330:"for the Company’s Xoft Axxent Electronic Brachytherapy System". The news led to a spike in stock volume and the price began to move, more than doubling by mid-January 2013. At that time, noting the move already made by the stock, a stock analyst reviewed the company's history and situation. With standard caveats, the analyst wrote that recent developments "could cause shares to double in a year and potentially triple over the next 24 months".
289:
offered Xoft’s Axxent
Electronic Brachytherapy System treatment, beginning in 2008. The hospital did not participate in the study in which the Axxent FlexiShield Mini — the device that has been recalled — was used in conjunction with intraoperative breast irradiation, nor has the hospital used the
190:
and photo finishing industries, Howtek elected to focus solely on the medical imaging market. The company acquired
Intelligent Systems Software, Inc. (ISSI) which had developed an approved CAD system for breast cancer. Subsequently, the company acquired Qualia Computing, Inc. of Ohio and its
338:
In the first quarter of 2020, iCAD had a GAAP net loss of $ 11.8m, and a non-GAAP adjusted net loss of $ 3.9m. Total revenues were $ 6.6m, with cash and cash equivalents of $ 14.3m. In April 2020, iCAD closed a registered direct offering for gross proceeds of ~$ 12.5 million.
317:
In
January 2013, an Inflection Point Investing stock analyst wrote in part, under "Risks": "Potential legal liability for a third-party related recall for a Xoft accessory product remains a small concern. We do not feel that this risk is material or anything to dwell upon."
218:, as well as other varieties where radiation therapy is indicated. The shield used in the system had been cleared by the FDA in June 2009 in an abbreviated process used for devices that are considered equivalent to products already on the market. That process, known as
301:
In July 2011, Zach's
Investment Research initiated coverage of the stock with a neutral rating and "positive on iCAD's fundamentals" but said "we believe caution is warranted until there is more clarity on the potential and likely liability related to a recently filed
234:
cancers is moving from conventional external beam therapy to shorter duration, more targeted therapy. The advantages of the Xoft System, which is FDA cleared for treatment anywhere in the body, have significant potential to improve patient care and quality of life.
238:
iCAD is also applying its patented technology and algorithms to the development of CAD solutions for use with digital mammography and CT Colonography (CTC). The company is also increasing distribution through large OEM partners, such as
293:
Starting in
February 2011, a series of parallel product liability suits have been filed in Orange Country Superior Court, totaling ten Jane Doe complainants and a number of John Doe spouses by August 2011, per the September 30, 2011
185:
From 1984 to 2000 Howtek successfully developed a series of products that improved the quality of digital imaging while reducing the price and complexity of digitizing systems. In 2001, foreseeing a decline in the
306:
lawsuit". While the company reported "strong revenue growth" for the first nine months of 2011, it also reported lawsuit and other legal expenses of $ 1.5 million as a component of a "Non
198:
iCAD originally focused on image-analysis products designed to help radiologists and other health-care providers detect cancers early. In
December 2010, iCAD expanded the company’s
279:. Full implications of the mistake had not been determined as of March 2011, but the company and the FDA had executed a recall on the FlexiShield Mini and were investigating.
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directly to cancer sites with minimal radiation exposure to surrounding healthy tissue, according to the company. The system was approved in the U.S. for treatment of early-stage
219:
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182:. The scanners converted printed, photographic and other hard copy images to digital form for use in the graphic arts, photo finishing and medical industries.
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Within a week of iCAD's closing on the Xoft acquisition, the Axxent FlexiShield Mini, used with its portable radiation device, the Axxent
Electronic
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filing by the company. The first and later of the plaintiffs, who consented to the experimental treatment, were represented by lawyer Jeff Milman.
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467:
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681:, January 15, 2013. Analysis by unnamed individual at IPI who was "long" (owned shares in) iCAD at time of writing. Retrieved 2013-01-17.
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271:, California. Eleven of those women have had mammograms, and all 11 showed tungsten. Two other women were treated in a study at
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iCAD continues to experience a period of growth in its cancer therapy business. Radiation treatment for breast, skin, and
260:
222:, takes less time than the procedure used to approve a new device, and it generally does not require tests on humans.
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subsidiary, CADx
Systems, Inc. These acquisitions brought together two of the three companies with clearance from the
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255:
System, was found to have left test subjects "riddled ... with hundreds of tiny particles of the heavy metal
691:"iCAD Reports Significantly Improved Medicare Payment for Intraoperative Radiation Therapy" (press release)
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178:
iCAD was founded in 1984 as Howtek, Inc. Howtek developed, manufactured and marketed digitizing systems or
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In
November, 2012, the company's products were granted a more-than-doubled reimbursement rate from U.S.
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The company stated that they "intend to continue to invest in targeted growth initiatives such as
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484:"iCAD Announces Merger With CADx Systems, Inc. and Qualia Computing, Inc." (press release)
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footprint by acquiring Xoft, Inc. It acquired Xoft's Axxent system, which delivers
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in their breast tissue and chest muscles." Twenty-seven of the cases occurred at
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436:"iCAD to Present at Two Investor Conferences in November 2016" (press release)
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556:"GE Healthcare and iCAD enter into Developmental Agreement"(press release)
500:"iCAD to acquire electronic brachytherapy specialist Xoft" (press release)
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166:. The iCAD technology platforms also include hardware and software for
195:(FDA) to market CAD solutions for breast cancer in the United States.
546:, March 21, 2011 (March 22, 2011 p. D5 NY ed.). Retrieved 2011-03-21.
256:
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159:
517:"ICad To Acquire Device Maker Xoft For $ 13.1M In Cash And Stock"
392:"iCAD, in midst of restructuring, names three new top executives"
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673:"Multiple Drivers Spur A Significant Inflection Point For iCAD"
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526:, December 16, 2010 1:58 P.M. ET. Retrieved 2011-03-21.
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737:"ICAD Inc (ICAD) Q1 2020 - Earnings Call Transcript"
659:, Oct. 26, 2011, 4:49 pm EDT. Retrieved 2011-11-23.
782:Medical technology companies of the United States
748:
468:"Howtek to Acquire Intelligent Systems Software"
792:Manufacturing companies based in New Hampshire
725:https://www.icadmed.com/assets/10Q-2020-Q1.pdf
653:"iCAD Reports Third Quarter Financial Results"
622:, March 9, 2011 7:59 pm. Retrieved 2011-11-23.
614:"Hoag patient sues after experimental therapy"
321:
772:Health care companies based in New Hampshire
328:Centers for Medicare & Medicaid Services
777:Manufacturing companies established in 1984
637:"iCAD, Inc: Initiating Coverage at Neutral"
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346:to drive the business over the long term."
603:, November 10, 2011. Retrieved 2011-11-23.
540:"Riddled With Metal by Mistake in a Study"
697:, November 5, 2012. Retrieved 2013-01-17.
452:"ICAD, Inc. > Description of Business"
290:Axxent FlexiShield Mini on any patients.
762:Companies based in Nashua, New Hampshire
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247:Tungsten particles left in test subjects
787:Medical imaging equipment manufacturers
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597:U.S. Securities and Exchange Commission
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261:Hoag Memorial Hospital Presbyterian
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573:"Axxent Electronic Brachytherapy"
273:Karmanos-Crittenton Cancer Center
671:Inflection Point Investing LLC,
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390:Susan Kelly (April 17, 2023).
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152:computer aided detection (CAD)
1:
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314:" of negative $ 6.8 million.
409:"icad, Inc. ... At A Glance"
193:Food and Drug Administration
7:
575:. Swedish Covenant Hospital
168:radiation therapy treatment
74:; 40 years ago
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593:"ICAD INC - FORM 10-Q ..."
322:Reimbursement rates raised
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283:Swedish Covenant Hospital
277:Rochester Hills, Michigan
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154:to support detection of
715:. Retrieved 2013-01-17.
458:. Retrieved 2017-04-21.
415:. Retrieved 2011-03-24.
62:Russell Microcap Index
504:medicalphysicsweb.org
148:Nashua, New Hampshire
91:Nashua, New Hampshire
21:ICAD (disambiguation)
655:, press release via
506:, December 17, 2010.
442:, November 10, 2016.
226:Trends in healthcare
19:For other uses, see
562:, 21 November 2007.
32:
544:The New York Times
490:, 1 December 2003.
212:endometrial cancer
164:colorectal cancers
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695:finance.yahoo.com
515:Jarzemsky, Matt,
440:globenewswire.com
334:Financial results
304:product liability
204:radiation therapy
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364:"Leadership"
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599:filing via
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751:Categories
595:, company
579:2011-03-21
456:nasdaq.com
373:2020-01-09
350:References
99:Key people
707:iCAD page
641:Zacks.com
524:Newswires
522:Dow Jones
310:Adjusted
140:iCAD Inc.
64:component
48:Traded as
31:iCAD Inc.
601:faqs.org
257:tungsten
200:oncology
180:scanners
160:prostate
287:Chicago
174:History
129:icadmed
124:Website
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413:Forbes
312:EBITDA
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