Serial medtech entrepreneur Dale Spencer died last week in Scottsdale, Ariz, according to the Medical Alley Association. Spencer helped found more than a dozen medical device companies, including SciMed, eV3, EndoMetabolic Solutions, ConcepTx Medical and Anulex Technologies. He also served on the boards of Boston Scientific (NYSE:BSX), Micro Therapeutics, Northstar Neuroscience, Spine Wave, Vertis Neuroscience, Velocimed […]
Anulex Technologies Inc.
Appeals court upholds win for Gore in patent war with STJ | Medtech legal news for the week of June 16, 2014
Judge dismisses Anulex from Xclose off-label lawsuit
A federal judge last week dismissed Anulex Technologies from a lawsuit alleging unfair & deceptive trade practices for alleged off-label promotion of its Xclose soft tissue repair device.
Bennie Evans sued Anulex, his back surgeon and the doctor’s medical practice in 2010, alleging claims of negligent misrepresentation, fraud, unfair and deceptive trade practices, and breach of implied warranty.
FDA lets Cooper’s Avaira Toric back on the market | Regulatory Roundup
Cooper Cos. (NYSE:COO) today announced that the U.S. Food and Drug Administration has granted a Special 510(k) clearance for CooperVision’s Avaira Toric two-week silicone hydrogel contact lenses for astigmatism.
CooperVision will re-launch Avaira Toric with shipments available for select distribution beginning in early May 2012.
Toshiba increases MR efficiency with M-Power | Regulatory Roundup
Toshiba Medical’s M-Power interface, a customizable MRI system designed to accelerate the scanning process and enhance diagnoses. M-Power will be availble for use on Toshiba’s Vantage Atlas, Vantage Titan, and Titan3T system.
The interface uses a drag and drop method that, Toshiba said, will enhance useability, allowing technicians to favorite the most frequently used scanning tools.
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Anulex announces FDA clearance of fiXate
Anulex Technologies, Inc. Announces FDA Clearance of the fiXate™ Tissue Band
New technology aids secure placement of spinal cord stimulator leads quickly and consistently
MINNETONKA, Minn.–(BUSINESS WIRE)–Anulex Technologies, Inc., a privately held medical device manufacturer, has announced the U.S. Food and Drug Administration (FDA) clearance to market the fiXate™ Tissue Band product, designed to secure Spinal Cord Stimulation (SCS) lead anchors to the fascia or interspinous/supraspinous ligament in patients with chronic, intractable pain of the trunk and/or limbs.
“This product addresses a need physicians have raised, enhancing confidence in the consistency of Spinal Cord Stimulation lead fixation while reducing procedure times.”
FDA warning letter leads to layoffs at Anulex
Following a February warning letter from the FDA, Anulex Technologies Inc. has had to adjust by having a round of layoffs.
President and general manager Tim Miller declined to say how many people were let go but acknowledged that such letters were “extremely disruptive to business.”
FDA slaps Anulex with warning letter
The FDA hit Anulex Technologies Inc. with a warning letter over “serious violations” at a facility in Minnetonka, Minn.
The watchdog agency says the company failed to obtain regulatory approval for a clinical study before enrolling human subjects.
Anulex’s study on its Xclose tissue repair system included the implantation of the device in 750 subjects, according the the warning letter.
Anulex reels in another $18 million
By Thomas Lee
Anulex Technologies Inc. of Minnetonka, Minn., raised $18 million in a Series E financing round and plans to raise at least $2 million more, according to CFO David Noel.
That brings Anulex’s total haul to about $75 million since 2003, including a $3.8 million sale debt and options offering in March.
Anulex Technologies pulls in $4 million
Fresh from the launch of its next-generation spinal tissue repair device, Anulex Technologies Inc. raised $3.8 million iun a debt and options sale to 11 investors, according to a regulatory filing.
