Hernia Patients in Pain as Skin Procedure Fails
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Digital Health: Where is the Action for Entrepreneurs?
Imagine your doctor recommends routine spleen removal surgery. When discussing your surgical options, the doctor tells you about da Vinci® - an increasingly used surgical robot. The doctor raves about the safety,...more
Pharmaceuticals, Medical Devices, Health Care & Life Sciences -
- Approval of Innovative Drugs and Key Sector Generic Drugs to be Expedited (Shanghai Securities Journal 2013-04-23):
Yesterday, we reported that FDA had announced its intentions of reclassifying sunlamp products and requiring labeling changes to include warnings discouraging young people from using them....more
Our firm is investigating possible violations of federal securities laws by officers and directors of Intuitive Surgical, Inc. (Intuitive Surgical) (Nasdaq: ISRG). A class action lawsuit has recently been filed against...more
The number of mobile applications (apps) available to consumers on their iPhones, Androids, and iPads is astonishing. As of January 2013, there were more than 775,000 different apps available to iPhone and iPad users. It...more
The U.S. Food and Drug Administration (FDA) recently issued a draft guidance document that could potentially require medical device manufacturers to report a wide variety of device improvements, ranging from routine updates...more
We are at the forefront of Chicago law firms representing women injured by surgical mesh, a product used to treat pelvic organ prolapsed (POP) and Stress Urinary Incontinence (SUI). Made of woven polyester, polypropylene or...more
I am often called upon to address the nature of how regulatory controls may apply to the organization of healthcare companies in their ability to create, deliver, and capture value (their ‘business models’). While no...more
A jury in California on Mar. 8 ordered DePuy Orthopaedics to pay over $8.3 million to a man who says the Johnson & Johnson subsidiary knowingly made and marketed a faulty hip replacement device.
The first jury verdict against Johnson and Johnson (J&J)’s Ethicon subsidiary has resulted in a powerful statement regarding the pharmaceutical company’s lack of adequate warnings of the health risks posed by the transvaginal...more
On February 22, 2013, the U.S. Food and Drug Administration (FDA) released a long-anticipated draft guidance document entitled Distinguishing Medical Device Recalls from Product Enhancements; Reporting Requirements. With the...more
On February 22, 2013, the Food and Drug Administration (“FDA”) issued draft guidance explaining when a change to a medical device constitutes a medical device recall as opposed to a “product enhancement.” This draft guidance...more
On February 19, 2013, FDA issued a supplemental notice of proposed rulemaking in the Federal Register, re-proposing amendments regarding information about pediatric subpopulations that must be submitted for certain medical...more
On February 8, 2013, 16 months after the statutory deadline, the Centers for Medicare & Medicaid Services (CMS) published in the Federal Register the final regulation implementing the physician payment transparency...more
Ventlab Corporation, based in Mocksville, NC, issued a recall over the summer for a number of manual resuscitator devices. The devices are designed to help patients who cannot breathe on their own. According to the FDA, a...more
Last week the Ninth Circuit created a new state-law cause of action against medical device manufacturers: “failure to warn the FDA.” The en banc opinion in Stengel v. Medtronic Inc., __ F.3d __, 2013 WL 106144, 13 C.D.O.S....more
As CES 2013 draws to a close, Michael Esquivel, a partner in Fenwick’s Start-ups and Venture Capital Group, identifies where the action is for entrepreneurs and investors in digital health and healthcare IT. According to...more
On April 29-30, 2013, FDA will hold a public workshop to discuss standardizing the format and content of medical device labeling and the development of a public repository/database that would provide access to the labeling of...more
On December 31, 2012, FDA issued a final guidance document entitled “eCopy Program for Medical Device Submissions” (“eCopy guidance”).
Section 745A(b) of the Federal Food, Drug, and Cosmetic (FDC) Act, which was added by...more
On December 31, 2012, FDA issued two final guidances that replace prior guidances related to the review of premarket submissions: “Refuse to Accept Policies for 510(k)s” and “Acceptance and Filing Reviews for Premarket...more
On December 31, 2012, the U.S. Food and Drug Administration (FDA) issued two new guidance documents on the minimum threshold of acceptability for medical device premarket submissions, which are titled “Refuse to Accept Policy...more
Beginning January 1, 2013, manufacturers and importers of certain medical devices will be required by the U.S. Internal Revenue Service (IRS) to pay a new 2.3 percent medical device excise tax on the sales of taxable medical...more
Foley Hoag and the Advanced Medical Technology Association (AdvaMed) collaborated on an important resource guiding manufacturers, importers, and producers of taxable medical devices through the newly released Internal Revenue...more
In response to wide criticism of the Food and Drug Administration’s (FDA) current review process, leaders of industry, academia and government have joined forces to create the Medical Device Innovation Consortium (MDIC), an...more
Last week, the IRS and the Treasury Department published final regulations regarding the medical device excise tax under § 4191 of the Internal Revenue Code (IRC). IRC § 4191, which was enacted by the Health Care and...more
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