to layoff 54 employees in restructuring

February 29, 2016 By Fink Densford

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 […]

Filed Under: Business/Financial News Tagged With: Tearlab Corp.

Ex-ConMed exec is Interventional Spine’s new Darling | Personnel Moves

July 8, 2015 By Fink Densford

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 […]

Filed Under: Business/Financial News Tagged With: CasMed Medical Systems, ConMed Corp., Dynatronics Corp, Global Kinetics Corp., Interventional Spine Inc, McKesson Corp., Medtronic, Sequent Medical, Tearlab Corp.

Ex-Neuronetics, Abiomed exec is Intact Vascular’s new CEO | Personnel Moves

July 15, 2014 By Brad Perriello Leave a Comment

Ex-Neuronetics, Abiomed exec is Intact Vascular's new CEO | Personnel Moves

Intact Vascular said yesterday that it named medical device veteran Bruce Shook as its new president & CEO.

Filed Under: News Well Tagged With: American Diabetes Assn., Arch Therapeutics, Intact Vascular, intersectent, Medigus Ltd., Personnel Moves, Philips, Precision Optics Corp., Spiracur, Tearlab Corp., VuComp Inc.

SEC dings Deerfield Capital Management $2M for short-selling violations

September 17, 2013 By Brad Perriello Leave a Comment

SEC dings Deerfield Management $2M for short-selling violations

Filed Under: News Well, Wall Street Beat Tagged With: Deerfield Management, Derma Sciences Inc., Insulet, Securities & Exchange Commission (SEC), Tearlab Corp.

Histogenics appoints a new CEO | Personnel Moves

June 11, 2013 By Sony Salzman Leave a Comment

fired/hired

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.

Filed Under: News Well, Orthopedics Tagged With: AstraZeneca plc, Histogenics, Natus Medical Inc., Personnel Moves, SteadyMed Therapeutics, Tearlab Corp.

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